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CTRI Number  CTRI/2025/03/082272 [Registered on: 13/03/2025] Trial Registered Prospectively
Last Modified On: 06/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device
Surgical/Anesthesia
Other (Specify) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of efficacy of two drugs induction of labour 
Scientific Title of Study   Comparison of efficacy of oral misoprost solution versus vaginal misoprost tablets for induction of labour 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Laxmi Gupta 
Designation  Junior Resident 
Affiliation  King Georges Medical University Lucknow 
Address  Junior Resident, Department of Obstetrics and Gynaecology Queen Mary Hospital
King Georges Medical University Shahmina Road Lucknow
Lucknow
UTTAR PRADESH
226003
India 
Phone  7839690484  
Fax    
Email  drlaxmigupta2024@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manju Lata Verma 
Designation  Professor 
Affiliation  King Georges Medical University Lucknow 
Address  Professor Department of Obstetrics and Gynaecology Queen Mary Hospital
King Georges Medical University Shahmina Road Lucknow
Lucknow
UTTAR PRADESH
226003
India 
Phone  9721250092  
Fax    
Email  gaganmlv@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Manju Lata Verma 
Designation  Professor 
Affiliation  King Georges Medical University Lucknow 
Address  Professor Department of Obstetrics and Gynaecology Queen Mary Hospital
King Georges Medical University Shahmina Road Lucknow
Lucknow
UTTAR PRADESH
226003
India 
Phone  9721250092  
Fax    
Email  gaganmlv@gmail.com  
 
Source of Monetary or Material Support  
Department of Obstetrics and Gynaecology Queen Mary Hospital King Georges Medical University Shahmina Road chowk Lucknow Uttar Pradesh PIN code 226001  
 
Primary Sponsor  
Name  Room No Unit II king george medical college queen Mary hospital  
Address  Department of Obstetrics and Gynaecology Queen Mary Hospital King Georges Medical University Shahmina Road chowk Lucknow 226001  
Type of Sponsor  Government 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 
Dr Manju Lata Verma  King George medical university Lucknow Uttar Pradesh 226001  Department of Obstetrics and Gynaecology Queen Mary Hospital Room no 2 unit II Shahmina Road Lucknow
Lucknow
UTTAR PRADESH 
9721250092

gaganmlv@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O668||Other specified obstructed labor,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Its RANDOMISED CONTROL TRIAL MISOPROSTOL tablet in form of solution (200microgram tablet in 200 ml water is dissolved and every 2 hourly 20ml of solution used for labor induction instead of 25microgram tablet per vaginally) Total 10doses will given (20ml*10=200 ml=200micrograms)  This study compares the efficacy of oral misoprostol solution versus vaginal misoprostol tablets for labor induction. It evaluates maternal and fetal outcomes, induction-to-delivery interval, and adverse effects. A randomized controlled trial will be conducted on pregnant women requiring labor induction to determine the optimal route for safety, effectiveness, and better obstetric outcomes. 
Comparator Agent  The comparator in this study is vaginal misoprostol tablets, which are commonly used for labor induction. Their efficacy will be compared with oral misoprostol solution in terms of induction-to-delivery time, mode of delivery, maternal and fetal outcomes, and adverse effects. This comparison aims to determine the safer and more effective route for labor induction.  The comparator in this study is vaginal misoprostol tablets, which are commonly used for labor induction. Their efficacy will be compared with oral misoprostol solution in terms of induction-to-delivery time, mode of delivery, maternal and fetal outcomes, and adverse effects. This comparison aims to determine the safer and more effective route for labor induction. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Singleton live pregnancy,
34 weeks gestation,
Bishop score more than 6,
Intact membranes,
Cephalic presentation,
Reassuring fetal heart rate
Patients giving written informed consent will be taken
 
 
ExclusionCriteria 
Details  Hypersensitivity to misoprostol,
Previous cesarean delivery or other uterine surgery,
Uterine contractions, and
Significant maternal cardiac, renal, or liver disease.
Not giving consent
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Induction delivery interval and rate of lower segment cesarean section (LSCS)
 
• Outcome will be assessed between 24-48 hours  
 
Secondary Outcome  
Outcome  TimePoints 
• To assess the effectiveness, safety profile, & impact on maternal & neonatal outcomes.  • from induction to delivery of baby up to 48hours
Mode of delivery
Any uterine hyper stimulation
Feral heart rate abnormalities
Medium stained liquor
Nice admission morbidity/mortality
 
 
Target Sample Size   Total Sample Size="188"
Sample Size from India="188" 
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   N/A 
Date of First Enrollment (India)   22/03/2025 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The study will be conducted at the Department of Obstetrics and Gynaecology, King George’s Medical University, Lucknow, involving all antenatal women admitted. The study design is a prospective comparative study, with a sample size of 94 each group. The inclusion criteria include singleton live pregnancy, 34 weeks gestation, Bishop score 6, intact membranes, cephalic presentation, and reassurance fetal heart rate. Patients who give written informed consent will be included. Exclusion criteria include hypersensitivity to misoprostol, previous cesarean delivery or other uterine surgery, uterine contractions, and significant maternal cardiac, renal, or liver disease. All women fulfilling the included and exclusion criteria will be enrolled in the study. They will be randomly divided into treatment groups (hourly titrated-dose or static dose every 2 hours) using computer-generated numbers. Labor management will follow standard protocol, including electronic fetal monitoring. Intramuscular or intravenous analgesia will be given for pain relief during labor, and delivery will be carried out under the supervision of a consultant. Oral misoprostol solution will be administered as a 1-mg/mL solution prepared from a 200-mg misoprostol tablet dissolved in 200 mL water. The hourly titrated-dose group will receive 20-mg oral misoprostol administered hourly for 4 doses, while the static-dose group will receive 25 mg oral misoprostol administered every 2 hours for a maximum of 12 doses or until the onset of regular uterine activity. No further misoprostol will be given once regular uterine activity was observed. If contractions became inadequate, oxytocin will be provided 2 hours after the last misoprostol dose. The primary outcome is successful labor induction, defined as vaginal delivery within 24 hours after treatment initiation. Secondary outcomes include rate of cesarean delivery and need for oxytocin augmentation. Safety outcomes include incidence of maternal morbidity and adverse neonatal outcomes. Data analysis will be performed using IBM SPSS 26.0 or above software. Dichotomous variables will be compared between groups using Fisher’s exact test, while continuous variables will be compared using Chi-square test, paired t-test, and Independent Samples t-test. Confidence level of the study will be kept at 95%.

 
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