| CTRI Number |
CTRI/2025/09/095303 [Registered on: 23/09/2025] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between expectant vs medical management with OCPs or Misoprostol for clearance of RPOCs of size less than 2.5cm below 20 weeks of period of gestation |
|
Scientific Title of Study
|
Comparative Efficacy of Expectant Management, Oral Contraceptive Pills and Misoprostol for Management of Retained Products of Conception following Miscarriage: A Randomized Controlled Trial |
| 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 JAPLEEN KAUR |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Department of Obstetrics and Gynaecology |
| Address |
Department of Obstetrics and Gynaecology,DR. B.R. AMBEDKAR STATE INSTITUTE OF MEDICAL SCIENCES, MOHALI
Rupnagar
PUNJAB
160055
India |
| Phone |
9501898059 |
| Fax |
|
| Email |
japleen18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NIDHI GUPTA |
| Designation |
DNB RESIDENT |
| Affiliation |
Department of obstetrics and gynaecology, DR. B.R. AMBEDKAR STATE INSTITUTE OF MEDICAL SCIENCES, MOHALI |
| Address |
Department of Obstetrics and Gynaecology, DR. B.R. AMBEDKAR STATE INSTITUTE OF MEDICAL SCIENCES, MOHALI
Department of Obstetrics and Gynaecology, DR. B.R. AMBEDKAR STATE INSTITUTE OF MEDICAL SCIENCES, MOHALI
Rupnagar
PUNJAB
160055
India |
| Phone |
8558881510 |
| Fax |
|
| Email |
nidhigupta233@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR NIDHI GUPTA |
| Designation |
DNB RESIDENT |
| Affiliation |
DR. B.R. AMBEDKAR STATE INSTITUTE OF MEDICAL SCIENCES, MOHALI |
| Address |
DR. B.R. AMBEDKAR STATE INSTITUTE OF MEDICAL SCIENCES, MOHALI,PUNJAB
Rupnagar
PUNJAB
160055
India |
| Phone |
8558881510 |
| Fax |
|
| Email |
nidhigupta233@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Obstetrics and gynaecology,
DR. B.R. AMBEDKAR STATE INSTITUTE OF MEDICAL SCIENCES, MOHALI |
|
|
Primary Sponsor
|
| Name |
DR BR AMBEDKAR STATE INSTITUTE OF MEDICAL SCIENCES MOHALI |
| Address |
DR. B.R. AMBEDKAR STATE INSTITUTE OF MEDICAL SCIENCES, MOHALI |
| 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 NIDHI GUPTA |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY |
DR. B.R. AMBEDKAR STATE INSTITUTE OF MEDICAL SCIENCES, MOHALI
Rupnagar
PUNJAB |
8558881510
nidhigupta233@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O034||Incomplete spontaneous abortion without complication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
comparison between expectant management and medical management with OCPs v/s medical management with Misoprostol tablets)of retained products of conception beloy 2.5 cm at 20 weeks or less period of gestation |
comparison between 3 arms
Intervention arms-
Group 1 - expectant management with antibiotics and hematinics,where small sized RPOCs ,less than 2.5 cm will get cleared off on there own along with next menses after 4 weeks
And
group 2nd- medical management with OCPs ,where patient after randomization are started on tablet Mala N (available in govt supply) for clearance of RPOCs after 4 weeks on completion of one cycle of OCPs.
compared with
3rd group - standard medical management with Misoprostol 800mcg tablets)of retained products of conception below 2.5 cm size at 20 weeks or less period of gestation by randomized control trial |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
PREGNANT WOMEN OF AGE 18 TO 45 YEARS
Spontaneous/Induced Miscarriage of Intrauterine pregnancy at Gestation Age LESS THAN 20 weeks
RPOCs Size 1 Cm To 2.5 Cm |
|
| ExclusionCriteria |
| Details |
Hemodynamically unstable patients requiring surgical interventions who are actively bleeding.
Patient with sepsis( Fever or raised TLC less than or equal to 15k OR Foul smelling discharge)
Patients with any coagulopathy disorders
Any contraindications of oral contraceptives
Any contraindications of Misoprostol
Any uncontrolled medical disorder in the patient
Any evidence of post molar RPOCs
Any scar RPOCs
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the successful clearance of RPOCs with use of expectant management or OCPs use compared with misoprostol managed following spontaneous or induced miscarriage.( failure being defined as the need for surgical management) |
within 4-6 weeks of enrolement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)1. To Compare the side effects of expectant management or OCPs use with misoprostol for clearance of retained products of conception
2)2. To Compare patient perception regarding use of expectant management or OCPs use with misoprostol for clearance of retained products of conception |
within 4-6 weeks of enrolement |
|
|
Target Sample Size
|
Total Sample Size="159"
Sample Size from India="159"
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)
|
01/10/2025 |
| 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
|
Recent evidence supports improved outcomes with expectant/alternative medically treated clearance of retained products of conception (RPOCs) in post-miscarriage pregnancy when compared with misoprostol management. There are few retrospectives, randomized controlled trials where the rates of the clearance of RPOCs were low or unchanged among expectantly managed or with oral contraceptive (OCP) use and managed with misoprostol group, whereas few trials showed an increase in the rate the clearance of RPOCs. Hence, there is a critical uncertainty about the effect of expectant management or OCP use on expulsion of RPOCs. In our study, 159 subjects with post-miscarriage retained products of conception of size 1-2.5 cm(measured in longest dimension) will be randomized into three groups: expectant management, medical management with oral contraceptive pills and medical management with misoprostol where expectantly managed and OCP used group will be compared with misoprostol group . Expectant management is the clearance of retained products of conception post miscarriage pregnancy in the absence of any pharmacologic or mechanical initiation. Medical management is any pharmacological intervention required for attaining the desired clearance of RPOCs here by using synthetic prostaglandin E1 (Misoprostol) Or by using oral hormone containing contraceptive pills constituting ethinylestradiol, levonorgestral and ferrous fumarate. |