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

Tel Aviv Sourasky Medical Center

Status and phase: Unknown; Early Phase 1

Conditions: Induction of Labor Affected Fetus / Newborn; Fetal Growth Retardation

Treatments: Device: intracervical balloon catheter combined with pitocin; Drug: prostaglandins E2

Study type: Interventional

Funder types: Other

Identifiers

NCT03625518

0114-18

Details and patient eligibility

About

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

Full description

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.

Enrollment: 280 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

---

280 participants in 2 patient groups

prostaglandins

Active Comparator group

Description:

vaginal prostaglandins insertion (PGE2) for cervical ripening and induction

Treatment:

Drug: prostaglandins E2

intracervical balloon catheter with pitocin

Active Comparator group

Description:

insertion of intra cervical balloon catheter combined with intravenous pitocin for ripening and induction of labor

Treatment:

Device: intracervical balloon catheter combined with pitocin