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NCT04590482 Clinical Trial

Letrozole Pretreatment With Misoprostol Induction of Abortion in First Trimester Missed Abortion

Missed Abortion Clinical Trial

Official title:
Use of Letrozole Pretreatment With Misoprostol for Induction of Abortion in First Trimester Missed Abortion

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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Recruiting NCT03698734 - Evening Primrose Oil Efficacy in Second Trimester Abortion Phase 3
Terminated NCT01615224 - Repeated Doses of Misoprostol for Medical Treatment of Missed Miscarriage Phase 2/Phase 3
Completed NCT05216952 - Ulipristal Acetate for Use in Early Pregnancy Loss Phase 2
Recruiting NCT03081104 - Operative Hysteroscopy and Ultrasound Guided Vacuum Aspiration Versus Blind Vacuum Aspiration for the Treatment of Missed Abortion N/A
Completed NCT00892229 - Buccal Versus Vaginal Misoprostol in Surgical Termination of the First Trimester Missed Abortion in Erbil Phase 2
Active, not recruiting NCT04981457 - Comparative Study Between Combined Vaginal Misoprostol Phase 1
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Recruiting NCT02573051 - Termination Of Anembryonic Pregnancy Phase 2
Not yet recruiting NCT04215835 - Letrozole Pretreatment With Misoprostol Induction of Abortion In First-Trimester Missed Miscarriage Phase 4
Not yet recruiting NCT04217265 - Letrozole Pretreatment With Misoprostol Versus Misoprostol Alone in Missed Abortion Phase 4
Recruiting NCT04705324 - Dilation and Curettage Versus Operative Hysteroscopy for Missed Abortion N/A
Completed NCT02686840 - Sublingual Versus Vaginal Misoprostol In Medical Treatment of First Trimestric Missed Miscarriage Phase 3
Terminated NCT02342002 - Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled Trial Phase 4
Recruiting NCT01775917 - The Role of Uterine Artery Doppler Parameters in the Management of Retained Products of Conception. N/A
Active, not recruiting NCT04593108 - Misoprostol With or Without Letrozole in Treatment of Missed Miscarriage