Gestational Diabetes: Induction Versus Expectant Management of Labour (GINEXMAL)
|ClinicalTrials.gov Identifier: NCT01058772|
Recruitment Status : Completed
First Posted : January 29, 2010
Last Update Posted : April 30, 2015
|Condition or disease||Intervention/treatment||Phase|
|Gestational Diabetes Gestational Diabetes Mellitus Diabetes Mellitus, Gestational Pregnancy-Induced Diabetes Diabetes, Pregnancy Induced||Other: INDUCTION of LABOUR||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||425 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||GINEXMAL RCT: Induction of Labour Versus Expectant Management in Gestational Diabetes Pregnancies|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
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.
- C-section rate [ Time Frame: 1 minute after delivery ]
- Operative Vaginal Delivery [ Time Frame: 1 minute after delivery ]
- Perineal Tears or Episiotomy [ Time Frame: 1 minute after delivery ]
- Postpartum haemorrhage [ Time Frame: within 24 hours from delivery ]
- Maternal Blood Transfusion [ Time Frame: until maternal discharge ]
- Maternal Intensive Care Unit Admission [ Time Frame: until maternal discharge ]
- Neonatal Weight [ Time Frame: 10 minutes after delivery ]
- Neonatal Apgar score at 1', 5', 10' minutes [ Time Frame: 1, 5, 10 minutes after delivery ]
- Shoulder Dystocia [ Time Frame: during delivery ]
- Manoeuvres for Shoulder Dystocia [ Time Frame: during delivery ]
- Neonatal Intensive Care Unit Admission [ Time Frame: until neonatal discharge ]
- Arterial cord Ph inferior to 7.2 [ Time Frame: within 5 minutes from delivery ]
- Neonatal Hyperbilirubinemia [ Time Frame: until neonatal discharge ]
- Clinical and Biochemical Neonatal Hypoglycemia [ Time Frame: until neonatal discharge ]
- Neonatal Polycythemia [ Time Frame: until neonatal discharge ]
- Neonatal Birth Trauma [ Time Frame: 10 minute from delivery or until neonatal discharge ]
- Neonatal Respiratory Distress/Transient Tachypnea [ Time Frame: until neonatal discharge ]
- Neonatal Need for Respiratory Support [ Time Frame: until neonatal discharge ]
- Maternal death [ Time Frame: until neonatal discharge ]
- Perinatal Death [ Time Frame: until neonatal discharge ]
- Spontaneous/Instrumental third stage of labour [ Time Frame: within 1 hours from delivery ]
- Indication for Cesarean Section [ Time Frame: 1 minutes after delivery ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01058772
|Helen Schneider's Hospital for Women - Rabin Medical Center|
|Petah-Tiqva, Israel, 49100|
|I Ostetricia Spedali Civili|
|Brescia, Italy, 25100|
|Department of Gynecology Perinatology and Human Reproduction|
|Florence, Italy, 50141|
|Unità Operativa di Ostetricia e Ginecologia - Ospedale Buzzi|
|Milan, Italy, 20154|
|Institute for Maternal and Child Health - IRCCS Burlo Garofolo|
|Trieste, Italy, 34100|
|Dipartimento di Discipline Ginecologiche ed Ostetriche - Università di Torino|
|Turin, Italy, 10126|
|Division Woman and Baby - UMC Utrecht/ Wilhelmina Children's Hospital|
|Utrecht, Netherlands, 3508 AB|
|Department of ob/gyn, Division of perinatology - University Medical Centre|
|Ljubljana, Slovenia, SI-1000|
|Department of Obstetrics and Gynecology - University of Colombo|
|Colombo, Sri Lanka, Colombo 08|
|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|