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CTRI Number  CTRI/2025/01/079669 [Registered on: 28/01/2025] Trial Registered Prospectively
Last Modified On: 12/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   STUDY ON THE USE OF MIFEPRISTONE AND MISOPROSTOL" 
Scientific Title of Study   ACCEPTABILITY OF MIFEPRISTONE AND MISOPROSTOL DURING FIRST TRIMESTER PREGNANCY MEDICAL TERMINATION OF PREGNANCY AT A TERTIARY CARE HOSPITAL. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  NARMATHA R 
Designation  M.PHARMACY- PHARMACY PRACTICE  
Affiliation  SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH 
Address  DEPARTMENT OF PHARMACY PRACTICE, FACULTY OF PHARMACY, SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH,PORUR, CHENNAI.

Chennai
TAMIL NADU
600116
India 
Phone  6385592590  
Fax    
Email  p1123001@sriher.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr A MOHATHASIM BILLAH 
Designation  PROFESSOR 
Affiliation  SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH 
Address  DEPARTMENT OF PHARMACY PRACTICE, FACULTY OF PHARMACY, SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH,PORUR, CHENNAI.

Chennai
TAMIL NADU
600116
India 
Phone  9488588735  
Fax    
Email  amb@sriramachandra.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr G Dhanalakshmi 
Designation  PROFESSOR 
Affiliation  SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH 
Address  DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY, SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH,PORUR, CHENNAI.

Chennai
TAMIL NADU
600116
India 
Phone  9841432362  
Fax    
Email  dhanalakshmi@sriramachandra.edu.in  
 
Source of Monetary or Material Support  
Sri Ramachandra Institute of Higher Education and Research, Deemed to be University, Porur, Chennai-600116 
 
Primary Sponsor  
Name  Sri Ramachandra Institute of Higher Education and Research 
Address  Sri Ramachandra Institute of Higher Education and Research, Deemed to be University, Porur, Chennai-600116 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
NARMATHA R  Sri Ramachandra Hospital  Sri Ramachandra Hospital 3rd Floor Post Operative Ward Obstetrics and Gynaecology Department
Chennai
TAMIL NADU 
6385592590

p1123001@sriher.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee For student Projects  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  3.00 Month(s)
Gender  Female 
Details  1.Women who seeking Medical Termination of Pregnancy at First-trimester gestation.
2.Women seeking medical termination of pregnancy and providing informed consent.
3.Patient undergo MTP as family planning and medical needs. 
 
ExclusionCriteria 
Details  1. Ectopic Pregnancy
2. Intrauterine pregnancy more than 63 days of gestation
3. Unmarried pregnancy
4. Any previous attempts at terminating the present pregnancy, coagulation disorders, uncontrolled hypertension and anaemia with Hb greater than 8 gm percentage. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Determine the acceptability of mifepristone and misoprostol among patients during First trimester pregnancy termination.  7–14 days  
 
Secondary Outcome  
Outcome  TimePoints 
1. Ensure the safety & efficacy profile of Mifepristone & Misoprostol in Medical Termination of Pregnancy.
2. Assess the effectiveness of these drugs in various gravidity.
3. Investigate any potential risks or adverse effects associated with their use in first trimester pregnancy termination. 
7-14 Days 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/02/2025 
Date of Study Completion (India) 02/06/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

RESULTS:

We conducted a study on " Acceptability of Mifepristone and Misoprostol during First Trimester Pregnancy Medical Termination of Pregnancy at a Tertiary care hospital" with CTRI Registration Number CTRI/2025/01/079669

Study Design

Observational Prospective Cohort Study

Study Duration

6 months

Study Start Date 

10 Feb 25 (First patient screened)

Study End Date

02 Jun 25 (Last subject last visit)

Total no. of. Study sites

1

Total no. of. Subjects planned initially

35

Actual no. of. Subjects recruited in the study

35

 

The data were collected from 35 women participants in their first trimester of pregnancy. The study protocol was thoroughly explained to each participant in their local language, and informed consent was obtained prior to enrollment. The collected data includes demographic details, safety profile, efficacy profile, side effects, recovery status, and the acceptability of Medical Termination of Pregnancy (MTP) using Mifepristone and Misoprostol. After the data collection, statistical analysis was performed.

