Gestational Diabetes: Induction Versus Expectant Management of Labour
- Conditions
- Diabetes Mellitus, GestationalDiabetes, Pregnancy InducedGestational DiabetesGestational Diabetes MellitusPregnancy-Induced Diabetes
- Interventions
- Other: INDUCTION of LABOUR
- Registration Number
- NCT01058772
- Lead Sponsor
- IRCCS Burlo Garofolo
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 425
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description INDUCTION of LABOUR 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.
- Primary Outcome Measures
Name Time Method C-section rate 1 minute after delivery
- Secondary Outcome Measures
Name Time Method Shoulder Dystocia during delivery 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 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
Trial Locations
- Locations (9)
Helen Schneider's Hospital for Women - Rabin Medical Center
🇮🇱Petah-Tiqva, Israel
I Ostetricia Spedali Civili
🇮🇹Brescia, Italy
Department of Gynecology Perinatology and Human Reproduction
🇮🇹Florence, Italy
Unità Operativa di Ostetricia e Ginecologia - Ospedale Buzzi
🇮🇹Milan, Italy
Department of Obstetrics and Gynecology - University of Colombo
🇱🇰Colombo, Sri Lanka
Institute for Maternal and Child Health - IRCCS Burlo Garofolo
🇮🇹Trieste, Italy
Dipartimento di Discipline Ginecologiche ed Ostetriche - Università di Torino
🇮🇹Turin, Italy
Division Woman and Baby - UMC Utrecht/ Wilhelmina Children's Hospital
🇳🇱Utrecht, Netherlands
Department of ob/gyn, Division of perinatology - University Medical Centre
🇸🇮Ljubljana, Slovenia