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CTRI Number  CTRI/2011/12/002290 [Registered on: 26/12/2011] Trial Registered Retrospectively
Last Modified On: 21/12/2011
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To understand whether in women diagnosed with gestational diabetes well controlled on diet therapy at term (39-40 gestational weeks) would be better to induce labour or expect the spontaneous onset of labour 
Scientific Title of Study   Gestational diabetes well controlled on medical nutritional therapy: a randomized trial of active induction of labour compared with expectant management 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Phijam Dhaneshwor 
Designation  Post graduate registrar 
Affiliation   
Address  CMC Hospital, Vellore 632004

Vellore
TAMIL NADU
632004
India 
Phone  0416-228-3399  
Fax    
Email  dfizams@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Annie Regi 
Designation  Head of Unit, Obstetrics and gynaecology Unit III 
Affiliation  Dept. of Obstetrics and Gynecology, CMC Hospital, Vellore 
Address  Dept. of Obstetrics and Gynecology, CMC Hospital, Vellore 632004

Vellore
TAMIL NADU
632004
India 
Phone  0416-228-3399  
Fax    
Email  og3@cmcvellore.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Phijam Dhaneshwor 
Designation  Post graduate registrar 
Affiliation   
Address  CMC Hospital, Vellore 632004

Vellore
TAMIL NADU
632004
India 
Phone  0416-228-3399  
Fax    
Email  dfizams@gmail.com  
 
Source of Monetary or Material Support  
Christian Medical College, Vellore 
 
Primary Sponsor  
Name  Institutional Research Board CMC Vellore 
Address  CMC Hospital, Vellore 632004 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Phijam Dhaneshwor  CMC Hospital, Vellore  Dept. of Obstetrics and Gynecology, CMC Hospital, Vellore 632004, Tel no: 0416-228-3399
Vellore
TAMIL NADU 		 04162283399

dfizams@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board, CMC, Vellore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Gestational Diabetes Mellitus well controlled on Medical Nutritional Therapy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Expectant management  Expectant group – For those allocated to expectant group, they will be followed up until delivery, with AFI (Amniotic fluid index) and NST (Non stress test) twice a week. In absence of spontaneous delivery, labour will be induced at 40+6 weeks. In presence of non-reassuring foetal wellbeing at one of the follow-ups, she will immediately be offered labour induction. 
Intervention  Induction of labour  Induction group – For those in the induction group arm, cervical ripening will be done with Misoprostol (25 mcg every 6th hourly for 2 doses) as is the routine for induction of labour in our hospital. A 3rd dose will be used if the cervix is still unfavourable and NST is reactive. If cervix remains unfavourable after 3 doses, patient may be re-induced after 2-3 days as situation warrants or as per the parent treating unit protocol (PGE1 25 mcg Q6h 2 dose). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  •Maternal age ≥ 18 years
•Willing for delivery at CMC, Vellore
•Singleton pregnancy in vertex presentation
•Gestational age between 39+ and 40 weeks, by LMP sure of dates or by early scan
•Women diagnosed with GDM on diet therapy well controlled (AC <95, PC 1 hr. <130, 2 hr. <140) in the present pregnancy
•No contraindications to vaginal delivery
 
 
ExclusionCriteria 
Details  •Pregestational diabetes
•GDM diagnosed elsewhere
•GDM diagnosis not based on IADPGS recommendation
•GDM on OHA, Insulin or not under control(AC >95, PC 1 hr. >130, 2 hr. >140)
•Women not willing for delivery at CMC, Vellore
•Prior C-section
•Suspected estimated fetal weight > 3.5 kg or < 2.5 kg at enrolment
•Any known contraindications to vaginal delivery
•Uncertain gestational age
•Non reassuring fetal wellbeing necessitating delivery
•Maternal pregnancy-related disease necessitating delivery
•Known fetal anomaly
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Caesarean section  At the time of delivery 
 
Secondary Outcome  
Outcome  TimePoints 
Maternal
•Gestational age
•Mode of delivery
•Presence of perineal tears
•Postpartum hemorrhage
Fetal
•The occurrence of shoulder dystocia
•The eventual maneuvers
•Newborns birth weight
•Apgar score
•Arterial cord pH 7.0
 		 at time of delivery 
Maternal
•Need for maternal blood transfusion
•Maternal or neonatal intensive care unit admission, duration and diagnosis
•Maternal and perinatal death
•Prevalence of DM type II at 6 weeks postpartum
Neonatal
•Neonatal birth trauma
•Neonatal respiratory distress
•Neonatal need for respiratory support
•Neonatal hyperbilirubinemia
•Neonatal polycythemia
•Neonatal hypoglycemia  		 at the time of discharge 
 
Target Sample Size   Total Sample Size="220"
Sample Size from India="220" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   17/10/2011 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

GDM is one of the most common complications of pregnancy and its incidence is estimated at 7% (1).  Among women affected by GDM, an increased rate of C-section has been observed (2)(3). Expectant monitoring could determine an increase in macrosomic fetuses’ incidence, leading to a higher C-section rate. Although induction of labour could prevent fetal macrosomia and its consequences, its performance is thought to be possibly related to an enhancement in C-section and instrumental vaginal delivery rates (4).

Strong evidence, based on adequately designed prospective studies and randomized controlled trials, in favour or against the effectiveness and safeness of induction in women with GDM are missing (1) (5). In light of this clinical situation, randomized controlled trial comparing induction of labour at term to careful expectant monitoring is needed

The present trial will provide evidence as to whether or not, in women affected by gestational Diabetes on MNT, expectant management till 41 weeks is an effective management to ameliorate maternal and neonatal outcomes. 

 
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