Letrozole Pretreatment With Misoprostol Versus Misoprostol Alone in Missed Abortion
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.
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 3, 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 3, 2020
January 1, 2020
3 months
December 30, 2019
January 1, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
complete abortion rate
Incidence of complete miscarriage
9 hours
time from induction to abortion
induction to abortion time interval
9 hours
Secondary Outcomes (1)
Need for surgical evacuation of the products of conception
9 hours
Study Arms (2)
study group
EXPERIMENTAL2 tablets of Letrozole 2.5 mg will be given as single daily doses, 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 three doses.
control group
PLACEBO COMPARATOR2 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 three doses
Interventions
total dose 5 mg per day for 3 days then Misoprosrol 800mcg will be given to all patients for induction of abortion
placebo tablets for 3 days then 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.
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.
- Scared uterus (previous myomectomy, cesarean section, hysterectomy and ruptured uterus).
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 3, 2020
Study Start
January 5, 2020
Primary Completion
April 5, 2020
Study Completion
April 10, 2020
Last Updated
January 3, 2020
Record last verified: 2020-01