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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04590482
Other study ID # Letrozole /pretreatment
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date November 15, 2020
Est. completion date May 8, 2021

Study information

Verified date October 2020
Source Ain Shams University
Contact shereen khedr
Phone 01011304478
Email a.m.agdy@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 Intervention name:placebo then misoprostol Description : placebo for 2days then 800mcg misoprostol to all patients to induce abortion Arm group label: control group


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 110
Est. completion date May 8, 2021
Est. primary completion date March 16, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 42 Years
Eligibility Inclusion Criteria: 1. Maternal age more than 18 years old. 2. Gestational age less than 13 weeks confirmed by ultrasound scan on day 1 of the study. 3. Hemoglobin >10 g/dl 4. Missed abortion Exclusion Criteria: 1. Mullerian Uterine anomalies as septate, bicornuate uterus. 2. Fibroid uterus. 3. Coagulopathy. 4. Medical disorder that contraindicate induction of abortion. 5. Allergy to misoprostol or letrozole. -

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
letrozole
Letrozole 2.5 mg each 12 hours for 2 days followed by vaginal misoprostol 800 mcg for induction of abortion
placebo
placebo given twice daily for 2 days followed by 800mcg misoprostol vaginally to induce abortion

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Shereen Rady Abou El-fetouh

Outcome

Type Measure Description Time frame Safety issue
Primary Complete abortion 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 6 hours
Secondary surgical evacuation surgical evacuation for the remnants of conception among 110 patients in which 55 took letrozole before misoprostol and other 55 patients who took placebo before misoprostol 6 hours
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