Gestational Diabetes: Induction Versus Expectant Management of Labour (GINEXMAL)

April 29, 2015 updated by: Ronfani Luca, IRCCS Burlo Garofolo

GINEXMAL RCT: Induction of Labour Versus Expectant Management in Gestational Diabetes Pregnancies

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Gestational Diabetes Mellitus (GDM) is one of the most common complications of pregnancy and its incidence is estimated as around 7%. Babies born from women with GDM are significantly more exposed to perinatal risk. Furthermore in GDM pregnancies an increased C-section rate has been observed, mostly unjustified.

Strong evidence, based on prospective studies and randomized controlled trials, in favour or against the effectiveness and safeness of induction in women with GDM, are missing. The aim of the present study is to identify the best management for these women at term and provide evidence that could change the current clinical practice.

To reach this objective, 1760 eligible women will be recruited at 9 Teaching Hospitals (5 in Italy, 4 all over the world). Sample size has been estimated to demonstrate a difference between the two arms ≥ 6% (31% of C-section in the expectant group and 25% in the induction group; relative difference between the 2 groups equal to 20% in favor of induction; Kjos et al, 1993), considering an α error equal to 5% and 80% power.

Patients will be randomized to induction of labour (N=880) or expectant management (N=880). Data on maternal and neonatal outcomes will be collected at delivery and until maternal and neonatal discharge.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
425

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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
      • Petah-Tiqva, Israel, 49100
        • Helen Schneider's Hospital for Women - Rabin Medical Center
  • Italy
      • Brescia, Italy, 25100
        • I Ostetricia Spedali Civili
      • Florence, Italy, 50141
        • Department of Gynecology Perinatology and Human Reproduction
      • Milan, Italy, 20154
        • Unità Operativa di Ostetricia e Ginecologia - Ospedale Buzzi
      • Trieste, Italy, 34100
        • Institute for Maternal and Child Health - IRCCS Burlo Garofolo
      • Turin, Italy, 10126
        • Dipartimento di Discipline Ginecologiche ed Ostetriche - Università di Torino
  • Netherlands
      • Utrecht, Netherlands, 3508 AB
        • Division Woman and Baby - UMC Utrecht/ Wilhelmina Children's Hospital
  • Slovenia
      • Ljubljana, Slovenia, SI-1000
        • Department of ob/gyn, Division of perinatology - University Medical Centre
  • Sri Lanka
      • Colombo, Sri Lanka, Colombo 08
        • Department of Obstetrics and Gynecology - University of Colombo

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: INDUCTION of LABOUR

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
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.
NO_INTERVENTION: EXPECTANT MANAGEMENT

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
C-section rate
Time Frame: 1 minute after delivery
1 minute after delivery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Operative Vaginal Delivery
Time Frame: 1 minute after delivery
1 minute after delivery
Perineal Tears or Episiotomy
Time Frame: 1 minute after delivery
1 minute after delivery
Postpartum haemorrhage
Time Frame: within 24 hours from delivery
within 24 hours from delivery
Maternal Blood Transfusion
Time Frame: until maternal discharge
until maternal discharge
Maternal Intensive Care Unit Admission
Time Frame: until maternal discharge
until maternal discharge
Neonatal Weight
Time Frame: 10 minutes after delivery
10 minutes after delivery
Neonatal Apgar score at 1', 5', 10' minutes
Time Frame: 1, 5, 10 minutes after delivery
1, 5, 10 minutes after delivery
Shoulder Dystocia
Time Frame: during delivery
during delivery
Manoeuvres for Shoulder Dystocia
Time Frame: during delivery
during delivery
Neonatal Intensive Care Unit Admission
Time Frame: until neonatal discharge
until neonatal discharge
Arterial cord Ph inferior to 7.2
Time Frame: within 5 minutes from delivery
within 5 minutes from delivery
Neonatal Hyperbilirubinemia
Time Frame: until neonatal discharge
until neonatal discharge
Clinical and Biochemical Neonatal Hypoglycemia
Time Frame: until neonatal discharge
until neonatal discharge
Neonatal Polycythemia
Time Frame: until neonatal discharge
until neonatal discharge
Neonatal Birth Trauma
Time Frame: 10 minute from delivery or until neonatal discharge
10 minute from delivery or until neonatal discharge
Neonatal Respiratory Distress/Transient Tachypnea
Time Frame: until neonatal discharge
until neonatal discharge
Neonatal Need for Respiratory Support
Time Frame: until neonatal discharge
until neonatal discharge
Maternal death
Time Frame: until neonatal discharge
until neonatal discharge
Perinatal Death
Time Frame: until neonatal discharge
until neonatal discharge
Spontaneous/Instrumental third stage of labour
Time Frame: within 1 hours from delivery
within 1 hours from delivery
Indication for Cesarean Section
Time Frame: 1 minutes after delivery
1 minutes after delivery

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IRCCS Burlo Garofolo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: 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

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RC 22/09

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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