Letrozole Pretreatment With Misoprostol for Induction of Abortion In First-Trimester Missed Miscarriage Among Women With One or More Previous Cesarean Deliveries.: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Cairo University
- Enrollment
- 200
- Primary Endpoint
- induction to abortion time
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Gestational age less than 64 days gestation (<9 wks).
- •Hemoglobin >10 g/dL.
- •BMI between 18.5 kg/m2 and 25 kg/m
- •Missed abortion.
- •previous one or more cesarean delivaries
Exclusion Criteria
- •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.
Arms & Interventions
study group
3 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.
Intervention: letrozole then misoprostol (Drug)
control group
three 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
Intervention: placebo then misoprostol (Drug)
Outcomes
Primary Outcomes
induction to abortion time
Time Frame: 6 hours
induction to abortion time
Incidence of complete miscarriage
Time Frame: 6 hours
Incidence of complete miscarriage
Secondary Outcomes
- Need for surgical evacuation of the products of conception(6 hours)
Investigators
Ahmed Samy aly ashour
assistant professor obstetrics and gynecology
Cairo University