NCT01058772

Brief 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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
425

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2010

Longer than P75 for not_applicable

Geographic Reach
5 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 29, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 30, 2015

Status Verified

April 1, 2015

Enrollment Period

4 years

First QC Date

January 26, 2010

Last Update Submit

April 29, 2015

Conditions

Gestational DiabetesGestational Diabetes MellitusDiabetes Mellitus, GestationalPregnancy-Induced DiabetesDiabetes, Pregnancy Induced

Keywords

Induced LabourExpectant ManagementC-section rateMaternal OutcomesNeonatal Outcomes

Outcome Measures

Primary Outcomes (1)

  • C-section rate

    1 minute after delivery

Secondary Outcomes (21)

  • Operative Vaginal Delivery

    1 minute after delivery

  • Perineal Tears or Episiotomy

    1 minute after delivery

  • Postpartum haemorrhage

    within 24 hours from delivery

  • Maternal Blood Transfusion

    until maternal discharge

  • Maternal Intensive Care Unit Admission

    until maternal discharge

  • +16 more secondary outcomes

Study Arms (2)

INDUCTION of LABOUR

EXPERIMENTAL

At enrollment patients assigned to the induction group will be admitted to the obstetric ward and will undergo induction of labour as described in the intervention section. Once patient's Bishop score exceeds 7 or regular contractions are diagnosed, patients will be transferred to the delivery ward for artificial rupture of membranes (ARM) or Oxytocin augmentation as indicated.

Other: INDUCTION of LABOUR

EXPECTANT MANAGEMENT

NO INTERVENTION

Patients enrolled in the conservative management arm will be followed up twice weekly for foetal wellbeing by Non-stress test and Biophysical profile. Patients will be followed up to 41+0 weeks. Patients, who will not deliver by this gestational age, will be admitted for labour induction (see the above protocol). Induction of labour will be offered when non-reassuring foetal status is suspected. All patients in the conservative arm will undergo foetal weight ultrasound estimation prior to induction. Patients with estimated foetal weight over 4000 gr will be offered a C-section.

Interventions

INDUCTION of LABOUROTHER

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.

INDUCTION of LABOUR

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Maternal age \> 18;
  • Singleton pregnancy in vertex presentation;
  • Gestational age between 38-39 weeks verified by LMP and first trimester ultrasound when available;
  • Women diagnosed with GDM in the current pregnancy \[Diagnosis will be based upon abnormal 50 Gr. GCT (\>140) followed by \>2 abnormal indices in the OGTT (according to C\&C criteria). Women with GCT\>200 mg/dl will undergo 100 gr OGTT as well\];
  • No other contraindications for vaginal delivery.

You may not qualify if:

  • Pre-gestational diabetes;
  • Prior C-section;
  • Suspected estimated fetal weight\> 4000 gr. at enrollment;
  • Any known contraindications for vaginal delivery;
  • Uncertain gestational age;
  • Non-reassuring fetal status necessitating immediate obstetrical intervention (prompt delivery/prompt C-section);
  • Maternal disease complicating pregnancy and necessitating delivery (e.g Severe PET);
  • Bishop score \>7 at enrollment;
  • Major fetal malformation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Helen Schneider's Hospital for Women - Rabin Medical Center

Petah Tikva, 49100, Israel

Location

I Ostetricia Spedali Civili

Brescia, 25100, Italy

Location

Department of Gynecology Perinatology and Human Reproduction

Florence, 50141, Italy

Location

Unità Operativa di Ostetricia e Ginecologia - Ospedale Buzzi

Milan, 20154, Italy

Location

Institute for Maternal and Child Health - IRCCS Burlo Garofolo

Trieste, 34100, Italy

Location

Dipartimento di Discipline Ginecologiche ed Ostetriche - Università di Torino

Turin, 10126, Italy

Location

Division Woman and Baby - UMC Utrecht/ Wilhelmina Children's Hospital

Utrecht, 3508 AB, Netherlands

Location

Department of ob/gyn, Division of perinatology - University Medical Centre

Ljubljana, SI-1000, Slovenia

Location

Department of Obstetrics and Gynecology - University of Colombo

Colombo, Colombo 08, Sri Lanka

Location

Related Publications (1)

  • Maso G, Alberico S, Wiesenfeld U, Ronfani L, Erenbourg A, Hadar E, Yogev Y, Hod M; GINEXMAL Study Cooperative Research Group. "GINEXMAL RCT: Induction of labour versus expectant management in gestational diabetes pregnancies". BMC Pregnancy Childbirth. 2011 Apr 20;11:31. doi: 10.1186/1471-2393-11-31.

    PMID: 21507262BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Labor, Induced

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Salvatore Alberico, MD

    Institute for Maternal and Child Health IRCCS Burlo Garofolo

    STUDY DIRECTOR

  • Moshe Hod, MD

    Helen Schneider's Hospital for Women - Rabin Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 26, 2010

First Posted

January 29, 2010

Study Start

March 1, 2010

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

April 30, 2015

Record last verified: 2015-04

Locations

IL(1)IT(5)NL(1)SL(1)SR(1)