The term meconium is derived from the Greek word ‘Mekonion’, a word for Opium/Poppy juice. Aristotle coined the term meconium and reported opium like effects in neonates born through Meconium stained Amniotic Fluid.
Meconium is the first intestinal secretion from fetus. It starts as early as 10 weeks of gestation and incidence of intrauterine passage of meconium increases with the gestational age.
Amniotic fluid is the fluid present in amniotic sac, which surrounds the fetus, provides nutrition and maintains temperature of fetus.
Meconium may be passed during the intrauterine life in about 7-22% cases. Meconium passage is usually secondary to foetal hypoxia. Once meconium is passed, it contaminates amniotic fluid and exposes fetus to meconium.
Many studies have shown meconium stained amniotic fluid is associated with increased rate of foetal distress, increased perinatal morbidity and mortality.
Meconium staining of amniotic fluid during labour must be managed by a team of Obstetrician and Paediatrician well versed in neonatal resuscitation to: –
- Prevent intrauterine hypoxia.
- Prevent intrauterine meconium aspiration.
- Prevent meconium aspiration at birth.
Amnioinfusion is instillation of ringer lactate / normal saline into amniotic cavity either trans abdominally or transcervically. Trans cervical amnioinfusion is instillation of fluids through cervix during labour once membrane ruptures.
Once meconium stained amniotic fluid is detected during labour, especially in moderate to thick meconium, amnioinfusion is done.
Amnioinfusion dilutes and washes away thick meconium and increase amniotic fluid index.
Many studies have shown that amnioinfusion in moderate to thick Meconium stained amniotic fluid improves obstetric outcome, decrease in operative delivery and neonatal outcome. However few studies show no improvement in obstetric or neonatal outcome.
Studies have shown conflicting reports regarding the role of amnioinfusion in meconium stained amniotic fluid, so this study was conducted to evaluate the role of transcervical amnioinfusion in intrapartum management of meconium stained amniotic fluid.
AIMS & OBJECTIVES
Although intrapartum amnioinfusion was introduced more than 2 decades ago and is practised widely in United States, reports of its regular use in developing countries are scarce. This is probably due to prohibitive cost of a specially designed intrauterine catheter, and lack of equipment for electronic foetal monitoring.
Amnioinfusion is an inexpensive intervention whereas the cost of a caesarean section is about 50-100 folds that of amnioinfusion in a similar setting. In addition, shorter hospital stay reduces the cost of childbirth.
Therefore the present study is designed to evaluate its mode of delivery, maternal and perinatal outcome & cost benefit analysis in the form of operative intervention rate in this set-up.
So the aims and specific objectives of this study were----
Whether transcervical amnioinfusion has got any effect in mode of delivery in a labour complicated by meconium stained amniotic fluid.
(b) The effect on neonate by assessing 1 min & 5 min Apgar Score and Sick Newborn Care Unit (SNCU) admission.
(c) The effect of amnioinfusion in reducing the incidence of meconium aspiration syndrome and perinatal mortality.
(d) To study any complication of the procedure.
REVIEW OF LITERATURE
The term meconium is derived from the Greek word ‘Mekonion’, a word for Opium/Poppy juice. Aristotle coined the term meconium and reported opium like effects in neonates born through Meconium Stained Amniotic Fluid (MSAF). There have been references to meconium in association with perinatal deaths from as early as 1676.
Williams 1 observed in 1903 that a characteristic sign of impending asphyxia is the escape of meconium. However obstetricians realized that the detection of meconium during labour is problematic in the prediction of foetal distress or asphyxia.
Katz & Bowes (1992) emphasized the prognostic uncertainty of meconium by referring to the topic as a ‘murky subject’. Meconium may be passed during the intrauterine life in about 7-22% cases. The first intestinal discharge from newborns is Meconium, which is a viscous, dark green substance, composed of intestinal epithelial cells, lanugo, mucus, and intestinal secretions, such as bile. Intestinal secretions, mucosal cells, and solid elements of swallowed amniotic fluid are the 3 major solid constituents of meconium.
Water is the major liquid constituent, making up 85-95% of meconium. Intrauterine foetal distress can cause passage of meconium into the amniotic fluid further leading to Meconium Aspiration Syndrome (MAS).
In their review Ramin et3 describes, “Meconium in amniotic fluid is Environmental Hazard”.
There is a decreasing trend in the incidence of meconium aspiration syndrome, and numerous studies from around the world have been unable to find any association between meconium stained amniotic fluid and maternal age, maternal weight, parity, duration of labour, type of high risk factors, Oxytocin induction, type of anaesthesia, maternal smoking or alcohol consumption, sex, or weight of the foetus.
MECONIUM STAINED AMNIOTIC FLUID
Meconium may be passed during the intrauterine life in about 7-22% cases. Meconium staining of amniotic fluid begins 1 to 3 hours after the fetus passes meconium and increases with gestational age. Meconium is found in the foetal gut from 10 weeks gestation. There appears to be a link between gestational age and meconium passage. Meconium passage is infrequent / rare before 32- 34 wks gestation.
The incidence of meconium passage during labour increases with gestational age and reaches approximately 30% at 40 weeks gestation and 50% at 42 weeks. Meconium passage is seldom seen in preterm foetuses.
TABLE – 1: Meconium passage as function of gestational age
INFANTS WITH MECONIUM
Usher et al
Ostrea and Nazvi
Eden et al
Steer et al
Meconium passage into the Amniotic fluid may be ante partum or an intrapartum event. Various theories have been suggested to explain foetal passage of meconium and may, impart, explain the tenuous connection between the detection of meconium and foetal compromise. Intrauterine hypoxia causes increased intestinal peristalsis and relaxed anal sphincter resulting in meconium passage. Alternatively, evidence exists suggesting that meconium passage results from neural stimulation of a mature gastrointestinal tract. As the fetus approaches term, the gastrointestinal tract matures, and – motilin secreted.
Umbilical cord motilin levels are higher in infants who have passed meconium compared with those infants with clear amniotic fluid, and motilin levels are low in premature infants than in term and post term infants. Thirdly meconium passage could also follow vagal stimulation from common but transient umbilical cord compression and resultant increased peristalsis.
