ACCEPTABILITY OF MIFEPRISTONE AND MISOPROSTOL DURING FIRST TRIMESTER PREGNANCY MEDICAL TERMINATION OF PREGNANCY AT A TERTIARY CARE HOSPITAL.

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.