Letrozole plus misoprostol compared with misoprostol alone for treating missed miscarriage
Comparison of Letrozole With Misoprostol Versus Misoprostol Alone in the Management of Missed Miscarriages
This trial will test whether taking letrozole for three days before misoprostol helps women up to 13 weeks with a missed miscarriage pass the pregnancy completely more often than misoprostol alone.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Nishtar Medical University Academic / other |
| Locations | 1 site (Multan, Punjab Province) |
| Trial ID | NCT07160855 on ClinicalTrials.gov |
What this trial studies
This randomized, controlled Phase 4 trial will enroll 92 women with a single missed miscarriage up to 13 weeks' gestation and assign them to receive either letrozole for three days followed by vaginal misoprostol or misoprostol with a placebo. The main outcomes are the rate of complete uterine evacuation and the time to expulsion after treatment. Women with a prior cesarean section or other uterine scar are excluded. Care and follow-up visits are conducted at Nishtar Medical University and Hospital in Multan.
Who should consider this trial
Good fit: Women up to 13 weeks' gestation with a single intrauterine missed miscarriage who are planning termination and have no prior cesarean or uterine scar would be ideal candidates.
Not a fit: People with prior cesarean section or other uterine scarring, multiple pregnancy, or pregnancies beyond 13 weeks are excluded and would not be expected to benefit from this protocol.
Why it matters
Potential benefit: If successful, the combination could raise the chance of a complete medical management of missed miscarriage and reduce the need for surgical procedures.
How similar studies have performed: Smaller trials and observational reports using letrozole or other pretreatments before misoprostol for early pregnancy termination have shown mixed but sometimes promising improvements in expulsion rates, so evidence is limited but suggestive.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant women up till 13th weeks of gestation according to last menstrual period (LMP) dates, confirmed on ultrasound * Single intrauterine pregnancy * Planned for termination due to missed miscarriage Exclusion Criteria: * Previous history of cesarean section * Uterine scar due to previous procedure like myomectomy
Where this trial is running
Multan, Punjab Province
- Nishtar Medical University and Hospital — Multan, Punjab Province, Pakistan (Recruiting)
Study contacts
- Study coordinator: Afrayshum T Principal Investigator, MBBS
- Email: afrayshumtariq@gmail.com
- Phone: +92 3336239197
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.