Foetal release of meconium could also represent physiological processes. Milleret al.7have stated, “The presence of meconium in amniotic fluid without sign of foetal asphyxia…is not a sign of foetal distress….”
Factors that promote the passage of meconium in Utero include the following:
(a) Pregnancy that lasts 42 weeks or longer.
(b) Secondary to a hypoxic stress.
(c) Placental insufficiency.
(d) Transient rise of PCO2 or fall in PO2 in the umbilical arteries due to pressure in the umbilical cord without metabolic acidosis.
(e) Maternal hypertension, Preeclampsia.
(g) Maternal drug abuse, especially of tobacco and cocaine.
(h) Foetal distress during labour.
(i) Transient pressure on the scalp during labour.
GRADING OF MECONIUM
Driscoll et al 8 studied meconium stained amniotic fluid and graded according to consistency. Grade –1 is light meconium stained fluid, which remained transparent when, collected in test tube. Grade -2 indicates an opaque solution of meconium in amniotic fluid. Grade –3 is meconium undiluted by any amniotic fluid.
Trimmer and Gilstrap using the weight percent of the solid component of meconium described the “meconiumcrit.” 10 ml of MSAF is taken in a graduated test tube and centrifuged at 1000 rpm for 10 minutes. The volume of the meconium sediment is expressed as percentage.
<10% solid component is considered light meconium,
10% to 30% considered moderate meconium, and
> 30% considered thick meconium.
It is important to estimate the quantity of meconium in the amniotic fluid, because, one of the determinants of Meconium aspiration syndrome (MAS) and neonatal mortality arising out of it, is the amount of meconium passed in the amniotic fluid by the fetus.
The “meconiumcrit” has been found to be unrelated to sex, birth weight, gestational age, foetal distress, maternal weight, age, parity, antenatal risk factors or Premature Rupture Of Membrane (PROM).
Sandhu et al studied 50 cases and depending on nature of meconium divided MSAF into three groups thin, moderate and thick, and Incidence was 46%, 12% and 15% respectively. One study evaluated patients with meconium passage during early and late labour and graded the presence of meconium as light or heavy. A prolonged second stage of labour, an increased incidence of operative intervention, such as forceps delivery and caesarean section, as well as a significantly higher incidence of neonatal morbidity and mortality, particularly in association with meconium aspiration, were all associated with heavy meconium passage early in labour. These abnormal heart rate patterns included late decelerations, severe variable decelerations, and decreased variability.
Although the aetiology is not well understood, effects of meconium are well documented. Meconium directly alters the amniotic fluid, reducing antibacterial activity and subsequently increasing the risk of perinatal bacterial infection. Additionally, meconium is irritating to foetal skin, thus increasing the incidence of erythema toxicum. However, the most severe complication of meconium passage in utero is aspiration of meconium stained amniotic fluid before, during, and after birth.
MECONIUM ASPIRATION SYNDROME
The passage of thick meconium in utero puts the neonate at risk for meconium aspiration syndrome (MAS). Meconium aspiration syndrome develops in 11to58% (mean 35%) of infants delivered from meconium-stained amniotic fluid and is associated with increased perinatal morbidity and mortality. Aspiration of meconium is regarded as an intrauterine event, although it can also happen during delivery with the baby's first breaths in foetuses with Oligohydramnios and cord compression.2 Aspiration of meconium is caused by hypoxia and hypercapnia, which work together to stimulate foetal gasping. Meconium aspiration syndrome is most strictly defined as the presence of any meconium below the vocal cords.
Coltart et al. 13 in his study gave strict criteria to diagnose MAS, which include a triad of--
1. The presence of meconium-stained amniotic fluid, meconium in trachea at birth followed subsequently by tachypnoea but without evidence of infection.
2. Chest X – ray consistent with MAS-scattered opacities with tendency to over expansion of lungs.
3. Histological confirmation of meconium in alveoli at autopsy.
Risk factors for MAS are foetal distress during labor, Oligohydramnios, thick meconium, placental insufficiencies and maternal drug abuse, especially of tobacco and cocaine.
Patho-physiology of meconium aspiration syndrome:
Meconium is a sterile admixture of numerous chemicals, including mucous glycoprotein, swallowed vernix caseosa, gastrointestinal secretions, bile, pancreatic and liver enzymes, plasma proteins, minerals, and lipids.
Mucopolysaccharides compose 80% of meconium's dry weight. The concentration of pancreatic and liver enzymes varies with gestational age.
While it is not known exactly which chemicals produce the violent inflammatory response seen in even mild MAS, it is believed that these are chiefly responsible. Biopsy samples reveal polymorphonuclear cell and macrophage infiltration. Alveolar edema soon occurs, along with hyaline membrane formation. Pulmonary haemorrhages may occur. Pathology specimens have also shown micro thrombi in the pulmonary vasculature.
Some investigators have found involvement of the distal arterioles within the lungs.
Normal foetuses have rapid and shallow respiratory movements in utero. If a fetus becomes distressed and hypoxemic these rapid movements cease. If hypoxia persists the foetal apnoea is replaced by deep gasping respiratory movements. The foetal lung fluid is replaced by aspirated amniotic fluid which contains meconium because foetal hypoxia can also stimulate colonic contraction and evacuation of meconium into the amniotic fluid. The pulmonary problems therefore are due to a combination of aspirated meconium causing mechanical obstruction of the major airways and a more peripheral chemical pneumonitis. If obstruction is complete, death occurs. Much more likely is partial airway obstruction with peripheral air trapping, often leading to air leak complications.
Prolonged exposure of the smaller airways and alveoli to the necrotizing effects of meconium can result in chemical pneumonitis with alveolar collapse and cellular necrosis. This results in increased airway reactivity and a generalized obstructive phenomenon that usually resolves slowly during the first year of life. Treatment is optimized to clear the aspirated amniotic fluid and meconium by immediate postnatal suctioning before the meconium disseminates peripherally. Although meconium is sterile per se it can be a good culture medium for microorganisms, especially E. coli and Staphylococcus aureus. Prevention of MAS remains problematic. There is usually lack of knowledge of the timing of meconium passage in utero, even in labour.
Effect of meconium on lung.
Complete obstruction of the airways results in atelectasis.
