Gestational Diabetes: Induction Versus Expectant Management of Labour (GINEXMAL)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by IRCCS Burlo Garofolo.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
IRCCS Burlo Garofolo
ClinicalTrials.gov Identifier:
NCT01058772
First received: January 26, 2010
Last updated: August 31, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Gestational Diabetes
Gestational Diabetes Mellitus
Diabetes Mellitus, Gestational
Pregnancy-Induced Diabetes
Diabetes, Pregnancy Induced
Other: INDUCTION of LABOUR

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: GINEXMAL RCT: Induction of Labour Versus Expectant Management in Gestational Diabetes Pregnancies

Resource links provided by NLM:


Further study details as provided by IRCCS Burlo Garofolo:

Primary Outcome Measures:
  • C-section rate [ Time Frame: 1 minute after delivery ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 1760
Study Start Date: March 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

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.
No Intervention: EXPECTANT MANAGEMENT

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.


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01058772

Contacts
Contact: Luca Ronfani, MD 0039(0)403785 ext 401 ronfani@burlo.trieste.it
Contact: Anna Erenbourg, MD 0039(0)403785 ext 520 erenbourg@burlo.trieste.it

Locations
Israel
Helen Schneider's Hospital for Women - Rabin Medical Center Recruiting
Petah-Tiqva, Israel, 49100
Contact: Eran Hadar, MD    97239377400    dolgaldor@hotmail.com   
Contact: Yariv Yogev, MD    97239377400    yarivyogev@hotmail.com   
Principal Investigator: Moshe Hod, MD         
Italy
I Ostetricia Spedali Civili Not yet recruiting
Brescia, Italy, 25100
Contact: Sonia Zatti, MD    00390303995365    sonia_zatti@libero.it   
Contact: Andrea Lojacono, MD    00390303995365    lojacono@med.unibs.it   
Principal Investigator: Tiziana Frusca, MD         
Department of Gynecology Perinatology and Human Reproduction Not yet recruiting
Florence, Italy, 50141
Contact: Federico Mecacci, MD    00393482605661    mecacci@tin.it   
Contact: Elisabetta Martini, MD    00393478598947    Martini_Elisabetta@libero.it   
Principal Investigator: Giorgio Mello, MD         
Unità Operativa di Ostetricia e Ginecologia - Ospedale Buzzi Not yet recruiting
Milan, Italy, 20154
Contact: Enrico Ferrazzi, MD       enrico.ferrazzi@unimi.it   
Principal Investigator: Enrico Ferrazzi, MD         
Institute for Maternal and Child Health - IRCCS Burlo Garofolo Recruiting
Trieste, Italy, 34100
Contact: Salvatore Alberico, MD    0039(0)403785 ext 303    alberico@burlo.trieste.it   
Contact: Uri Wiesenfeld, MD    0039(0)403785 ext 253    wiesenfe@burlo.trieste.it   
Principal Investigator: Salvatore Alberico, MD         
Sub-Investigator: Gianpaolo Maso, MD         
Dipartimento di Discipline Ginecologiche ed Ostetriche - Università di Torino Not yet recruiting
Turin, Italy, 10126
Contact: Ilenia Cotrino, MD    0039(0)113131750    lunile@libero.it   
Contact: Manuela Mensa, MD    0039(0)113131822    mela.manu@gmail.com   
Principal Investigator: Guido Menato, MD         
Netherlands
Division Woman and Baby - UMC Utrecht/ Wilhelmina Children's Hospital Not yet recruiting
Utrecht, Netherlands, 3508 AB
Contact: G.H.A. Visser, MD    0031(0)887556421    G.H.A.Visser@umcutrecht.nl   
Principal Investigator: G.H.A. Visser, MD         
Slovenia
Department of ob/gyn, Division of perinatology - University Medical Centre Not yet recruiting
Ljubljana, Slovenia, SI-1000
Contact: Alenka Sketelj, MD    0038615226166    sketeli@siol.net   
Contact: Marjeta Tomazic, MD    0038615222782    marjeta.tomazic@kclj.si   
Principal Investigator: Lili Steblovnik, MD         
Sri Lanka
Department of Obstetrics and Gynecology - University of Colombo Not yet recruiting
Colombo, Sri Lanka, Colombo 08
Contact: Senanayake Hemantha, MD    0094714762176    senanayakeh@gmail.com   
Principal Investigator: Senanayake Hemantha, MD         
Sponsors and Collaborators
IRCCS Burlo Garofolo
Investigators
Study Director: Salvatore Alberico, MD Institute for Maternal and Child Health - IRCCS Burlo Garofolo
Study Director: Moshe Hod, MD Helen Schneider's Hospital for Women - Rabin Medical Center
  More Information

Publications:
Responsible Party: Salvatore Alberico, Institute for Maternal and Child Health - IRCCS Burlo Garofolo
ClinicalTrials.gov Identifier: NCT01058772     History of Changes
Other Study ID Numbers: RC 22/09
Study First Received: January 26, 2010
Last Updated: August 31, 2011
Health Authority: Italy: Ministry of Health

Keywords provided by IRCCS Burlo Garofolo:
Induced Labour
Expectant Management
C-section rate
Maternal Outcomes
Neonatal Outcomes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on April 16, 2014