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Gestational Diabetes: Induction Versus Expectant Management of Labour

NCT01058772 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 425

Last updated 2015-04-30

No results posted yet for this study

Summary

The purpose of this study is to determine whether, in Gestational Diabetes Mellitus (GDM) pregnancies, induction of labour at 38-39 weeks of pregnancy is superior to expectant management in terms of maternal and neonatal outcomes.

Conditions

  • Gestational Diabetes
  • Gestational Diabetes Mellitus
  • Diabetes Mellitus, Gestational
  • Pregnancy-Induced Diabetes
  • Diabetes, Pregnancy Induced

Interventions

OTHER

INDUCTION of LABOUR

Induction of labour will be performed by using dinoprostone 2 mg vaginally or dinoprostone 0.5 mg intracervically at 6-8h interval (up to 5 doses) or dinoprostone 10 mg vaginal device. Patients, in which cervical ripening does not occur (Bishop score \< 7) after 5 attempts with PGE2, will be offered either oxytocin or Foley catheter induction or C-section, according to local protocols.

Sponsors & Collaborators

  • IRCCS Burlo Garofolo

    lead OTHER

Principal Investigators

  • Salvatore Alberico, MD · Institute for Maternal and Child Health IRCCS Burlo Garofolo

  • Moshe Hod, MD · Helen Schneider's Hospital for Women - Rabin Medical Center

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Israel
  • Italy
  • Netherlands
  • Slovenia
  • Sri Lanka

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 NCT01058772 on ClinicalTrials.gov