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

NCT03625518 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2018-08-10

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-30
Primary Completion
2020-07-31
Completion
2021-01-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03625518 on ClinicalTrials.gov