| CTRI Number |
CTRI/2026/02/102731 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Addition of a new drug to the standard regimen of drugs to escalate abortion process in second trimester abortion in pregnancy |
|
Scientific Title of Study
|
Efficacy of addition of vaginal Dinoprostone gel(PGE2) to the mifepristone-misoprostol regimen for the second trimester termination of pregnancy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anjali Kumari |
| Designation |
Post graduate student |
| Affiliation |
Aiims Jodhpur |
| Address |
AIIMS JODHPUR ,2nd phase , M.I.A 1st phase ,Basni, Jodhpur , Rajasthan, Department of Obstetrics and Gynaecology , 2nd floor
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9546201651 |
| Fax |
|
| Email |
anjali234k@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka Kathuria |
| Designation |
Associate Professor |
| Affiliation |
Aiims Jodhpur |
| Address |
AIIMS JODHPUR ,2nd phase , M.I.A 1st phase ,Basni, Jodhpur , Rajasthan,Department of Obstetrics and Gynaecology , 2nd floor
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7014982778 |
| Fax |
|
| Email |
dr.priyankathuria@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Kathuria |
| Designation |
Associate Professor |
| Affiliation |
Aiims Jodhpur |
| Address |
AIIMS JODHPUR ,2nd phase , M.I.A 1st phase ,Basni, Jodhpur , Rajasthan , department of obstetrics and gynaecology ,2nd floor
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7014982778 |
| Fax |
|
| Email |
dr.priyankathuria@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Anjali Kumari |
| Address |
AIIMS JODHPUR , 2nd phase , M.I.A , BASNI , JODHPUR , RAJASTHAN 342005 |
| 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 Anjali Kumari |
AIIMS JODHPUR |
Department of Obstetrics and Gynaecology , 2nd floor,2nd phase , M.I.A 1st phase ,Basni, Jodhpur , Rajasthan
Jodhpur
RAJASTHAN |
09546201651
anjali234k@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Comittee(Clinical Trial) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O048||(Induced) termination of pregnancywith other and unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dinoprostone gel |
reduction in induction to abortion time interval by addition of 1 dinoprostone gel(0.5mg) to the standard regimen of second trimester abortion(oral mifepristone 200 mg followed by 1 dinoprostone gel 0.5 mg vaginally after 30 hrs followed by first dose of Tab Misoprostol 400 mcg after 36 hrs of mifepristone and will be repeated every 3 hrs(max 5 doses) |
| Comparator Agent |
Standard Mifepristone-Misoprostol regimen |
Induction-abortion time interval by standard regimen of Mifepristne-Misoprostol regimen
(Tab Mifepristone 200 mg per orally followed by Misoprostol 400 mcg doses every 3 hrs ( max 5 doses) after 36 hrs |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Women with 12-24 weeks POG elih=gible for second trimester termination of pregnancy as per MTP act.
Women with fetal demise between 12-24 weeks
Signed informed consent to participate in the study |
|
| ExclusionCriteria |
| Details |
Women who refuse to give consent for this study.
Women with multiple pregnancies.
Women with previous Cesarean section.
Women with a certain degree of cervical dilatation.
Women with allergy or contraindication to either drug
Those who have some contraindication to either drug |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Induction-abortion time interval will be calculated(interval between the adminsitration of first misoprostol dose and the time fetus will be aborted |
time interval between 1st misoprostol dose and after every 3 hours of misoprostol application till a maximum of 5 doses |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. less failure rate
2. Decreased need for surgical evacuation in incomplete cases & comparatively lower side effects |
failure rate assessment after a maximum of 5 misoprostol applications |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
10/02/2026 |
| 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="2"
Months="0"
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
|
All patients who meet eligibility for inclusion in the study will be approached for enrollment during either OPD visit or in the labor oom. If a patient is willing to participate in the study , enrollment in the study will be noted in the case record form. Written informed consent will be obtained from all study participants.Sealed envelopes will be used to randomly allocate groups to paticipants. Group A will receive routine Mifepristone 200 mg per orally followed by per vaginal examination at 30 hours followed by Misoprostol 400 mcg at 36 hours interval every 3 hourly for a maximum of 5 doses. Intervention group will also receive initially 200 mg Mifepristone followed 30 hours by 0.5 mg Dinoprostone gel vaginally followed by 400 mcg misoprostol every 3 hourly (max 5 doses) after 6 hours of dinoprostone gel application. During each dose adminstration , women’s vital signs will be monitored every 2 hourly and process of abortion will be assessed by vaginal examination every 4 houry. After the completion of abortion, the products of conception will be checked for its completeness and induction-abortion interval will be calculated and noted. If theabortion will be still incomplete , it will be completed using surgical evacuation. After the completion of abortion , patients will be observed for 24 hours before discharge and failure of abortion will be considered when a woman failed to abort within 15 hours of 1st dose of misoprostol.For failed cases ,other methods of termination will be undertaken.On discharge ,they will be asked for follow up after a week or earlier in emergent cases. On follow up cases , pelvic examination will be performed and an inquiry will be made of any abnormal bleeding or delayed sode effects |