Mode of Induction in Fetal Growth Restriction and Its Affects on Fetal and Maternal Outcomes

Study Overview
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Brief Summary
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to compare methods of induction of labor in fetal growth restriction and its effect on maternal and neonatal outcome

Detailed Description
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Intra uterine growth restriction (FGR) is a condition in which the fetus does not realize its growth potential in uterus. The excepted definitions of this condition are fetal weight estimation below the 10th percentile per gestational week. Severe growth restriction is defined as estimated weight below the 3rd percentile. It is well known that fetuses which are growth restricted are subjected to a higher degree of complications during pregnancy and delivery such as fetal distress, hypoxic damage, intra uterine fetal demise and complications in the neonatal period including prolonged NICU hospitalization, cerebral palsy, hypoxic ischemic encephalopathy and also long term affects such as neuro developmental complications. Common practice in managing these cases is induction of labor at term around 37 weeks of gestations to prevent these complications as it established that during this time there is a substantial rise in pregnancy complications including fetal demise. There are no clear guide lines how to induce labor in such cases and it is not known what is the safest and the most effective way to induce labor in these cases. Prior studies have found the rate of successful vaginal birth in these cases vary between 50 and 80%. There are a number of methods of labor induction and delivery available including the use of vaginal prostaglandins (PGE2) for cervical ripening, intracervical balloon catheter or planned cesarean. In most cases when aiming for vaginal delivery the choice is between ripening of the cervix with balloon catheter in combination with Pitocin or ripening with prostaglandins. It is not known which method is safer and more successful in growth restricted fetuses.

Official Title
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Mode of Induction in Fetal Growth Restriction and Its Affects on Fetal and Maternal Outcomes

Conditions
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Fetal Growth Retardation, Induction of Labor Affected Fetus / Newborn

Intervention / Treatment
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* Drug: prostaglandins E2
* Device: intracervical balloon catheter combined with pitocin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: singleton pregnancy fetal growth restriction defined as estimated fetal weight between the 3rd and 10th percentile per gestational age and are intended to deliver vaginally Gestational age between 36 and 42 weeks No known fetal anomalies Exclusion Criteria: Fetal estimated weight below the 3rd percentile Known fetal anomalies Contraindications for vaginal delivery: breech presentation, abnormal Doppler flow velocimetry of fetal ductus venosus. Oligohydramnios defined as amniotic fluid index below 5 cm Contraindication to the use of prostaglandins Fetal distress requiring emergent cesarean section All other condition preventing vaginal delivery as decided by a senior physician

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: prostaglandins<br>vaginal prostaglandins insertion (PGE2) for cervical ripening and induction | Drug: prostaglandins E2<br>* insertion of vaginal PGE2 for up to 30 hours, up to two attempts for cervical ripening and induction<br>* Other names: dinoprostone slow release pessary;|
| Active Comparator: intracervical balloon catheter with pitocin<br>insertion of intra cervical balloon catheter combined with intravenous pitocin for ripening and induction of labor | Device: intracervical balloon catheter combined with pitocin<br>* insertion of Foley catheter intra cervical and inflating the balloon with 50-60 cc of saline, with IV pitocin according to hospital protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mode of delivery | vaginal delivery, instrumental delivery or cesarean delivery | immediate | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite neonatal outcome | apgar score at birth, umilical cord blood gases, neonatal intensive care unit hospitalization,Intra ventricular hemorrhage, periventricular leukomalacia, meconium aspiration syndrome, sepsis, convulsion, perinatal death, need for hypothermia treatment | 3 months after delivery |