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CTRI Number  CTRI/2019/09/021130 [Registered on: 09/09/2019] Trial Registered Prospectively
Last Modified On: 15/08/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   "SAFETY AND EFFICACY OF ORAL AND VAGINAL MISOPROSTOL FOR INDUCTION OF LABOUR IN TERM PREGNANCIES”- A RANDOMISED CONTROLLED TRIAL IN A TERTIARY HEALTH CENTRE 
Scientific Title of Study   "SAFETY AND EFFICACY OF ORAL V/S VAGINALLY ADMINISTERED MISOPROSTOL FOR INDUCTION OF LABOUR IN TERM PREGNANCIES” - A RANDOMISED CONTROLLED TRIAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DRRESHMA RAJENDRAN 
Designation  post graduate resident 
Affiliation  MOSC MEDICAL COLLEGE 
Address  MOSC MEDICAL COLLEGE KOLENCHERY KERALA 682311

Ernakulam
KERALA
682311
India 
Phone  9995782050  
Fax    
Email  dr.reshmaraj22@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DRANNIE SOMAN 
Designation  HEAD OF DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY 
Affiliation  MOSC MEDICAL COLLEGE 
Address  MOSC MEDICAL COLLEGE KOLENCHERY KERALA 682311

Ernakulam
KERALA
682311
India 
Phone  9995782050  
Fax    
Email  aniesoman@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DRRESHMA RAJENDRAN 
Designation  post graduate resident 
Affiliation  MOSC MEDICAL COLLEGE 
Address  MOSC MEDICAL COLLEGE KOLENCHERY KERALA 682311

Ernakulam
KERALA
682311
India 
Phone  9995782050  
Fax    
Email  dr.reshmaraj22@gmail.com  
 
Source of Monetary or Material Support  
in patient and out patients, Mosc medical college Kolenchery 
 
Primary Sponsor  
Name  MOSC MEDICAL COLLEGEKOLENCHERY 
Address  MOSC MEDICAL COLLEGE,KOLENCHERY 682311 
Type of Sponsor  Private medical college 
 
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 
Dhanya paul  malankara orthodox syrian church medical college,kolenchery  DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY HOSPITAL COMPLEX MOSC MEDICAL COLLEGE, KOLENCHERRY 682311
Ernakulam
KERALA 
9495510265

dhanyapaulmary@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MOSC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O481||Prolonged pregnancy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ORAL MISOPROSTOL  25mcg Q2h x total 5 doses for 1 day SAFETY AND EFFICACY OF ORAL AND VAGINALLY ADMINISTERED MISOPROSTOL FOR INDUCTION OF LABOUR IN TERM PREGNANCIES 
Comparator Agent  VAGINAL MISORPOSTOL  25mcg Q4h x total 4 doses x 1 day SAFETY AND EFFICACY OF ORAL AND VAGINALLY ADMINISTERED MISOPROSTOL FOR INDUCTION OF LABOUR IN TERM PREGNANCIES 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Nulliparous and Multiparous women at term(37-42 completed weeks of gestation with first trimester ultrasound confirmed dates),with a singleton fetus of Cephalic presentation with :
Clinically adequate pelvis
Reassuring fetal heart tracing,
,Modified bishop’s score of less than 6
[1]Gestational diabetes mellitus,
[2] gestational hypertension,
[3]past date,
[4]oligohydramnios,
[5]Premature rupture of membranes[<6hours]
Are eligible for this trial 
 
ExclusionCriteria 
Details  All patients with [1]severe systemic illnesses like uncontrolled diabetes mellitus, severe pre-eclampsia, cardiac, renal or hepatic disease,
[2] IUGR,
[3]intrauterine deaths
[4]hypersensitivity to misoprostol or any prostaglandin analogue
[5] Patients with any contraindication to induction and vaginal delivery, e.g. cephalopelvic disproportion, malpresentation, fetal compromise, non reassuring fetal heart rate pattern, previous scar and ante partum haemorrhage.
[6] Patients who are not willing to participate in this study  
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Outcome variables. - Primary Caesarean for fetal distress,   1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Induction delivery interval
Maternal and perinatal outcome 
2weeks 
 
Target Sample Size   Total Sample Size="154"
Sample Size from India="154" 
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 2 
Date of First Enrollment (India)   19/09/2019 
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)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  
NONE YET 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  
Induction of labour implies stimulation of contractions before the spontaneous onset of labour, with or without ruptured membranes.[1].According to ACOG 2014[2],the risks and benefits of induction of labour were studied on caesarean section rate and trials showed no significant difference .Recent studies[3]- variation .i.e oral misoprostol for induction has comparatively decreased the incidence of Primary caesarean section for fetal distress. Primary caesarean which is a caesarean section done for the first time in pregnant woman.
Prostaglandins has been found to have a major role in cervical ripening and making it favourable for a vaginal delivery. Among them, Misoprostol [Synthetic PGE1 analogue] is commonly used. It is Stable at room temperature, Relatively inexpensive ,can be given via several routes -oral, vaginal, sublingual ,buccal, rectal. Misoprostol has a potential risk for hyperstimulation, which is defined as occurrence of uterine contraction lasting for >60secs ,OR >4 contractions in a 10 minute period regardless the state of the fetus. Therefore, it is necessary to be administered in titrated doses so that the risk can be reduced .This is the reason for inclusion of oral misoprostol as one of the recommended induction agents in the WHO EXPERT committee-Labour guidelines in 2011.
 
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