Gestational Diabetes: Induction Versus Expectant Management of Labour (GINEXMAL)
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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 |
- C-section rate [ Time Frame: 1 minute after delivery ] [ Designated as safety issue: Yes ]
- 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 |
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| 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 |
| 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 | |
| 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 May 23, 2013