Partial obstruction causes air trapping and hyper distension of the alveoli. Hyper distension of the alveoli occurs from airway expansion during inhalation and airway collapse around inspissated meconium in the airway, causing increased resistance during exhalation. The gas that is trapped, hyper inflating the lung may rupture into the pleura (pneumothorax), mediastinum (pneumomediastinum), or pericardium (pneumo-pericardium).
Several constituents of meconium, especially the free fatty acids (eg, palmitic , stearic, oleic), have a higher minimal surface tension than surfactant and strip it from the alveolar surface, resulting in diffuse atelectasis.
Enzymes, bile salts, and fats in meconium irritate the airways and parenchyma, causing a diffuse pneumonia that may begin within a few hours of aspiration. All of these pulmonary effects can produce gross ventilation-perfusion (V-Q) mismatch. To complicate matters further, many infants with meconium aspiration syndrome (MAS) have primary or secondary persistent pulmonary hypertension of the newborn (PPHN) as a result of chronic in utero stress and thickening of the pulmonary vessels. Finally, though meconium is sterile, its presence in the air passages can predispose the infant to pulmonary infection.
MAS can present mildly as transient respiratory distress or severely as respiratory failure with hypoxemia, acidosis, and pulmonary hypertension. Classically, these babies are post mature and show signs of weight loss and yellow-stained nails, skin, and cord Rarely, MAS occurs before 38 weeks of gestation. Babies with meconium aspiration syndrome may have the following symptoms
- Cyanosis, or a bluish skin colour, at birth
- Difficult breathing or absence of breathing
- Thick, greenish amniotic fluid in the mouth and throat at birth
Poor muscle tone.
Modality of treatment for MAS
When meconium is detected during early labour, amnioinfusion with warm sterile saline may be beneficial. This procedure dilutes meconium in the amniotic fluid; therefore, incidence of foetal distress, operative delivery and the severity of aspiration may be minimized.
In order to reduce the risk of meconium aspiration, Carson et al. recommended oral De Lee tube suction by the obstetrician upon delivery of the baby's head. This is done before the infant takes its first breath. Tracheal intubation and meconium suction by the paediatrician are then performed. When aspiration occurs, intubation and immediate suctioning of the airway can remove much of the aspirated meconium.
The American Academy of Paediatrics Neonatal Resuscitation Program Steering Committee has promulgated the following guidelines for management of the baby exposed to meconium:
If the baby is not vigorous (Apgar 1-3):
Suction the trachea soon after delivery (i.e. before the first breath).
Suction for no longer than 5 seconds. If no meconium is retrieved, do not repeat intubation and suction.
If meconium is retrieved and no bradycardia is present, reintubate and suction.
If the heart rate is low, administer positive pressure ventilation and consider suctioning again later.
If the baby is vigorous (Apgar >5):
Clear secretions and meconium from the mouth and nose with a bulb syringe or a large-bore suction catheter. In either case, the remainder of the initial resuscitation steps should ensue: dry, stimulate, reposition, and administer oxygen as necessary. Linder et al Immediate tracheal suction is not a harmless intervention, and should be considered superfluous in a vigorous term neonate born with MSAF.
Maintain an optimal thermal environment and minimal handling because these infants are agitated easily and quickly become hypoxemic and acidotic Continue respiratory care, Oxygen therapy via hood or positive pressure is crucial in maintaining adequate arterial oxygenation. If mechanical ventilation is required, make concerted efforts to minimize the mean airway pressure and to use as short an inspiratory time as possible. Use of surfactant has not yet been proven to be efficacious in this setting and is under investigation. Although conventional ventilation commonly is used initially, oscillatory, high frequency, and jet ventilation are alternative effective therapies. Hyperventilation to induce hypocapnia and respiratory alkalosis is used as primary therapy for pulmonary hypertension. Inhaled nitric oxide has displaced the use of most intravenous pulmonary vasodilators. Pay careful attention to systemic blood volume and Blood Pressure. Volume expansion, transfusion therapy, and systemic vasopressors are critical in maintaining systemic BP greater than pulmonary BP, thereby decreasing the right-to-left shunt through the patent ductus arteriosus. Extra Corporeal Membrane Oxygenation (ECMO) is employed if all other therapeutic options have been exhausted.
MSAF AND PERINATAL OUTCOME
MSAF occurs in 7 to 22% of pregnancies and it is associated with significantly higher incidence of neonatal morbidity and mortality, particularly in association with meconium aspiration. MAS develop in 2% of cases. Ramin et al states that 1% infants developed MAS and 45% foetal acidemia. MAS were associated with correlates of foetal jeopardy during labour and delivery for example Fetal Heart Rate (FHR) abnormality, caesarean delivery for non-reassuring FHR patterns, as well as Forceps delivery and low apgar score.
Sandhu et al 10 studied 50 cases with MSAF and noted foetal heart rate variation in 21.7% of thin MSAF, 33.3% with moderately thick and 46.6%with thick meconium. Low apgar (<7) in 13.3%in thick MSAF as compared to none in thin MSAF and the overall perinatal mortality was 6%, perinatal morbidity 20% and incidence of caesarean rate 40% in thick MSAF compared to 13.6% in thin MSAF.
Bhide et al : studied 174 babies out of 2890 deliveries and states meconium passage in utero is considered a serious neonatal disorder causing increased neonatal morbidity.
Nathan et al states, meconium in amniotic fluid is an obstetric hazard with small but significantly increased risk of adverse foetal neonatal outcome. Incidence of perinatal mortality increased from0.3 to 1.5 per 1000 and severe foetal acidemia at birth-increased from 3/1000 to 7 per 1000, increase in caesarean rate from 7 to 14%.
Narli et al noted that neonates with thick meconium, as compared to those with thin meconium appeared to have significantly greater rates of acidemia, low apgar score at 1min and 5 min, more need for resuscitation and higher mortality rate. MAS and hypoxic ischemic encephalopathy were also higher in infants with thick meconium.
Miller et al Have not found MSAF to herald a poor outcome unless other signs of foetal distress are present. His study has reported that Meconium Stained liquor is a poor predictor of foetal asphyxia, acidosis or neonatal outcome.
METHODS TO DECREASE MECONIUM ASPIRATION.
