Clinical trial NCT03625518: Mode of Induction in Fetal Growth Restriction and Its Affects on Fetal and Maternal Outcomes
Official title: Mode of Induction in Fetal Growth Restriction and Its Affects on Fetal and Maternal Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Fetal Growth Retardation
Induction of Labor Affected Fetus / Newborn
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2018-08-10
Enrollment: 280
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: mode of delivery
timeFrame: immediate
Secondary outcomes:
measure: composite neonatal outcome
timeFrame: 3 months after delivery
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Lis Maternity Hospital, Tel Aviv Sourasky Medical Center
Study officials:
References:
citation: Figueras F, Gratacos E. Update on the diagnosis and classification of fetal growth restriction and proposal of a stage-based management protocol. Fetal Diagn Ther. 2014;36(2):86-98. doi: 10.1159/000357592. Epub 2014 Jan 23.
citation: Baschat AA. Fetal growth restriction - from observation to intervention. J Perinat Med. 2010 May;38(3):239-46. doi: 10.1515/jpm.2010.041.
citation: Walker DM, Marlow N. Neurocognitive outcome following fetal growth restriction. Arch Dis Child Fetal Neonatal Ed. 2008 Jul;93(4):F322-5. doi: 10.1136/adc.2007.120485. Epub 2008 Apr 1.
citation: Boers KE, Vijgen SM, Bijlenga D, van der Post JA, Bekedam DJ, Kwee A, van der Salm PC, van Pampus MG, Spaanderman ME, de Boer K, Duvekot JJ, Bremer HA, Hasaart TH, Delemarre FM, Bloemenkamp KW, van Meir CA, Willekes C, Wijnen EJ, Rijken M, le Cessie S, Roumen FJ, Thornton JG, van Lith JM, Mol BW, Scherjon SA; DIGITAT study group. Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT). BMJ. 2010 Dec 21;341:c7087. doi: 10.1136/bmj.c7087.
citation: ACOG Practice bulletin no. 134: fetal growth restriction. Obstet Gynecol. 2013 May;121(5):1122-1133. doi: 10.1097/01.AOG.0000429658.85846.f9.
citation: Horowitz KM, Feldman D. Fetal growth restriction: risk factors for unplanned primary cesarean delivery. J Matern Fetal Neonatal Med. 2015;28(18):2131-4. doi: 10.3109/14767058.2014.980807. Epub 2014 Nov 14.
citation: Maslovitz S, Shenhav M, Levin I, Almog B, Ochshorn Y, Kupferminc M, Many A. Outcome of induced deliveries in growth-restricted fetuses: second thoughts about the vaginal option. Arch Gynecol Obstet. 2009 Feb;279(2):139-43. doi: 10.1007/s00404-008-0685-5. Epub 2008 May 28.