Clinical trial NCT01058772: Gestational Diabetes: Induction Versus Expectant Management of Labour
Official title: GINEXMAL RCT: Induction of Labour Versus Expectant Management in Gestational Diabetes Pregnancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Gestational Diabetes Mellitus
Diabetes Mellitus, Gestational
Pregnancy-Induced Diabetes
Diabetes, Pregnancy Induced
Keywords: Induced Labour
Expectant Management
C-section rate
Maternal Outcomes
Neonatal Outcomes
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2010-01-29
Enrollment: 425
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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.

Primary outcomes:
measure: C-section rate
timeFrame: 1 minute after delivery
Secondary outcomes:
measure: Operative Vaginal Delivery
timeFrame: 1 minute after delivery
measure: Perineal Tears or Episiotomy
timeFrame: 1 minute after delivery
measure: Postpartum haemorrhage
timeFrame: within 24 hours from delivery
measure: Maternal Blood Transfusion
timeFrame: until maternal discharge
measure: Maternal Intensive Care Unit Admission
timeFrame: until maternal discharge
measure: Neonatal Weight
timeFrame: 10 minutes after delivery
measure: Neonatal Apgar score at 1', 5', 10' minutes
timeFrame: 1, 5, 10 minutes after delivery
measure: Shoulder Dystocia
timeFrame: during delivery
measure: Manoeuvres for Shoulder Dystocia
timeFrame: during delivery
measure: Neonatal Intensive Care Unit Admission
timeFrame: until neonatal discharge
measure: Arterial cord Ph inferior to 7.2
timeFrame: within 5 minutes from delivery
measure: Neonatal Hyperbilirubinemia
timeFrame: until neonatal discharge
measure: Clinical and Biochemical Neonatal Hypoglycemia
timeFrame: until neonatal discharge
measure: Neonatal Polycythemia
timeFrame: until neonatal discharge
measure: Neonatal Birth Trauma
timeFrame: 10 minute from delivery or until neonatal discharge
measure: Neonatal Respiratory Distress/Transient Tachypnea
timeFrame: until neonatal discharge
measure: Neonatal Need for Respiratory Support
timeFrame: until neonatal discharge
measure: Maternal death
timeFrame: until neonatal discharge
measure: Perinatal Death
timeFrame: until neonatal discharge
measure: Spontaneous/Instrumental third stage of labour
timeFrame: within 1 hours from delivery
measure: Indication for Cesarean Section
timeFrame: 1 minutes after delivery
Other outcomes:
Locations:
city: Petah-Tiqva
country: Israel
facility: Helen Schneider's Hospital for Women - Rabin Medical Center
city: Brescia
country: Italy
facility: I Ostetricia Spedali Civili
city: Florence
country: Italy
facility: Department of Gynecology Perinatology and Human Reproduction
city: Milan
country: Italy
facility: Unità Operativa di Ostetricia e Ginecologia - Ospedale Buzzi
city: Trieste
country: Italy
facility: Institute for Maternal and Child Health - IRCCS Burlo Garofolo
city: Turin
country: Italy
facility: Dipartimento di Discipline Ginecologiche ed Ostetriche - Università di Torino
city: Utrecht
country: Netherlands
facility: Division Woman and Baby - UMC Utrecht/ Wilhelmina Children's Hospital
city: Ljubljana
country: Slovenia
facility: Department of ob/gyn, Division of perinatology - University Medical Centre
city: Colombo
country: Sri Lanka
facility: Department of Obstetrics and Gynecology - University of Colombo
Study officials:
affiliation: Institute for Maternal and Child Health IRCCS Burlo Garofolo
name: Salvatore Alberico, MD
role: STUDY_DIRECTOR
affiliation: Helen Schneider's Hospital for Women - Rabin Medical Center
name: Moshe Hod, MD
role: STUDY_DIRECTOR
References:
citation: 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.