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

August 9, 2018 updated by: Tel-Aviv Sourasky Medical Center
to compare methods of induction of labor in fetal growth restriction and its effect on maternal and neonatal outcome

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

280

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Aviv, Israel, 64239
        • Lis Maternity Hospital, Tel Aviv Sourasky Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: prostaglandins
vaginal prostaglandins insertion (PGE2) for cervical ripening and induction
Drug: prostaglandins E2
insertion of vaginal PGE2 for up to 30 hours, up to two attempts for cervical ripening and induction
Other Names:
  • dinoprostone slow release pessary
ACTIVE_COMPARATOR: intracervical balloon catheter with pitocin
insertion of intra cervical balloon catheter combined with intravenous pitocin for ripening and induction of labor
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mode of delivery
Time Frame: immediate
vaginal delivery, instrumental delivery or cesarean delivery
immediate

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
composite neonatal outcome
Time Frame: 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
3 months after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2018

Primary Completion (ANTICIPATED)

July 1, 2020

Study Completion (ANTICIPATED)

January 1, 2021

Study Registration Dates

First Submitted

July 31, 2018

First Submitted That Met QC Criteria

August 9, 2018

First Posted (ACTUAL)

August 10, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 10, 2018

Last Update Submitted That Met QC Criteria

August 9, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0114-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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