| CTRI Number |
CTRI/2025/07/089975 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
01/07/2025 |
| 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 evaluate the safety of efficacy of different drugs in second trimester abortion |
|
Scientific Title of Study
|
To evaluate the safety and efficacy of Mifepristone with Misoprostol versus Dinoprostone gel with Misoprostol in second trimester pregnancy termination in tertiary care centre |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Geetha Shree B |
| Designation |
Obstetrics and Gynaecology post graduate |
| Affiliation |
Belagavi institute of medical sciences |
| Address |
Labour room , mother and child unit Belagavi institute of medical sciences, Dr Ambedkar road , Belagavi
Belgaum
KARNATAKA
590019
India |
| Phone |
7975879942 |
| Fax |
|
| Email |
geethurohi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunita Kittali |
| Designation |
Assistant Professor Obstetrics and Gynaecology |
| Affiliation |
Belagavi institute of medical sciences |
| Address |
Labour room , mother and child unit , Belagavi institute of medical sciences, Dr Ambedkar road , Belagavi
Belgaum
KARNATAKA
590019
India |
| Phone |
9480208858 |
| Fax |
|
| Email |
sunitamsog@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunita Kittali |
| Designation |
Assistant Professor Obstetrics and Gynaecology |
| Affiliation |
Belagavi institute of medical sciences |
| Address |
Labour room , Mother and Child unit , Belagavi institute of medical sciences, Dr Ambedkar road , Belagavi
Belgaum
KARNATAKA
590019
India |
| Phone |
9480208858 |
| Fax |
|
| Email |
sunitamsog@gmail.com |
|
|
Source of Monetary or Material Support
|
| Belagavi institute of medical sciences |
|
|
Primary Sponsor
|
| Name |
Dr Geetha Shree B |
| Address |
Belagavi institute of medical sciences Belagavi, Dr Ambedkar road , Belagavi |
| Type of Sponsor |
Other [Self] |
|
|
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 Geetha Shree B |
Belagavi institute of medical sciences |
Obstetrics and Gynaecology department, labour room
Belgaum
KARNATAKA |
7975879942
geethurohi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Belagavi Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O04||Complications following (induced)termination of pregnancy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Medical termination of pregnancy in second trimester by Mifepristone and Misoprostol |
tab Mifepristone 200mg oral after 48hrs tab Misoprostol 400mcg per vagina every 3 hours to maximum 5 doses |
| Comparator Agent |
Second trimester pregnancy termination using Dinprostone gel with Misoprostol tablet |
Dinoprostone gel inserted intracervical after 8 hours Tablet Misoprostol 400mcg per vagina every 3hours to maximum of 5 doses |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women between 18 to 45years seeking termination of pregnancy between 13-24 weeks of gestation fulfilling the prerequisites of Medical Termination of Pregnancy act 1971 and its amendments in 2021 |
|
| ExclusionCriteria |
| Details |
Women with hemoglobin less than 8mg/dl
Multiple Pregnancy
Women with coagulation disorder
Women with other medical disorders
Incomplete abortion
Patient with per vaginal leak
Low lying placenta
Patient with more than 1 previous cesarean section
Intrauterine death
Septic abortion
Molar pregnancy
Prior allergy to any of the drugs used in the study |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety and efficacy of Mifepristone and Misoprostol versus dinoprostone gel with Misoprostol in second trimester pregnancy termination; in terms of rate of complete abortion and induced abortion interval |
One year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare & analyse need for surgical evacuation, uterine rupture, blood loss , sepsis, pain & need for analgesia between the study group |
One year |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/07/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 focuses on evaluating second trimester pregnancy termination methods, specifically comparing the efficacy and safety of two medical regimens: Mifepristone followed by Misoprostol and Dinoprostone gel followed by Misoprostol. Abortion, defined as the termination of pregnancy before fetal viability, may be spontaneous or induced. In India, the Medical Termination of Pregnancy Act and its 2021 amendments allow abortion up to 24 weeks for specific categories and beyond that in cases of lethal fetal anomalies with medical board approval. While most abortions occur in the first trimester, 10 to 15 percentage of induced abortions globally and 12.9 percentage in India occur in the second trimester. The increase in second trimester abortions is largely attributed to improved antenatal screening techniques like ultrasound and serum tests that help detect fetal anomalies. Both surgical and medical methods are available for termination, but medical methods are preferred due to a lower risk of complications. Among medical options, prostaglandins like Misoprostol and Dinoprostone are used to induce abortion by ripening the cervix and causing uterine contractions. Misoprostol, a synthetic prostaglandin E1 analogue, is widely used due to its high efficacy, low cost, safety, and ease of storage at room temperature. Dinoprostone in gel form, is also used for labor induction and abortion. The present study evaluates the 2023 FIGO recommended protocol involving Mifepristone and Misoprostol, comparing it against Dinoprostone gel combined with Misoprostol. The primary objective is to compare the rate of complete abortion and the induction-to-abortion interval between the two drug regimens. The secondary objectives include assessing the need for surgical evacuation, uterine rupture, blood loss, sepsis, pain, and the requirement for analgesia. This randomized controlled trial will be conducted at the Department of Obstetrics and Gynecology, Belagavi Institute of Medical Sciences , Belagavi. The study population will consist of pregnant women between 13 and 24 weeks of gestation who meet the inclusion criteria and seek termination at BIMS. The study will run from March 2024 to September 2025. Participants will be randomly assigned into two groups using sequentially numbered opaque envelopes. Group 1 will receive Mifepristone followed by Misoprostol, while Group 2 will receive Dinoprostone gel followed by Misoprostol. The study aims to determine the most effective and safest combination for second-trimester pregnancy termination by analyzing outcomes across both groups. |