In the demographic details regarding age distribution, among the 35 participants, the majority 27 participants (77%) were aged between 20 and 30 years, making this the most common age group seeking medical termination of pregnancy (MTP). 7 participants (20%) were older than 31 years, while only one participant (3%) was younger than 20 years. The mean age was 2.20 with a standard deviation of 0.531. In terms of gravidity, 14 participants (40%) had experienced two pregnancies, 13 (37%) had three pregnancies, 5 (14%) had four pregnancies, and 3 (9%) were primigravida, with a mean gravidity of 2.57 ± 0.85. Regarding parity distribution, 16 participants (45.71%) had two previous childbirths, 15 (42.86%) had one prior childbirth, 3 (8.57%) were nulliparous, and only 1 participant (2.86%) had three previous childbirths, with mean parity of 1.43 ± 0.70.

In the safety profile, the distribution of gestational age at the time of medical termination of pregnancy (MTP) was fairly even across weeks 5 to 7. Among the 35 participants, 12 (34.29%) underwent MTP at 5 weeks, another 12 (34.29%) at 7 weeks, and 11 (31.42%) at 6 weeks. The mean gestational age was 6.00 weeks with a standard deviation of 0.84. Regarding medical history, nearly all participants (34; 97.14%) had no comorbidities, indicating their suitability for MTP, while only one participant (2.86%) had diabetes mellitus. Obstetric history showed that most participants had previous live births, with 24 reporting past deliveries. Overall, 32 participants had experienced childbirth, and 9 had undergone Caesarean sections. Currently, only 2 participants were lactating. Concerning the route of administration, all 35 participants (100%) received mifepristone orally. Misoprostol was administered orally to 13 (37.14%) participants, vaginally to 2 (5.72%), and through a combined oral and vaginal route in 20 (57.14%) participants, with the combined method being the most common.

In the efficacy profile, the success rate of medical termination of pregnancy (MTP) was high, with complete abortion achieved in 25 participants (71%), while 10 participants (29%) experienced incomplete abortion and required additional medical intervention. The mean abortion outcome was 1.29 with a standard deviation of 0.458. Statistical analysis using the chi-square test revealed a significant association between gestational age and abortion outcome (p = 0.017), indicating that the success rate decreases as gestational age increases. Additionally, comparison of the route of misoprostol administration with abortion outcomes showed that the highest success rate was observed with the combined oral and vaginal route, while vaginal-only administration resulted in incomplete abortion in all cases (p = 0.070).

Common side effects among 35 MTP participants, bleeding was the most frequently by 33 individuals. Vomiting affected 25 participants, while cramping was noted in 16. Nausea occurred in 9 cases, and fever was reported by only 1 participant. These symptoms align with common side effects observed after MTP, reflecting typical responses to the medications used.

Regarding menstrual recovery status, 24 participants (68.57%) experienced regular menstrual cycles after MTP, indicating smooth recovery. However, 11 participants (31.43%) had irregular cycles, insisting the need for follow-up beyond two weeks in about one-third of cases to provide reassurance or intervene if irregularities continue. In terms of Follow-up recovery, 29 participants (82.86%) fully recovered following MTP, while 6 (17.14%) had not yet fully recovered, reflecting a high clinical success rate.

Regarding the acceptability of MTP, 16 participants (45.71%) found the experience with medical abortion process not at all or slightly difficult, while 17 (48.57%) described it as moderately difficult. Only 2 (5.71%) reported it as very difficult, indicating that most found the procedure manageable. For acceptability of side effects, 21 participants (60%) considered them very acceptable or acceptable, 13 (37.14%) rated them as neutral, and only 1 (2.86%) found them very unacceptable or unacceptable, showing good overall tolerance. In terms of acceptability of misoprostol administration, 16 participants (45.71%) rated it as very acceptable or acceptable, 18 (51.43%) as neutral, and 1 (2.86%) as very unacceptable or unacceptable, reflecting general acceptability. For future abortion methods, medical abortion was preferred by 20 participants (57.14%), 14 (40%) had no specific preference, and only 1 (2.86%) chose vacuum aspiration.

 
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