Suppressing of fetal breathing:
Thinking that first breath is responsible for MAS, previously it was tried to reduce MAS by giving narcotic and suppressing breathing. Goodlin et al advocated sedating fetus in utero by administering narcotic drug to mother with MSAF in order to reduce foetal respiration and subsequently MAS. Further Dooley et al found no evidence that maternally administered narcotic in labour reduces MAS in newborn.
Carson et al. advocated oral De Lee tube suction by obstetrician followed by tracheal intubation and suction of meconium by the paediatrician, all before infants first breath. Upon delivery of the head of the baby, careful suctioning of the posterior pharynx decreases the potential for aspiration of meconium. The combined obstetric paediatric approach (perineal suctioning/intubation) to infant tracheal suctioning at delivery was described in a study that assumed that most meconium aspiration occurs during delivery.
Subsequently, however, it has been well documented that the combined technique of aggressive neonatal suctioning at delivery failed to eliminate all cases of meconium aspiration syndrome. A 2 percent incidence of this syndrome that persisted despite suctioning at delivery is believed to be due to foetal gasping and antenatal aspiration of thick meconium fluid, but the severity is reduced. Immediate tracheal suction is not a harmless intervention, and should be considered superfluous in a vigorous term neonate born with meconium stained amniotic fluid.
Physiotherapy has been tried to reduce MAS but is of less use.
The risk of meconium aspiration is high in patients, particularly when it is associated with episodes of foetal hypoxemia. Thin meconium is not associated with an increased perinatal mortality rate or with an increased incidence of meconium aspiration syndrome. Therefore, any mechanism by which thick meconium can be converted to thin meconium in the already potentially compromised fetus is postulated to have a positive affect on neonatal outcome--specifically, a decreased incidence of meconium aspiration syndrome.
Amnioinfusion was first described by Carey, at a postgraduate obstetrics and gynaecology course in 1957, but did not receive attention in clinical practice until the 1980s. In 1976, Gabbe et al. demonstrated in a monkey model that the removal of amniotic fluid produced variable decelerations of the foetal heart rate (FHR) tracing and that restoration of the amniotic fluid volume by infusing normal saline solution eliminated the decelerations. They demonstrated that variable decelerations related to Oligohydramnios and cord compression could be corrected by amnioinfusion, providing a "cushion" for the umbilical cord.
It was first described by Miyazaki & Taylor in 1983 as an intrapartum procedure. Miyazaki and Navrez in1985 used Amnioinfusion (AI) for resolution of variable deceleration. When meconium is detected, administering amnioinfusion with warm sterile saline may be beneficial. This procedure dilutes meconium in the amniotic fluid; therefore, the severity of aspiration may be minimized.
Stephen.et al 26 compared intrapartum Amniotic Fluid Index (AFI) and its relationship to foetal distress. AFI was measured in 50 consecutive labouring patients. Women with low AFI had a higher incidence of abnormal foetal heart rate during the first stage of labour (64% vs. 20%, p=0.02), meconium grade II and III at delivery (64% vs. 35%, p=0.05), and operative delivery for foetal distress (57% vs. 17%, p=0.02).
Amnioinfusion theoretically restores normal amniotic fluid volume and cushions the umbilical cord, which reduces cord compression, allowing for the resumption of normal function as demonstrated by net efflux of aspirated meconium and amniotic fluid in the previously hypoxic or asphyxiated fetus. Most studies have reported a decrease in newborn respiratory complications resulting from meconium aspiration in patients who receive amnioinfusion.
If the presence of meconium below the vocal cords and neonatal acidemia increase the risk for meconium aspiration syndrome prevention of these complications may reduce the severity of meconium aspiration syndrome. It is challenging to distinguish between the effects of amnioinfusion that may result from dilution of meconium and those that result from replenishment of amniotic fluid volume because the presence of thick meconium indicates a reduction in the volume of amniotic fluid in which the meconium is diluted.
Transcervical Amnioinfusion Protocol
The procedure is straight forward and uses equipment found in most hospital labour and delivery suites, including the following: a double lumen intrauterine pressure catheter, normal saline solution at room temperature, a foetal monitor and intravenous tubing. Although not required, continuous close monitoring using a foetal scalp electrode is recommended. To date, no benefit has been demonstrated for the use of infusion pumps or solution warmers.
After obtaining informed consent, a vaginal examination is performed to evaluate for cord prolapse, establish dilatation and confirm presentation. The foetal scalp electrode is placed, followed by an intrauterine pressure catheter to document resting tone (< 15 mm Hg). The normal saline is linked to the intravenous tubing. The tubing is primed as it would be for intravenous use. The tubing is then inserted into the infusion port on the three-way stopcock of the intrauterine pressure catheter.
Various protocols for Intrapartum Amnioinfusion.
In Collaborative Randomised Amnioinfusion for Meconium Project (CRAMP)-1: first 15 ml/min was given till 800 ml was transfused then 3 ml/min for rest of duration of labor.
CRAMP-2: used 500 ml over 30 min followed which another 500 l was given 30 drops / min.
800 ml bolus over 1 hour followed by continuous infusion of 180 ml/hr.
500 ml normal saline over 30 min followed by 3 ml/min.
600 ml over first hour and followed it with 150 ml/hr till full cervical dilatation.
Amnioinfusion for Oligohydramnios, 500 normal saline over 20-30 min if amniotic fluid index < 5,then additional 500 ml was infused, if AFI 5-10 additional 250 ml was introduced.
Fernand arias mentions use of 250 ml in 30 min and another 250 ml in next 30 min if required in cases of PROM, cases with foetal distress and 200 -300 ml over 30 min for variable deceleration.
Thick particulate meconium staining of the amniotic fluid.
Repeated severe variable foetal heart rate decelerations not responsive to conventional therapy.
Relative contraindication for Amnioinfusion
Polyhydramnios, Uterine hyper tonicity, multiple gestations, Amnionitis, Foetal anomaly, uterine anomaly, severe foetal distress, Non vertex presentation, Placenta previa, Abruptio placenta.
Risks / complications are
The greatest attractions of amnioinfusion have been that it is relatively easy to perform, inexpensive and safe. Amnioinfusion has been considered effective, easy to perform and safe. Although reports of severe or morbid complications associated with amnioinfusion have been rare, these complications are still a cause for concern. Few acute events have been attributed to Amnioinfusion. Isolated cases of umbilical cord prolapse have been reported, but they were well within the quoted occurrence rate of prolapse in pregnancies with vertex presentation where Amnioinfusion was not used.
