Use of Letrozole Pretreatment With Misoprostol for Induction of Abortion in First Trimester Missed Abortion
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 110
- Primary Endpoint
- Complete abortion
Study Overview
Brief Summary
this study will compare the efficacy of using letrozole pre treatment before misoprostol versus using misoprostol only in the induction of first trimester missed abortion.
Detailed Description
Intervention type: drug
Intervention name: letrozole then misoprostol
Description :letrozole 2.5mg twice per day for 2days then misoprostol 800mcg for all patients to induce abortion
Arm group label:study group
Intervention type :drug
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
participant- care provider -investigator- outcomes assessor
Eligibility Criteria
- Ages
- 18 Years to 42 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Maternal age more than 18 years old.
- •Gestational age less than 13 weeks confirmed by ultrasound scan on day 1 of the study.
- •Hemoglobin >10 g/dl
- •Missed abortion
Exclusion Criteria
- •Mullerian Uterine anomalies as septate, bicornuate uterus.
- •Fibroid uterus.
- •Coagulopathy.
- •Medical disorder that contraindicate induction of abortion.
- •Allergy to misoprostol or letrozole.
Arms & Interventions
letrozole then misoprostol
description:letrozole 2.5 mg each 12hours for 2 days at home followed by misoprostol 800mcg vaginally at hospital repeated after 4 hours if needed
Intervention: letrozole (Drug)
placebo then misoprostol
Description:placebo each 12 hours for 2days at home followed by 800mcg misoprostol vaginally at hospital and repeat dose after 4 hours if needed
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
Complete abortion
Time Frame: 6 hours
incidence of complete abortion without the need of surgical evacuation among 110patients in which 55 of patients took letrozole before misoprostol and the other 55 patients took placebo before misoprostol
Secondary Outcomes
- surgical evacuation(6 hours)
Investigators
Shereen Rady Abou El-fetouh
principal investigator
Ain Shams University