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CTRI Number  CTRI/2018/08/015553 [Registered on: 31/08/2018] Trial Registered Retrospectively
Last Modified On: 27/08/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparing drug versus drug with catheter in low risk first time pregnant mothers for labor induction 
Scientific Title of Study   Misoprostol with Foleys catheter versus Misoprostol alone for induction of labor in term primigravidas - a prospective randomized coitrol trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Neeraj Kulkarni 
Designation  Post Graduate 
Affiliation  Christian Medical College 
Address  Department of Obstetrics and Gynaecology unit - 3

Vellore
TAMIL NADU
632004
India 
Phone  9566804173  
Fax    
Email  drneerajkulkarni@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jessie Lionel 
Designation  Professor 
Affiliation  CMC Vellore 
Address  Department of Obstetrics and Gynaecology Unit I Christian Medical College

Vellore
TAMIL NADU
632004
India 
Phone  9566804173  
Fax    
Email  jessielionel@cmcvellore.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Jessie Lionel 
Designation  Professor 
Affiliation  CMC Vellore 
Address  Department of Obstetrics and Gynaecology unit I Christian Medical College

Vellore
TAMIL NADU
632004
India 
Phone  9566804173  
Fax  9566804173  
Email  jessielionel@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
Department of Obstetrics and Gynaecology unit I Christian Medical College Vellore Tamil Nadu 632004 
 
Primary Sponsor  
Name  CMC vellore 
Address  CMC Vellore Tamil Nadu 632004 
Type of Sponsor  Research institution 
 
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 Jessie Lionel  Christian Medical College  Department of Obstetrics and Gynaecology unit I
Vellore
TAMIL NADU 
9566804173

jessielionel@cmcvellore.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Christian Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Pregnant women who are planned for induction of labor,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Misoprostol  PV PGE1 Q4h for 3 doses 
Comparator Agent  misoprostol with foleys   Misoprostol versus misoprostol with foleys comparing term primi gravida whether interval to delivery is reduced 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1 Primigravida
2 37 completed weeks to 40+6 weeks of gestation
3 Low risk pregnancy
4 Singleton, cephalic presentation, live fetes
5 Intact membranes
6 Bishops Score <6 (not in labour)
• Reactuve preinduction CTG 
 
ExclusionCriteria 
Details  1 Multigravida
2 Bishops Score >6
3 High Risk Pregnancy
4 Rupture of membranes
5 Maternal fever
6 Non vertex presentation
7 Non reassuring CTG
8 Reinduction (previously unsuccessful induction of labour)
9 Allergy to Misoprostol/ latex
10 Previous LSCS/myomectomy 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Induction to delivery interval  once 
 
Secondary Outcome  
Outcome  TimePoints 
Rate of vaginal delivery
Rate of primary LSCS
Incidence of Meconium stained liquor Uterine tachysystole with CTG changes Endomyometritis
Need for Terbutaline
Chorioamnionitis
Asphyxia (Cord pH , 7.2, low APGAR 5 and 7 )
Atonic PPH
NICU admission
Endomyometritis
 
All these outcomes will be assessed at the time of delivery and upto 6 weeks post partum 
 
Target Sample Size   Total Sample Size="608"
Sample Size from India="608" 
Final Enrollment numbers achieved (Total)= "589"
Final Enrollment numbers achieved (India)="589" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/09/2015 
Date of Study Completion (India) 02/04/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
Months="6"
Days="2" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   not yet planned 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Induction of labour is the stimulation of uterine contractions before the spontaneous

 

onset of labour, in the presence or absence of membranes (1).

 

Induction of labour is indicated in cases where continuation of pregnancy poses more

 

risk than benefit to the mother or/and fetus. Some examples of these situations are,

 

rupture of membranes before the start of uterine contractions, oligohydramnios,

 

gestational hypertension, intrauterine growth restriction, maternal indications such as

 

diabetes mellitus/ chronic hypertension (2). Easy availability of ripening agents, and

 

patient  request also play an important role in increasing rates of induction of labour

 

(3).  Electively inducing labour for convenience to the obstetricians schedule has also

 

been recognized as a major contributing factor (4).

 

 

Induction of labour at term: Continuation of pregnancy beyond 42 weeks is

 

associated with complications to the mother and the fetus.  A Cochrane review studied

 

22 trials that induced labour between 37 and 42 weeks of gestation, compared to

 

waiting for spontaneous labour  (5). It was found that earlier induction resulted in

 

fewer perinatal deaths, less meconium aspiration and fewer caesareans than the policy

 

of waiting.  A systematic review by Caughey et al which included 11 randomised

 

control trials suggested that elective induction of labour after 41 weeks resulted in a

 

decreased risk for caesarean delivery and meconium stained amniotic fluid (6).

 

 

Prevalence of Induction of Labour: Induction rates seem to have increased in the

 

last decade. A study done in the US showed that the rate of induction of labour has

 

increased nationwide from 9.5% to 19.4% between the years 1990 and 1998 (3).

 

Increased rates of medically indicated inductions did not contribute to this rise as

 

much as marginally indicated, or elective inductions. These contribute to at least half

 

of all inductions, and induction of labour in nulliparas with an unfavourable cervix

 

results in rising rates of caesarean sections (7).

 

A national survey was done in the USA by Childhood Connection to ascertain the

 

experiences of women during pregnancy and labour (8) . 2400 women completed a

 

detailed online questionnaire. 41% of these women underwent induction of labour.

 

The most common rationale given to these mothers for inducing labour was that the

 

baby was overdue (18%), and a maternal health problem that required a quick delivery

 

(18%).

 

 

In Christian Medical College, Vellore, incidence of induction of labour whenever

indicated, is about 15- 20%. The rate of primary LSCS is about 18-24%, failed

induction accounting for 6-10% of cases 
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