Unwanted pregnancy in women with a previous cesarean section scar. The study focuses on medical termination of pregnancy using misoprostol and evaluates safety concerns such as risk of uterine rupture, excessive bleeding, incomplete abortion, and the need for surgical intervention. Pregnancy termination, Misoprostol, Cesarean section, Uterine rupture, Medical abortion, Post-cesarean pregnancy, Maternal safety, Uterine scar, Obstetrics, Gynecology
Conditions
Interventions
Participants will receive misoprostol 400 micrograms administered vaginally or sublingually every 4 hours, up to a maximum cumulative dose of 1600 micrograms, as per institutional protocol. This regim
Experimental Drug,Active Comparator Drug
Full Dose Misoprostol,Half Dose Misoprostol
Sponsors
College of Physicians and Surgeons Pakistan (CPSP), through its Research & Training Monitoring Cell (RTMC), in collaboration with the Department of Obstetrics and Gynaecology, Jinnah Postgraduate Medical Centre (JPMC), Karachi. CPSP takes responsibility for academic oversight and registration requirements, while JPMC provides institutional support, facilities, and supervision for the conduct of the study.
Eligibility
Sex/Gender
Female
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1. Women aged 20 to 40 years 2. Confirmed intrauterine pregnancy of 12 weeks gestation or less (by ultrasound) 3. History of one previous lower segment cesarean section 4. Medically indicated termination of pregnancy 5. Willingness to provide informed consent
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1. More than one previous cesarean section 2. History of uterine rupture 3. Known uterine anomalies such as bicornuate uterus 4. Multiple pregnancy 5. Placenta previa 6. Known hypersensitivity or allergy to misoprostol or other prostaglandins 7. Active cardiovascular disease including unstable angina or recent myocardial infarction 8. Severe asthma not well controlled 9. Glaucoma 10. Adrenal insufficiency 11. Severe hepatic impairment 12. Severe renal impairment 13. Suspected or confirmed ectopic pregnancy 14. Unexplained vaginal bleeding unrelated to pregnancy 15. Previous classical vertical cesarean incision or uterine surgery involving the fundus 16. Any known condition that increases the risk of uterine rupture 17. Hemodynamically unstable patients with systolic blood pressure less than 90 mmHg or heart rate greater than 120 beats per minute at baseline or prior to intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful complete abortion within 24 hours 24 hours after first dose of misoprostol Clinical pelvic examination and/or transvaginal ultrasound scan confirming absence of products of conception,Time to complete abortion Within 24 hours after first dose Hours recorded from first misoprostol dose to clinically documented completion in medical notes,Excessive vaginal bleeding During admission or within 24 hours after first dose Clinical diagnosis requiring blood transfusion or hemodynamic support,Suspected uterine rupture During admission Clinical diagnosis confirmed intraoperatively or by imaging,Hemoglobin drop At baseline and at 24 hours or before discharge Difference between baseline and post-procedure hemoglobin (g/dL),Fever Within 24 hours after first dose Temperature greater than or equal 38.0 C on vital signs chart,Pain severity Peak score recorded within 24 hours after first dose Patient reported numeric rating scale (1 -10),Gastrointestinal side effects Within 24 hours after first dose Presence of nausea, vomiting, or diarrhea recorded by nursing staff | — |
Secondary
| Measure | Time frame |
|---|---|
| Analgesic requirement Within 24 hours after first dose Any use of rescue analgesics documented in medication chart,Patient satisfaction At discharge Five point Likert scale (1-5) completed at discharge,Length of hospital stay At discharge Hours from admission to discharge noted in patient file | — |
Countries
Pakistan
Contacts
Public ContactDr Albakhtawar Albakhtawar
Department of Obstetrics and Gynaecology, Jinnah Postgraduate Medical Centre (JPMC), Karachi
Outcome results
None listed