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

Fetal Growth Retardation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03625518
• Other study ID #: 0114-18
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: September 2018
• Est. completion date: January 2021

Study information

• Verified date: August 2018
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Ayelet Dangot, MD
• Phone: 972524262658
• Email: adangot[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 280
• Est. completion date: January 2021
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Induction of Labor Affected Fetus / Newborn

Intervention

Drug:
• prostaglandins E2
insertion of vaginal PGE2 for up to 30 hours, up to two attempts for cervical ripening and induction

Device:
• intracervical 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

Locations

Country	Name	City	State
Israel	Lis Maternity Hospital, Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (7)

American College of Obstetricians and Gynecologists. ACOG Practice bulletin no. 134: fetal growth restriction. Obstet Gynecol. 2013 May;121(5):1122-33. doi: 10.1097/01.AOG.0000429658.85846.f9. — View 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. Review. — View 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. — View Citation

Figueras F, Gratacós 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. Review. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mode of delivery	vaginal delivery, instrumental delivery or cesarean delivery	immediate
Secondary	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