Letrozole Plus Misoprostol Versus Misoprostol Alone for Treating Women With Missed Miscarriage
NCT ID: NCT07160855
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
92 participants
INTERVENTIONAL
2025-05-13
2025-11-12
Brief Summary
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The main questions this study aims to answer are:
1. Does taking letrozole for 3 days before misoprostol increase the chance of a complete abortion compared to misoprostol alone?
2. Does the use of letrozole affect the time it takes for abortion to occur? Who can Join? i. Women up to 13 weeks of pregnancy (based on last menstrual period and confirmed by ultrasound) who have a missed miscarriage.
ii. Only those with a single pregnancy are eligible. iii. Women with a previous cesarean section or uterine scar are not included.
What Will Happen in the Study A total of 92 women will take part.
Participants will be randomly assigned to one of two groups:
Group A: Letrozole tablets once daily for 3 days, followed by one dose of vaginal misoprostol.
Group B: Placebo tablets for maximum of 3 days, followed by one dose of vaginal misoprostol.
Doctors will monitor whether the abortion is complete within 24 hours. If it is not, other medical procedures will be offered as needed.
Products of conception will be examined to confirm abortion.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Misoprostol with placebo
Vaginal Misoprostol will be instituted after oral placebo
Misoprostol (given vaginally)
800 micrograms of a single dose of vaginal misoprostol will be given
Placebo
oral placebo for three days will be given
Misoprostol with Letrozole
After oral letrozole, vaginal Misoprostol will be instituted
Misoprostol (given vaginally)
800 micrograms of a single dose of vaginal misoprostol will be given
Letrozole 5 mg
10 mg oral letrozole for 3 days will be given
Interventions
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Misoprostol (given vaginally)
800 micrograms of a single dose of vaginal misoprostol will be given
Letrozole 5 mg
10 mg oral letrozole for 3 days will be given
Placebo
oral placebo for three days will be given
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Single intrauterine pregnancy
* Planned for termination due to missed miscarriage
Exclusion Criteria
* Uterine scar due to previous procedure like myomectomy
18 Years
45 Years
FEMALE
No
Sponsors
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Nishtar Medical University
OTHER
Responsible Party
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Afrayshum Tariq
Principal Investigator
Principal Investigators
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Rabia R Assistant Professor, FCPS
Role: STUDY_CHAIR
Nishtar Medical University and Hospital
Locations
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Nishtar Medical University and Hospital
Multan, Punjab Province, Pakistan
Countries
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Central Contacts
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Facility Contacts
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References
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Abbasalizadeh F, Sahhaf F, Sadeghi-Shabestari P, Mirza-Aghazadeh-Attari M, Naghavi-Behzad M. Comparison Between Effect of Letrozole Plus Misoprostol and Misoprostol Alone in Terminating Non-Viable First Trimester Pregnancies: A Single Blind Randomized Trial. J Family Reprod Health. 2018 Mar;12(1):27-33.
Other Identifiers
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U1111-1327-5077
Identifier Type: -
Identifier Source: org_study_id
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