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

NCT03625518 | Unknown Early Phase 1

• 1 other identifier: 0114-18
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fetal Growth Retardation; Induction of Labor Affected Fetus / Newborn

Outcome Measures

Primary Outcomes (1)

• mode of delivery

  vaginal delivery, instrumental delivery or cesarean delivery

  immediate

Secondary Outcomes (1)

• composite neonatal outcome

  3 months after delivery

Study Arms (2)

prostaglandins

ACTIVE COMPARATOR

vaginal prostaglandins insertion (PGE2) for cervical ripening and induction

Drug: prostaglandins E2

intracervical balloon catheter with pitocin

ACTIVE COMPARATOR

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

Device: intracervical balloon catheter combined with pitocin

Interventions

prostaglandins E2 DRUG

insertion of vaginal PGE2 for up to 30 hours, up to two attempts for cervical ripening and induction

Also known as: dinoprostone slow release pessary

prostaglandins

intracervical balloon catheter combined with pitocin DEVICE

insertion of Foley catheter intra cervical and inflating the balloon with 50-60 cc of saline, with IV pitocin according to hospital protocol

intracervical balloon catheter with pitocin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Lis Maternity Hospital, Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Related Publications (7)

• 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.

  PMID: 24457811 BACKGROUND

• Baschat AA. Fetal growth restriction - from observation to intervention. J Perinat Med. 2010 May;38(3):239-46. doi: 10.1515/jpm.2010.041.

  PMID: 20205623 BACKGROUND

• 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.

  PMID: 18381841 BACKGROUND

• 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.

  PMID: 21177352 BACKGROUND

• ACOG Practice bulletin no. 134: fetal growth restriction. Obstet Gynecol. 2013 May;121(5):1122-1133. doi: 10.1097/01.AOG.0000429658.85846.f9.

  PMID: 23635765 BACKGROUND

• 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.

  PMID: 25354283 BACKGROUND

• 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.

  PMID: 18506461 BACKGROUND

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ayelet Dangot, MD

CONTACT

972524262658; adangot@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: August 10, 2018
• Study Start: September 1, 2018
• Primary Completion: July 1, 2020
• Study Completion: January 1, 2021
• Last Updated: August 10, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)