Gestational DiabetesGINEXMALNCT01058772
Gestational Diabetes: Induction Versus Expectant Management of Labour
A study testing INDUCTION of LABOUR in people with Gestational Diabetes and Gestational Diabetes Mellitus, run by IRCCS Burlo Garofolo at 9 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes, Gestational Diabetes Mellitus, Diabetes Mellitus, Gestational
- What is being tested?
- INDUCTION of LABOUR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 425 participants
- Where
- 9 sitesin 5 countries
- Study dates
- Mar 2010to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
Show all 9Show fewer
- Maternal disease complicating pregnancy and necessitating delivery (e.g Severe PET);
- Bishop score >7 at enrollment;
- Major fetal malformation.
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
Italy5 sites
I Ostetricia Spedali Civili
Brescia, 25100
Department of Gynecology Perinatology and Human Reproduction
Florence, 50141
Unità Operativa di Ostetricia e Ginecologia - Ospedale Buzzi
Milan, 20154
Institute for Maternal and Child Health - IRCCS Burlo Garofolo
Trieste, 34100
Dipartimento di Discipline Ginecologiche ed Ostetriche - Università di Torino
Turin, 10126
Israel1 site
Helen Schneider's Hospital for Women - Rabin Medical Center
Petah Tikva, 49100
Netherlands1 site
Division Woman and Baby - UMC Utrecht/ Wilhelmina Children's Hospital
Utrecht, 3508 AB
Slovenia1 site
Department of ob/gyn, Division of perinatology - University Medical Centre
Ljubljana, SI-1000
Sri Lanka1 site
Department of Obstetrics and Gynecology - University of Colombo
Colombo, Colombo 08
About this study
Official title: GINEXMAL RCT: Induction of Labour Versus Expectant Management in Gestational Diabetes Pregnancies
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.
Read the 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.
- Conditions
- Gestational Diabetes, Gestational Diabetes Mellitus, Diabetes Mellitus, Gestational, Pregnancy-Induced Diabetes, Diabetes, Pregnancy Induced
- Being tested
- INDUCTION of LABOUR
- Keywords
- Induced Labour, Expectant Management, C-section rate, Maternal Outcomes, Neonatal Outcomes
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INDUCTION of LABOUROther
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.
| Study group | Role | What they receive |
|---|---|---|
| INDUCTION of LABOUR | Experimental | 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. Receives: Other: INDUCTION of LABOUR |
| EXPECTANT MANAGEMENT | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-section rate
Measured: 1 minute after delivery
Secondary outcomes (21)
Operative Vaginal Delivery
Measured: 1 minute after delivery
Perineal Tears or Episiotomy
Measured: 1 minute after delivery
Postpartum haemorrhage
Measured: within 24 hours from delivery
Maternal Blood Transfusion
Measured: until maternal discharge
Maternal Intensive Care Unit Admission
Measured: until maternal discharge
Neonatal Weight
Measured: 10 minutes after delivery
Neonatal Apgar score at 1', 5', 10' minutes
Measured: 1, 5, 10 minutes after delivery
Shoulder Dystocia
Measured: during delivery
Manoeuvres for Shoulder Dystocia
Measured: during delivery
Neonatal Intensive Care Unit Admission
Measured: until neonatal discharge
Arterial cord Ph inferior to 7.2
Measured: within 5 minutes from delivery
Neonatal Hyperbilirubinemia
Measured: until neonatal discharge
Clinical and Biochemical Neonatal Hypoglycemia
Measured: until neonatal discharge
Neonatal Polycythemia
Measured: until neonatal discharge
Neonatal Birth Trauma
Measured: 10 minute from delivery or until neonatal discharge
Neonatal Respiratory Distress/Transient Tachypnea
Measured: until neonatal discharge
Neonatal Need for Respiratory Support
Measured: until neonatal discharge
Maternal death
Measured: until neonatal discharge
Perinatal Death
Measured: until neonatal discharge
Spontaneous/Instrumental third stage of labour
Measured: within 1 hours from delivery
Indication for Cesarean Section
Measured: 1 minutes after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 425 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronfani Luca, IRCCS Burlo Garofolo
- Investigators
- Salvatore Alberico, MD, Study director, Institute for Maternal and Child Health IRCCS Burlo GarofoloMoshe Hod, MD, Study director, Helen Schneider's Hospital for Women - Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01058772
- Sponsor's protocol ID
- RC 22/09
- Acronym
- GINEXMAL
- Status last verified
- Apr 2015
- First submitted
- 26 Jan 2010
- Last updated
- 30 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21507262
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GINEXMAL RCT: Induction of Labour Versus Expectant Management in Gestational Diabetes Pregnancies
- ClinicalTrials.gov ID
- NCT01058772
- Acronym / sponsor ID
- GINEXMAL / RC 22/09
- Conditions
- Gestational Diabetes, Gestational Diabetes Mellitus, Diabetes Mellitus, Gestational, Pregnancy-Induced Diabetes, Diabetes, Pregnancy Induced
- Keywords
- Induced Labour, Expectant Management, C-section rate, Maternal Outcomes, Neonatal Outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 29 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INDUCTION of LABOUR | Experimental | Other: INDUCTION of LABOURAt 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. |
| EXPECTANT MANAGEMENT | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- Pre-gestational diabetes;
- Prior C-section;
- Suspected estimated fetal weight> 4000 gr. at enrollment;
- Any known contraindications for vaginal delivery;
- Uncertain gestational age;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INDUCTION of LABOURInduction 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. | Other | INDUCTION of LABOUR |
Primary outcome
C-section rate
Time frame: 1 minute after delivery
21 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2015.
- Background: PubMed 21507262Maso 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salvatore Alberico, MD study director
Institute for Maternal and Child Health IRCCS Burlo Garofolo
Moshe Hod, MD study director
Helen Schneider's Hospital for Women - Rabin Medical Center
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INDUCTION of LABOUR in people with Gestational Diabetes and Gestational Diabetes Mellitus, run by IRCCS Burlo Garofolo at 9 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Italy, Israel, Netherlands, Slovenia, Sri Lanka. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C-section rate (time frame: 1 minute after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01058772, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2015.