Letrozole Pretreatment With Misoprostol Induction of Abortion In First-Trimester Missed Miscarriage
1 other identifier
interventional
200
0 countries
N/A
Brief Summary
This study compares the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of first-trimester pregnancy among women with one or more previous cesarean deliveries.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2020
Shorter than P25 for phase_4
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
First Submitted
Initial submission to the registry
December 30, 2019
CompletedFirst Posted
Study publicly available on registry
January 2, 2020
CompletedStudy Start
First participant enrolled
January 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 5, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2020
CompletedJanuary 2, 2020
December 1, 2019
3 months
December 30, 2019
December 30, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
induction to abortion time
induction to abortion time
6 hours
Incidence of complete miscarriage
Incidence of complete miscarriage
6 hours
Secondary Outcomes (1)
Need for surgical evacuation of the products of conception
6 hours
Study Arms (2)
study group
EXPERIMENTAL3 tablets of Letrozole 2.5 mg will be given as single daily dose, 7.5 mg per day for two days at home and the third dose will be given on admission to hospital on day 3 and will be followed by vaginal misoprostol 800 mcg every three hours up to maximum two doses.
control group
PLACEBO COMPARATORthree tablets of placebo will be given as a single daily dose, for two days at home and will be admitted on day 3 and continue treatment with misoprostol 800 mcg every three hours up to maximum two doses
Interventions
Drug: Letrozole 2.5mg total dose 7.5 mg per day for 3 days Drug: Misoprostol Misoprosrol 800mcg will be given to all patients for induction of abortion
Drug: Placebo placebo for 3 days Drug: Misoprostol Misoprosrol 800mcg will be given to all patients for induction of abortion
Eligibility Criteria
You may qualify if:
- Gestational age less than 64 days gestation (\<9 wks).
- Hemoglobin \>10 g/dL.
- BMI between 18.5 kg/m2 and 25 kg/m2.
- Missed abortion.
- previous one or more cesarean delivaries
You may not qualify if:
- Molar pregnancy.
- Fibroid uterus.
- Uterine anomalies.
- Coagulopathy.
- Medical disorder that contraindicate induction of abortion (e.g. heart failure).
- Previous attempts for induction of abortion in the current pregnancy.
- Allergy to misoprostol or letrozole.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
AHMED SAMY
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant professor obstetrics and gynecology
Study Record Dates
First Submitted
December 30, 2019
First Posted
January 2, 2020
Study Start
January 5, 2020
Primary Completion
April 5, 2020
Study Completion
April 10, 2020
Last Updated
January 2, 2020
Record last verified: 2019-12