Gestational Diabetes: Induction Versus Expectant Management of Labour

Gestational Diabetes Clinical Trial

— GINEXMAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01058772
• Other study ID #: RC 22/09
• Status: Completed
• Phase: N/A
• First received: January 26, 2010
• Last updated: April 29, 2015
• Start date: March 2010
• Est. completion date: March 2014

Study information

• Verified date: April 2015
• Source: IRCCS Burlo Garofolo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 425
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Israel	Helen Schneider's Hospital for Women - Rabin Medical Center	Petah-Tiqva
Italy	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	Institute for Maternal and Child Health - IRCCS Burlo Garofolo	Trieste
Italy	Dipartimento di Discipline Ginecologiche ed Ostetriche - Università di Torino	Turin
Netherlands	Division Woman and Baby - UMC Utrecht/ Wilhelmina Children's Hospital	Utrecht
Slovenia	Department of ob/gyn, Division of perinatology - University Medical Centre	Ljubljana
Sri Lanka	Department of Obstetrics and Gynecology - University of Colombo	Colombo

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Burlo Garofolo

Countries where clinical trial is conducted

Israel,  Italy,  Netherlands,  Slovenia,  Sri Lanka, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C-section rate		1 minute after delivery	Yes
Secondary	Operative Vaginal Delivery		1 minute after delivery	Yes
Secondary	Perineal Tears or Episiotomy		1 minute after delivery	Yes
Secondary	Postpartum haemorrhage		within 24 hours from delivery	Yes
Secondary	Maternal Blood Transfusion		until maternal discharge	Yes
Secondary	Maternal Intensive Care Unit Admission		until maternal discharge	Yes
Secondary	Neonatal Weight		10 minutes after delivery	Yes
Secondary	Neonatal Apgar score at 1', 5', 10' minutes		1, 5, 10 minutes after delivery	Yes
Secondary	Shoulder Dystocia		during delivery	Yes
Secondary	Manoeuvres for Shoulder Dystocia		during delivery	Yes
Secondary	Neonatal Intensive Care Unit Admission		until neonatal discharge	Yes
Secondary	Arterial cord Ph inferior to 7.2		within 5 minutes from delivery	Yes
Secondary	Neonatal Hyperbilirubinemia		until neonatal discharge	Yes
Secondary	Clinical and Biochemical Neonatal Hypoglycemia		until neonatal discharge	Yes
Secondary	Neonatal Polycythemia		until neonatal discharge	Yes
Secondary	Neonatal Birth Trauma		10 minute from delivery or until neonatal discharge	Yes
Secondary	Neonatal Respiratory Distress/Transient Tachypnea		until neonatal discharge	Yes
Secondary	Neonatal Need for Respiratory Support		until neonatal discharge	Yes
Secondary	Maternal death		until neonatal discharge	Yes
Secondary	Perinatal Death		until neonatal discharge	Yes
Secondary	Spontaneous/Instrumental third stage of labour		within 1 hours from delivery	Yes
Secondary	Indication for Cesarean Section		1 minutes after delivery	No