Gestational Diabetes: Induction Versus Expectant Management of Labour

Study Overview
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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.

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.

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

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

Intervention / Treatment
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* Other: INDUCTION of LABOUR


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INDUCTION of LABOUR<br>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<br>* 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.<br>|
| No Intervention: EXPECTANT MANAGEMENT<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-section rate |  | 1 minute after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Neonatal Weight |  | 10 minutes after delivery | 
| Neonatal Apgar score at 1', 5', 10' minutes |  | 1, 5, 10 minutes after delivery | 
| Shoulder Dystocia |  | during delivery | 
| Manoeuvres for Shoulder Dystocia |  | during delivery | 
| Neonatal Intensive Care Unit Admission |  | until neonatal discharge | 
| Arterial cord Ph inferior to 7.2 |  | within 5 minutes from delivery | 
| Neonatal Hyperbilirubinemia |  | until neonatal discharge | 
| Clinical and Biochemical Neonatal Hypoglycemia |  | until neonatal discharge | 
| Neonatal Polycythemia |  | until neonatal discharge | 
| Neonatal Birth Trauma |  | 10 minute from delivery or until neonatal discharge | 
| Neonatal Respiratory Distress/Transient Tachypnea |  | until neonatal discharge | 
| Neonatal Need for Respiratory Support |  | until neonatal discharge | 
| Maternal death |  | until neonatal discharge | 
| Perinatal Death |  | until neonatal discharge | 
| Spontaneous/Instrumental third stage of labour |  | within 1 hours from delivery | 
| Indication for Cesarean Section |  | 1 minutes after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Induced Labour, Expectant Management, C-section rate, Maternal Outcomes, Neonatal Outcomes