| 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
|
|
|
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
|
|
|
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%. |