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Induction of Labor Versus Expectant Management of Large for Gestational Age/Macrosomic Babies at Term. A Multi-center Trial

NCT02315820 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 474

Last updated 2014-12-12

No results posted yet for this study

Summary

The equipoise whether to Induce pregnant women with suspected large for gestational babies or suspected macrosomia babies at term pregnancy is not solved yet. Only 2 relatively small studies were conducted to answer this clinically important question.

The investigators will conduct a randomized controlled, multi-center study large enough to confirm or refute our assumption that induction of labor at term reduces the shoulder dystocia prevalence significantly compared to expectant management.

Conditions

  • Macrosomia
  • Induction of Labor
  • Expectant Management
  • Shoulder Dystocia

Interventions

PROCEDURE

Induction of labor group (Group I)

Women at 38-40+3 weeks with estimated fetal weight 3800-4500 will be offered ripening and IOL.

Sponsors & Collaborators

  • The Baruch Padeh Medical Center, Poriya

    lead OTHER_GOV

Principal Investigators

  • Yuri Perlitz, MD · Director-High risk unit and maternal department

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2018-12-31
Completion
2019-07-31

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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 NCT02315820 on ClinicalTrials.gov