Other reported infrequent complications of amnioinfusion include one case of uterine scar disruption and one case of iatrogenic polyhydramnios and elevated intrauterine pressure during amnioinfusion, which led to foetal bradycardia.
Five cases of amniotic fluid embolism have been reported in the medical literature. All were associated with other previously reported risk factors for amniotic fluid embolism.
Electrolyte abnormalities after amnioinfusion occurred in animal models; however, in one study, no significant changes were found in newborn serum electrolyte levels. One incidence of a temporal relationship between amnioinfusion and the unexpected development of respiratory failure in a healthy parturient has been reported, however; cause and effect were not established.
There are failures related to amnioinfusion. The possible causes for failure are inadequate infusions, rapid progression to second stage of labour and Cord complications; however, the cause of the greatest majority of failures of the procedure to improve outcomes is unknown.
TABLE-2: Complications associated with amnioinfusion 38
Hyper tonus uterus
Maternal cardiac or respiratory compromise
A prospective meta analysis study conducted by John Pierce et al analysed thirteen studies and found that Intrapartum amnioinfusion significantly reduced the frequency of MAS (OR 0.30; 95% CI 0.19,0.46) of meconium below vocal cords, and neonatal acidemia. Significantly lower overall caesarean rate (OR 0.74; 95% CI 0.59, 0.93) without increase in endometritis.
Another study by Cialone et al included 47 patients in the study group and 58 patients in the control group. The proportion of neonates with meconium below the vocal cords was reduced in the study group (two of 47 vs. 36 of 58, p<0.001). Umbilical artery pH was increased in the study group neonates (7.29 +/- 0.01 vs. 7.25 +/- 0.009, p<0.05). The rate of neonatal acidemia was reduced in the study group (4 of 45 vs. 12 of 50, p < 0.05). The rate of meconium aspiration syndrome was reduced in the study group (1 of 47 vs. 8 of 58, p < 0.05). Maternal and neonatal morbidity rates were similar, and concluded that prophylactic amnioinfusion should be considered a possible addition to the intrapartum management of patients with particulate meconium-stained amniotic fluid.
A study conducted by Wenstrom et al included 85 patient receiving amnioinfusion and found that patients receiving amnioinfusion had significantly fewer low 1 min Apgar score, less meconium below vocal cord, and a significantly lower incidence of operative delivery.
A Multi-centered randomized study; a CRAMP I study showed that Caesarean section rates were similar (amnioinfusion 70/167 vs. controls 68/159: RR 0.98, 95%CI 0.76-1.26). The incidence of MAS was lower than expected on the basis of previous stud y (4/162 vs. 6/163; RR 0.67, 95%CI 0.19-2.33) there were no perinatal death. There were no significant differences between any of the subsidiary outcomes.
In another study (CRAMP II) there was no difference in risk for caesarean section in two groups (amnioinfusion 9.5% vs. 12.3%; RR 0.84, 95% CI 0.53-1.32). MAS was significantly less frequent in amnioinfusion group (3.1% vs. 12.8%; RR 0.24, 95%CI 0.12 0.48), and there were trends towards few perinatal deaths (1.2% vs. 3.6%; RR 0.34, 95%CI 0.11-1.06).
In another study by Eriksen et al Amnioinfusion was given to 65patients and 59 patients as control. Incidence of foetal distress (16 of 65 vs. 8of 59) and caesarean section for foetal distress (7of 65 vs. 7of 59) was not significantly different between two groups. The rate of meconium below vocal cords (1 of65 vs. 8 of 59) was significantly lower in patients receiving amnioinfusion (RR 0.09, CI 0.02 and 0.82, p=0.02). Two cases of MAS occurred in control group, none in amnioinfusion group.
Sadavsky et al. 42 conducted a prospective, randomised study to assess the safety and effectiveness of prophylactic transcervical amnioinfusion. They found that there was no amnioinfusion-related complication and that there was no meconium below the vocal cords (0% vs. 29%, p0.05). They also came to the conclusion that transcervical amnioinfusion is a straightforward, safe procedure.
A study by Hofmeyr 40 analysed twelve studies, most involving small number of participants were included. Amnioinfusion was linked to a lower risk of the following conditions under limited perinatal surveillance: meconium aspiration syndrome (relative risk 0.24, 95% confidence interval 0.12 to 0.48); neonatal hypoxic ischemic encephalopathy (relative risk 0.07, 95% confidence interval 0.01 to 0.56); and neonatal ventilation or intensive care unit admission (relative risk 0.56, 95% confidence interval 0.39 to 0.79); there was also a He concluded Amnioinfusion is associated with improvements in perinatal outcome, particularly in settings where facilities for perinatal surveillance are limited. The trials reviewed are too small to address the possibility of rare but serious maternal adverse effects of amnioinfusion.
Another study by Spong and colleagues, addressed this issue in a prospective, randomized study in which patients assigned to a control group received "standard care," and a study group, which received included Amnioinfusion for repetitive variable decelerations. There was no difference in outcome between the prophylactic- Amnioinfusion group and the standard-care group. They concluded that the benefit of Amnioinfusion in patients with Meconium-stained amniotic fluid may be the result of alleviation of variable foetal heart rate decelerations, rather than meconium dilution. Amnioinfusion among women attempting vaginal birth after caesarean delivery is found to be safe.
TABLE–3: Intrapartum Amnioinfusion and Caesarean Rates
GROUP n (%)
GROUP n (%)
Sandovsky et al
Macri et al
Spong et al
Cialone et al
Hofmeyr et al
Mohomed et al
Erikson et al
Moodley et al
Khosla et al
TABLE–4: Intrapartum Amnioinfusion and Presence of
Meconium below vocal cord
GROUP n (%)
GROUP n (%)
Sandovsky et al
Macri et al
Spong et al
Hofmeyr et al
Erikson et al
Khosla et al
TABLE-5: Intrapartum Amnioinfusion and Meconium aspiration
GROUP n (%)
Sandovsky et al
Macri et al
Spong et al
Hofmeyr et al
Mohomed et al
Khosla et al
MATERIALS & METHODS
This study entitled “ROLE OF INTRAPARTUM TRANSCERVICAL AMNIOINFUSION IN MECONIUM STAINED AMNIOTIC FLUID AND NEONATAL OUTCOME” was conducted in the Department of Obstetrics & Gynaecology, Darbhanga Medical College & Hospital, Laheriasarai, Bihar.
