Gestational Diabetes: Induction Versus Expectant Management of Labour

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

425 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2014-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

INDUCTION of LABOUR

Intervention Type OTHER

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No