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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01058772
Other study ID # RC 22/09
Secondary ID
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


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
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