Use of Aromatase Inhibitor Before Misoprostol in Medical Termination of Miscarriage
Comparison Between the Use of Aromatase Inhibitor Before Misoprostol and Use of Misoprostol Alone in Medical Termination of Miscarriage
1 other identifier
interventional
70
1 country
1
Brief Summary
Abortion is one of the most common complications of pregnancy. Missed abortion is a type of abortions, occurs in 15%-20% of clinically diagnosed pregnancies and is defined as the retention of pregnancy products in the uterus for several days or weeks after death of the fetus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 10, 2025
CompletedFirst Submitted
Initial submission to the registry
July 31, 2025
CompletedFirst Posted
Study publicly available on registry
August 7, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2025
CompletedAugust 7, 2025
July 1, 2025
5 months
July 31, 2025
July 31, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Miscarriage Achievement
The induction-to-abortion interval in each group
10 days
Study Arms (2)
Group A: letrozole and Misoprostol
ACTIVE COMPARATORAbout 35 pregnant women will receive aromatase inhibitor (letrozole) 2.5 mg tablet three times daily for 3 days followed by two doses of 400 micrograms of misoprostol administered vaginally on the 4th day of enrolment (two 200-μg tablets spaced 4 hours apart).
Group B: Misoprostol
ACTIVE COMPARATORAbout 35 pregnant women will receive two doses of 400 µg of vaginal misoprostol (two 200-μg tablets spaced 4 hours apart).
Interventions
to determine the effect of Letrozole as a premedication before misoprostol treatment used to induce missed miscarriage.
Eligibility Criteria
You may qualify if:
- Missed or anembryonic pregnancy.
- Gestational age from 4 weeks to 26 weeks of pregnancy (confirmed by ultrasound scanning on first day of admittance).
- Hemoglobin level more than 9g/l.
- Closed cervix.
- No product of conception in the cervical canal.
You may not qualify if:
- Previous attempt to terminate the pregnancy.
- Molar pregnancy
- Abnormal uterine lesions such as fibroids or congenital mal formations.
- Pregnancy despite of intrauterine contraceptive device.
- Medical disorders as cardiac, renal or hemorrhagic diseases.
- BMI more than 35 kg/m2.
- Known hypersensitivity to any of the medication used.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aswan Universitylead
Study Sites (1)
Aswan University Hospital
Aswān, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hani Ahmed Farouk, Assist.Prof.
Obstetrics and Gynecology,Faculty of Medicine,Aswan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Demonstrator at Obstetrics and Gynecology, Faculty of medicine
Study Record Dates
First Submitted
July 31, 2025
First Posted
August 7, 2025
Study Start
July 10, 2025
Primary Completion
December 1, 2025
Study Completion
December 10, 2025
Last Updated
August 7, 2025
Record last verified: 2025-07