Fetal Growth Retardation, Induction of Labor Affected Fetus / Newborn
Conditions
Brief summary
to compare methods of induction of labor in fetal growth restriction and its effect on maternal and neonatal outcome
Detailed 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.
Interventions
insertion of vaginal PGE2 for up to 30 hours, up to two attempts for cervical ripening and induction
DEVICEintracervical balloon catheter combined with pitocin
insertion of Foley catheter intra cervical and inflating the balloon with 50-60 cc of saline, with IV pitocin according to hospital protocol
Sponsors
Tel-Aviv Sourasky Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mode of delivery | immediate | vaginal delivery, instrumental delivery or cesarean delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| composite neonatal outcome | 3 months after delivery | 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 |
Countries
Israel
Contacts
Primary ContactAyelet Dangot, MD
Outcome results
None listed