STUDY AREA- Department of Obstetrics & Gynaecology, Darbhanga Medical College & Hospital.
STUDY POPULATION- Labour cases attending our Obstetric emergency after 37 weeks of pregnancy who exhibit meconium stained liquor after spontaneous or artificial rupture of membranes.
STUDY PERIOD- From 1st March 2015 to 31st August 2016 –for
a period of one year and half years.
SAMPLE SIZE- Total 100 cases (meconium stained-50 & without meconium stained-50) were taken into consideration depending upon inclusion and exclusion criteria.
SAMPLE DESIGN- All consecutive cases where interventions done were included according to the study criteria.
INCLUSION CRITERIA: -
(a) All pregnant patient at or after 37 weeks with meconium stained liquor.
(b) Singleton pregnancy.
(c) Cephalic presentation.
EXCLUSION CRITERIA: -
(b) Multiple gestations
(c) Cord Prolapse
(d) Ante partum haemorrhage
(f) Foetal congenital anomaly
(h) Maternal cardiovascular / respiratory disease
(i) Severe foetal bradycardia
(1) 100 women in labour with meconium stained liquor were randomised to receive either transcervical amnioinfusion (50) or routine obstetric care.
(2) Clinical history, physical examinations, and abdominal and vaginal examinations findings.
(3) Size-8 rubber catheter with 2.5 mm in outer diameter.
(4) Normal saline bottles, infusion set, moist oxygen.
(5) Monitoring of FHR by intermittent auscultation with a stethoscope (every 20-30 minutes, and between and at the end of contraction.)
(6) Uterine tone and frequency of uterine contractions were assessed by palpation.
(7) Monitoring of labour by partogram.
(8) Pre-designed format for data collection.
(9) Various statistical chart and analytical software.
STUDY DESIGN- Prospective Randomised Controlled Study.
PARAMETERS TO BE STUDIED-
(a) Mode of delivery and operative intervention rates.
(b) Respiratory distress
(c) Assessment of APGAR score.
(d) SNCU admission rate.
(e) Meconium Aspiration Syndrome as diagnosed by X-ray.
(f) Meconium below vocal cords.
(g) Perinatal mortality rate.
(h) Post-partum complications in the mother.
Hundred women at term in early labour with meconium stained amniotic fluid were randomized to receive either Transcervical Intrapartum amnioinfusion with saline (50) or routine obstetrical care (50). The selection criteria for all patients was similar i.e., a singleton gestation, vertex presentation, gestational age ≥37 weeks and cervical dilatation <5 cm, and an adequate pelvis.
Following an informed written consent all the patients were given a single dose of broad-spectrum antibiotic intravenously. A 8 -size red rubber tube was introduced between foetal head and dilating cervix in to amniotic cavity and 500 ml of normal saline was infused over 30 min, this is followed by continuous infusion of normal saline at 3 ml per min. The foetal heart rate and uterine tone were assessed continuously during the intervention. If the uterine tone was persistently elevated, the infusion was discontinued and the uterine pressure was allowed to equilibrate over five minutes. Resting uterine tone was reassessed by palpation. Throughout the procedure----
- Continuous monitoring of foetal heart rate was done
- Patient was monitored for pulse /blood-pressure /temperature every 30 min
- Mother and neonate were followed for 5-7 days postnatally.
Caesarean sections were carried out in either group if foetal distress persists.
All neonates were managed by standard protocol of immediate oropharangeal suction followed by endotracheal suction. During foetal oropharyngeal suction, the presence of meconium below the vocal cords was documented. Admission to the nursery and complications, including mortality, were noted. An X-ray chest of babies with MAS was done.
ANALYSIS OF DATA-
Sample size calculation was done by using StatCalc 7.00 (Acastat software, Leesburg). Collected data was plotted in various pie-charts, histogram, chi-square table for graphical representation. Finally data found analysed with statistical software Medcalc11.3.0. Proportion were analysed by using chi-square test.
The differences were expressed considered to be statistically significant with P <0.05 at 95% CI.
RESULTS & ANALYSIS
TABLE-6: DISTRIBUTION OF TOTAL PATIENTS
ACCORDING TO MATERNAL AGE:
ROUTINE CARE GROUP
In this study, total 100 patients were taken into consideration, among which 50 had undergone amnioinfusion and another 50 received routine care.
Maximum patients were of 21-25 yrs of age =45.
There was no significant difference between study and control group according to maternal age because the differences found significant were not statistically as the p value was >0.05.
DISTRIBUTION OF TOTAL PATIENTS ACCORDING TO MATERNAL AGE.
TABLE-7: DISTRIBUTION OF TOTAL PATIENTS
ACCORDING TO GESTATIONAL AGE.
There was no significant difference between study and control group according to gestational age.
Increased incidence of MSAF is noted in gestational age >39 wks.
Large group of cases belong to gestational age 39-40 wks.
DISTRIBUTION OF TOTAL PATIENTS ACCORDING TO GESTATIONAL AGE.
TABLE-8: DISTRIBUTION OF TOTAL PATIENTS
ACCORDING TO PARITY.
In the amnioinfusion group, 22(44%) were primigravida & 28(56%) were multigravida. In the control group patients, 28(56%) were primigravida &22(44%) were multigravida.
There was no significant difference between study and control group according to parity because the differences found were not statistically significant as the p value was>0.05.
DISTRIBUTION OF TOTAL PATIENTS ACCORDING TO PARITY.
TABLE-9: DISTRIBUTION OF PATIENTS ACCORDING
TO RISK FACTORS.
In this study, it is clear from the above chart that; incidence of MSAF is more in pre-eclampsia & post-dated pregnancy (18% & 26% respectively).
No significant statistical difference between study and control group was seen according to the mentioned risk factors.
DISTRIBUTION OF PATIENTS ACCORDING TO RISK FACTORS.
TABLE-10: DISTRIBUTION OF TOTAL PATIENTS
ACCORDING TO LABOUR
Among the study group, 30(60%) went into spontaneous labour & 20(40%) into induced/augmented labour. Whereas in the control group, 33(66%) into spontaneous labour & 17(34%) into induced/augmented labour.
