| CTRI Number |
CTRI/2024/11/077177 [Registered on: 21/11/2024] Trial Registered Prospectively |
| Last Modified On: |
20/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two different doses of vaginal misoprostol for second trimester pregnancy termination in women with previous caesarean section |
|
Scientific Title of Study
|
Efficacy and safety of two different doses of vaginal misoprostol for second trimester pregnancy termination in women with previous caesarean section- A Randomised Controlled Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Puneet Kaur |
| Designation |
Post graduate student |
| Affiliation |
post graduate student |
| Address |
Department of obstetric and gynecology, Maulana azad medical college
New Delhi
DELHI
110002
India |
| Phone |
9815533517 |
| Fax |
|
| Email |
doc.puneet517@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishna Agarwal |
| Designation |
Professor |
| Affiliation |
Lok Nayak Hospital |
| Address |
Department of Obstetrics and Gynecology
Lok Nayak Hospital
New Delhi
DELHI
110002
India |
| Phone |
9968604350 |
| Fax |
|
| Email |
drkrishna.agarwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishna Agarwal |
| Designation |
Professor |
| Affiliation |
Lok Nayak Hospital |
| Address |
Department of Obstetrics and Gynecology
Lok Nayak Hospital
DELHI
110002
India |
| Phone |
9968604350 |
| Fax |
|
| Email |
drkrishna.agarwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lok Nayak Hospital, New Delhi
110002
India |
|
|
Primary Sponsor
|
| Name |
LOK NAYAK HOSPITAL |
| Address |
BAHADURSHAH ZAFAR MARG, 110002,
New Delhi
India |
| 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 Puneet Kaur |
LOK NAYAK HOSPITAL |
Septic labour room, near gynae casualty ground floor, Deptt of obs and gynae, Lok nayak hospital, Bahadur shah zafar marg
New Delhi
DELHI |
9815533517
doc.puneet517@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and associated hospital, GB pant institute of postgraduatemedical education GIPMER and research hospital guru nanak eye centre new delhi 110002 INstituitional Ethics committee |
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 |
MISOPROSTOL |
200mcg dose vaginally every 3 hrs for max of 5 doses
if no result repeat of the 5 doses at 3 hr interval |
| Comparator Agent |
MISOPROSTOL |
400mcg dose vaginally every 3hrly for a maximum of 5 doses |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1.Singleton pregnancy
2.Previous one or two caesarean section
3.Period of gestation:12 week 0 days to 24 weeks 0 days
|
|
| ExclusionCriteria |
| Details |
1.Women with known heart disease
2.Women with low lying placenta
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Rate of Sucess of abortion in two groups.
Induction abortion interval in hours in both the regimens.
Completeness of Abortion (need for surgical evacuation)- Percentage of cases requiring surgical evacuation or curettage due to retained products of conception in the two groups. |
start and completion of abortion process |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Incidence of side effects related to misoprostol (nausea, vomiting).
2.Amount of blood loss (in ml): Amount of blood loss will be compared in both arms by using the pictorial method.
3.Number of women having scar dehiscence and scar complication
4.Post-abortive infection (Time frame- 7 days): rate of post-abortive infection in two groups.
|
start and completion of abortion process till 7 days post abortion |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/12/2024 |
| 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
|
Second trimester termination of pregnancy approximately accounts for 10-15% of abortions being performed worldwide and its incidence is gradually increasing. The challenges faced by an obstetrician increase as the number of previous caesarean increase as there is no consensus on safe method of termination in these cases. We planned this study to find out the efficacious and safe dose of misoprostol for second trimester termination of pregnancy in women with previous caesarean section as there’s higher chance of complications in scarred uterus compared to unscarred uterus |