| CTRI Number |
CTRI/2026/01/102107 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
How psychological support helps improve mental recovery after medical termination of pregnancy and missed abortion. |
|
Scientific Title of Study
|
Effect of psychological support on mental recovery after Medical Termination of Pregnancy and Missed 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 Pallavi Gupta |
| Designation |
Assistant Professor (OBGYN) |
| Affiliation |
Maulana Azad Medical College |
| Address |
Gynae ward 1st floor Lok Nayak Hospital , Bahadur Shah Zafar Marg, New Delhi, Delhi 110002
Central
DELHI
110002
India |
| Phone |
8860980726 |
| Fax |
|
| Email |
Pallavigupta136@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pallavi Gupta |
| Designation |
Assistant Professor (OBGYN) |
| Affiliation |
Maulana Azad Medical college |
| Address |
Gynae ward 1st floor, Lok Nayak hospital Bahadur Shah Zafar Marg, New Delhi, Delhi 110002
Central
DELHI
110002
India |
| Phone |
8860980726 |
| Fax |
|
| Email |
Pallavigupta136@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pallavi Gupta |
| Designation |
Assistant Professor (OBGYN) |
| Affiliation |
Maulana Azad Medical college |
| Address |
Gynae ward 1st floor, Lok Nayak hospital Bahadur Shah Zafar Marg, New Delhi, Delhi 110002
Central
DELHI
110002
India |
| Phone |
8860980726 |
| Fax |
|
| Email |
Pallavigupta136@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi, India 110002 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Pallavi Gupta |
Lok Nayak Hospital |
1st floor gynae ward 1A Department of obstetrics and gynaecology LNH Jawaharlal Nehru Marg, Maulana Azad Medical College Campus, New Delhi, Delhi, 110002
Central
DELHI |
8860980726
Pallavigupta136@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College |
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 |
Standard Care |
Routine post procedure care only |
| Intervention |
Structured psychological counselling |
Routine post-procedure care along with a single 30-minute structured medical counselling session including emotional support, reassurance, psycho-education, addressing guilt, validation, and answering patient queries. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Women aged 18 to 45 years who are undergoing Medical Termination of Pregnancy (MTP)/ missed abortion.
2. Women able to understand and respond to psychological assessment tools (e.g., in Hindi or English). |
|
| ExclusionCriteria |
| Details |
Women with incomplete abortion/ complete abortion. |
|
|
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 |
1. To assess the overall health and wellbeing of women undergoing Medical Termination of Pregnancy or Missed abortion.
2. To assess and compare the outcomes of medical counselling in the intervention group versus the control group. |
1. Baseline
2. Post procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="158"
Sample Size from India="158"
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)
|
05/02/2026 |
| 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="0"
Months="4"
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
|
1)The study will improve understanding of the psychological impact and perceived loss among women undergoing MTP/abortion.
2)Use of standardized questionnaires will help objectively assess grief and identify women who may benefit from psychological counselling.
3)If counselling shows improvement in psychosocial outcomes, it may be incorporated as a routine part of comprehensive abortion care. |