The differences found between these two groups were not statistically significant as the p value was >0.05.
DISTRIBUTION OF TOTAL PATIENTS ACCORDING TO LABOUR CHARACTERISTICS.
TABLE-11: DISTRIBUTION OF TOTAL PATIENTS
ACCORDING TO MODE OF DELIVERY.
In the amnioinfusion group, 40 patients (80%) had FTND as compared to only 27(54%) patients of control group patients.
The incidence of Forceps delivery was almost same in the study group (10%) and control group (12%).
The incidence of Caesarean section rate was 10% in the study group as compared to 34% in control group. Statistically significant difference was there as p value was <0.05.
DISTRIBUTION OF TOTAL PATIENTS ACCORDING TO MODE OF DELIVERY.
TABLE-12: DISTRIBUTION OF TOTAL PATIENTS
ACCORDING TO SEX OF THE BABY:
ROUTINE CARE GROUP
In the study group, 30(60%) patients delivered boy babies and another 20(40%) patients delivered girl babies. In the control group, 27(54%) patients delivered boy babies and another 23(46%) patients delivered girl babies.
No significant differences between study and control group were found as the p value was >0.05.
DISTRIBUTION OF TOTAL PATIENTS ACCORDING TO SEX OF BABIES.
TABLE-13: COMPARATIVE EVALUATION OF
NEONATAL APGAR SCORE AT 1 MIN:
AT 1 MIN
Number of cases with APGAR @ 1 min, ≤6 were 10(20%) in the study group as compared to 25(50%) in control group.
Number of cases with APGAR @ 1 min, >6 were 40(80%) in the study group as compared to 25(50%) in control group.
There was a significant improvement of APGAR score @ 1 min, which was statistically significant (p<0.05).
COMPARATIVE EVALUATION OF NEONATAL APGAR SCORE @ 1 MIN.
TABLE-14: COMPARATIVE EVALUATION OF
NEONATAL APGAR SCORE AT 5 MIN:
AT 5 MIN
Number of cases with APGAR @ 5 min, ≤6 were 1(2%) in the study group as compared to 2(4%) in control group.
Number of cases with APGAR @5 min, >6 were 49(98%) in amnioinfusion group
There was no significant improvement of APGAR score @5 min In amnioinfusion group.
The difference found was statistically not significant (p>0.05).
COMPARATIVE EVALUATION OF NEONATAL APGAR SCORE @ 5 MIN.
TABLE-15: DISTRIBUTION OF TOTAL PATIENTS
ACCORDING TO BIRTH WEIGHT OF BABIES
There was no significant difference between the study and control group In relation to birth weight of babies (p>0.05).
DISTRIBUTION OF TOTAL PATIENTS ACCORDING TO BIRTH WEIGHT OF BABIES.
TABLE-16: COMPARATIVE EVALUATION
OF NEONATAL OUTCOME:
Meconium below vocal cord
Respiratory distress was markedly reduced in amnioinfusion group 8(16%) as compared to 25(50%) in controls (p=0.0053).
MAS was markedly reduced by amnioinfusion. It occurred in 2(4%) in the study group & 10(20%) in the control group (p=0.0433).
Meconium below vocal cord was evident in only 6(12%) patients in the study group, compared to 21(42%) in the control group (p=0.0071).
SNCU admission were 14(28%) in the control group compared to 3(6%) in the study group (p=0.0153).
Perinatal mortality was nil in the study group as compared to 1(2%) in the control group (statistically not significant). So neonatal outcome was significantly better in the study group.
COMPARATIVE EVALUATION OF NEONATAL OUTCOME.
TABLE-17: COMPARATIVE EVALUATION OF
Maternal complications in both amnioinfusion group and study group were same. There was no increased incidence of maternal complications
because of the procedure.
Although Intrapartum Amnioinfusion was introduced more than 2 decades ago, reports of its regular use in developing countries are scarce. This is due to the lack of specially designed intrauterine catheter & equipment for electronic foetal monitoring. The findings of the present study are that-amnioinfusion is a safe, technically feasible and easily affordable procedure in a rural set-up where most of the patients are of lower socio-economic status.
As the participants were from same area and similar backgrounds, the study and control groups were balanced with respect to socio-demographic variables & baseline obstetric characteristics.
In this study there was no significant difference between study group and control group according to age, parity, gestational age, hypertension/pre-eclampsia, post-dated pregnancy, anaemia, onset of labour, sex and birth weight of babies.
James mentions incidence of MSAF increases with gestational age and reaches approximately 30% at 40 weeks and 50% at 42 weeks. High incidence of MSAF was noted in high risk pregnancy in our study. Similarly one study noted increased incidence of MSAF is more in HTN/pre-eclampsia and post-dated pregnancy.
Sandu et al noted majority (80%) of cases with MSAF belonged to the age group of 21-30 years. In our study 77% of cases with MSAF belong to the same age group.
In this study, there was a trend towards lower caesarean delivery rate in the amnioinfusion group. The incidence of caesarean section rate was 10% in the study group as compared to 34% in control group(p<0.05).The probable explanation for the lower caesarean section rate in the study group is that by increasing the amniotic fluid volume around the fetus, amnioinfusion reduces the risk of foetal distress caused by umbilical cord compression. In the study group, 80% (40/50) patients had a vaginal delivery as compared to only 54 %( 27/50) of control group patients (p< 0.05). The incidence of Forceps delivery was almost same in study group (10%) and control group (12%).
Study by Macri et al showed that the rate of caesarean section was significantly reduced in amnioinfusion group. Wenstrom et al: also showed that patients receiving amnioinfusion had significantly lower incidence of operative delivery.
There was no significant difference between study group and control according to sex and birth weight of fetus (P>0.05). Number of cases with APGAR @ 1 min, ≤6 were 20% (10/50) in study group as compared to 50 %( 25/50) in control group. There was significant improvement in APGAR score @ 1 min (P = 0.0033) in amnioinfusion group, suggesting a lesser need for immediate neonatal intervention, for which equipments and trained personnel are often lacking developing countries. This study correlated with CRAMP -I study which showed improvement in 1min APGAR. In this study number of cases with APGAR @ 5 min, ≤6 were 2/50 (4%) in control group as compared to 1/50 (2%) in study group. In our study there was no significant improvement in 5 min APGAR (P = 1).
