| CTRI Number |
CTRI/2024/06/069578 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
23/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial comparing the safety and efficacy of mifepristone and misoprostol either alone or when used with an intracervical Foleys catheter in women desiring second-trimester medical abortions |
|
Scientific Title of Study
|
Comparative study of mifepristone followed by misoprostol alone or combined with intracervical Foley’s catheter for second-trimester medical abortion |
| 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 Lakshyaa Chawla |
| Designation |
Junior resident |
| Affiliation |
Postgraduate institute of medical education & research, Chandigarh |
| Address |
Department of obstetrics and gynaecology,3rd floor, Nehru hospital, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh (160012)
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8209291910 |
| Fax |
|
| Email |
lakshyaachawla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Bagga |
| Designation |
Professor |
| Affiliation |
Postgraduate institute of medical education & research, Chandigarh |
| Address |
Department of obstetrics and gynaecology,3rd floor, Nehru hospital, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh (160012)
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872494602 |
| Fax |
|
| Email |
rashmibagga@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi Bagga |
| Designation |
Professor |
| Affiliation |
Postgraduate institute of medical education & research, Chandigarh |
| Address |
Department of obstetrics and gynaecology,3rd floor, Nehru hospital, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh (160012)
)
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872494602 |
| Fax |
|
| Email |
rashmibagga@gmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh (160012) |
|
|
Primary Sponsor
|
| Name |
Dr Lakshyaa Chawla |
| Address |
Department of obstetrics and gynaecology,3rd floor, Nehru hospital, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh (160012) |
| 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 Lakshyaa chawla |
Postgraduate Institute of Medical Education and Research , Chandigarh |
Department of Obst. and Gynae, 3rd floor,Nehru hospital ,Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh (160012)
Chandigarh
CHANDIGARH |
08209291910
lakshyaachawla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Intramural) Post Graduate Institute of Medical Education and Research , Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O08||Pregnancy with abortive outcome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Foley’s catheter(16 french) |
16 French Foley’s catheter inserted intracervical , instilled with 30ml saline (to kept intracervical for maximum of 12 hours). |
| Intervention |
Tablet Misoprostol |
Tablet Misoprostol 200 or 400 mcg,6 hourly ,per vaginally , for maximum 48 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Pregnant women seeking MTP between 16 to 24 weeks of gestation including women with previous one LSCS
2. Age ≥18 years
3. Single intrauterine viable pregnancy
4. Women fulfilling the pre-requisites of MTP amendment act, 2021 (India)
|
|
| ExclusionCriteria |
| Details |
1.Prior 2 or more uterine surgeries
2.Contraindications to mifepristone or misoprostol: ectopic pregnancy, inherited porphyria, chronic adrenal failure, on immunosuppressants (on corticosteroids), coagulation disorders
3.Chorioamnionitis or vaginal infections
4.Any medical or surgical disorders like heart disease , uncontrolled hypertension (≥160/100 mm Hg) or diabetes, bronchial asthma or any other medical illness
5.Haemoglobin ≤8 Gm/dl
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Comparison of the Induction- abortion interval (IAI) – Time period from initiation of induction
(misoprostol only i.e group A or foley’s + misoprostol i.e group B) to expulsion of fetus between above mentioned 2 groups.
|
11 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Comparison of completion of abortion within 24 hours between two groups.
2.To compare the need for curettage for retained placental tissue after abortion between two groups
3.To compare the side effects (like vomiting, diarrhoea and fever) between two groups.
4.Comparison of blood loss in both the groups.
5.To compare the Incidence of post abortal infection between two groups. |
11 months |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
Final Enrollment numbers achieved (Total)= "76"
Final Enrollment numbers achieved (India)="76" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
24/07/2024 |
| Date of Study Completion (India) |
23/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
23/04/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="11"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
we plan to administer two sequential doses of
mifepristone followed by misoprostol alone or combined with intracervical
foley’s catheter for second trimester medical abortion and see if we can
further reduce the IAI. A shortened IAI will be beneficial by reducing hospital
admission time and also have a favourable psychosocial impact on the women
undergoing MTP. |