However CRAMP-2, meta analysis study shows significant reduction in incidence of 5 min APGAR < 7.
Meconium below the vocal cords was evident in only 12% (6/50) patients receiving amnioinfusion, compared to 42 %( 21/50) in the non-infusion group of patients (P=0.0071). Meconium aspiration syndrome was reduced markedly in amnioinfusion group. It occurred in 4% of cases in the study group and 20% of cases in the control group (p=0.0433). Fewer cases of MAS & meconium below vocal cord would reduce the burden of complications in developing countries with poor resources. Respiratory distress was markedly reduced in amnioinfusion group 8(16%) compared to 25(50%) in controls. (P=0.0053). SNCU admissions were 14(28%) in control group compared to3 (6%) in amnioinfused group (P=0.0153). Perinatal mortality in the study group was nil as compared to 2% in the control group (statistically not significant).
Many studies have shown decreased incidence of foetal distress, operative delivery (Table-3), meconium below vocal cord (Table-4), meconium aspiration syndrome (Table-5) and without much increase in maternal complications (Table-6).
CRAMP-1 and CRAMP-2 meta-analysis study shows significant reduction in several measures of perinatal morbidity in amnioinfused group: meconium aspiration syndrome, NICU admission, and 5min APGAR score.
In this study 10cases of MAS occurred in control group and 2 in amnioinfusion group. .Macri et al noted the rate of caesarean section; meconium aspiration and meconium aspiration syndrome were significantly reduced in amnioinfusion group. A study by Wenstrom et al showed that patients receiving amnioinfusion had significantly fewer 1 min APGAR score, less meconium below vocal cords and a significantly lower incidence of operative delivery.
In this study, complications in both Amnioinfusion and study group were same. There was no increased incidence of fever/ endometritis because of the Procedure. Wenstrom et al 41 stated that neither the method employed nor the number of infusions performed appears to significantly increase the risk of complication. CRAMP-2, Meta study shows no significant increase in maternal complication because of the procedure.
Although an accurate cost-benefit analysis of amnioinfusion is difficult, the possible cost savings are enormous. The average cost of a caesarean section is about 50-100 times more than that of an amnioinfusion in a same set-up. In addition, shorter hospital stay reduces the cost of childbirth where health resources are overstretched. Furthermore emergency caesarean section can have serious consequences on maternal health, especially if the operation is performed in a suboptimal condition in an under-resourced facility.
SUMMARY & CONCLUSIONS
This study was carried out in the Departments of Obstetrics and Gynaecology, DMCH, Laheriasarai, between March 2015 to August 2016. A total of 100 cases with intrapartum passage of meconium were selected and a prospective randomized study was carried out.
Patients with meconium stained amniotic fluid were selected randomly. The study group (50) comprised patients who received Amnioinfusion; the control group (50) received routine obstetric care for meconium. There was no significant difference between study group and control according to age, parity, and gestational age, HTN/pre-Eclampsia, post-dated pregnancy, anaemia.
There was no significant difference between study group and control whether membranes were ruptured spontaneously or induced. Transcervical amnioinfusion is effective in improving both maternal and perinatal outcome by the fact that-
(a) It increases the chances of normal delivery. There is significant increased incidence of normal delivery (80%) in the study group as compared to (54%) control group (p<0.05).
(b) Significant reduction in caesarean rates from 34% to 10% (p<0.05).
(c) Significant improvement in APGAR @ 1min (p=0.0033).
(d) Significant decrease in the incidence of respiratory distress (p=0.0053), meconium below vocal cord (p=0.0071), meconium aspiration syndrome (p=0.0433) and SNCU admission. (p=0.0153).
(e) Perinatal mortality was nil in the study group as compared to 1(2%) in the control group, though statistically not significant.
(f) There was no increased incidence of any maternal complications.
Intrapartum Transcervical Amnioinfusion for MSAF is a simple, safe and Inexpensive intervention. It is effective in reduction of operative intervention rates and MAS in the set-up not equipped for electronic foetal monitoring and specialised neonatal care. This implies that a lack of modern facilities for peripartum care should not deter one from using amnioinfusion in the presence of MSAF. This study suggests that substantial benefits can arise from performing amnioinfusion in most of the district hospitals in developing countries.
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DATA COLLECTION FORMAT
DATA COLLECTION FORMAT:
(c) Registration No.
(d) Name of the husband
(f) Occupation of the husband
(g) Occupation of the wife
(h) Unit concerned
PAST MEDICAL/SURGICAL HISTORY-
PERSONAL HISTORY/DRUG HISTORY-
PAST OBSTETRIC HISTORY-
ABOUT CURRENT PREGNANCY-
No of ANC
Referred or not
Stage of labour
Pulse Neck vein/gland
Fundal height Lie
Membranes ruptured at-
Given at…../not given.
Oxytocin used/ not used. If used …..units.
Any other drug used/ not.
MODE OF DELIVERY:
Forceps/LSCS. (If LSCS, indication)
Timing of delivery.
Apgar @ 1 min
Apgar @5 min
Respiratory distress……… Yes/No.
Meconium aspiration syndrome….Yes/No.
Any maternal complication……………….
AI - AMNIOINFUSION.
AF - AMNIOTIC FLUID
AFI - AMNIOTIC FLUID INDEX
ARM - ARTIFICIAL RUPTURE OF MEMBRANES
BP - BLOOD PRESSURE
CRAMP - Collaborative Randomised Amnioinfusion for Meconium Project
CI - CONFIDENTIAL INTERVAL
ECMO - EXTRACORPOREAL MEMBRANE OXYGENATION
FHR - FETAL HEART RATE
MAS - MECONIUM ASPIRATION SYNDROME
MSAF - MECONIUM STAINED AMNIOTIC FLUID
n – NUMBER
SNCU – SICK NEWBORN CARE UNIT
OR – ODDS RATIO
PROM - PREMATURE RUPTURE OF MEMBRANE
rpm - REVOLUTIONS PER MIN
RR - RELATIVE RISK
VBAC - VAGINAL BIRTH AFTER CAESAREAN
Vs – VERSUS
Wk – WEEK
% - PERCENTAGE