Misoprostol With or Without Letrozole in Treatment of Missed Miscarriage

Missed Abortion Clinical Trial

Official title:

Study at Zagazig General Hospital

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04593108
• Other study ID #: Treatment of missedmiscarriage
• Status: Active, not recruiting
• Start date: January 15, 2019
• Est. completion date: November 15, 2020

Study information

• Verified date: October 2020
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Aim of study Compare the success rate of misoprostol with versus without letrozole as a pretreatment for medical termination of pregnancy during the first trimester.

Hypothesis:

Letrozole value as a pre-treatment medication for misoprostol in induction of abortion during the first trimester.

Research question:

Will letrozole- misoprostol protocol give better results than misoprostol- alone protocol in induction of abortion during the first trimester?

Description:

Aim of the Work

Compare the success rate of misoprostol with versus without letrozole as a pretreatment for medical termination of pregnancy during the first trimester.

Hypothesis:

Letrozole value as a pre-treatment medication for misoprostol in induction of abortion during the first trimester.

Research question:

Will letrozole- misoprostol protocol give better results than misoprostol- alone protocol in induction of abortion during the first trimester?

Primary outcome:

Complete abortion (complete expulsion of products of conception with no need for curettage) within one week from the first dose of misoprostol.

Secondary outcome:

• Curettage (surgical evacuation of the products of conception)

• Incomplete abortion (retained products of conception).

• Considerable bleeding that necessitates immediate evacuation.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 320
• Est. completion date: November 15, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Woman age more than 18 years old (age of legal consent).

• BMI ranges between 25 kg/m2 and 35 kg/m2.

• Gestational age of 63 days' gestation (or less).

• Missed abortion.

• Hemoglobin leve

Exclusion criteria:

• Woman age less than 18 years old.

• BMI less than 25 kg/m2 or more than 35 kg/m2.

• Gestational age more than 63 days' gestation.

• Molar pregnancy.

• Hemoglobin level less than 10 gm/dL.

• Fibroid uterus.

• Uterus with congenital anomalies.

• Previous attempts for induction of abortion in the current pregnancy.

• Coagulation defect i.e. coagulopathy.

• Contraindication for induction of abortion e.g. heart failure.

• Allergy to misoprostol or letrozole.

Related Conditions & MeSH terms

• Abortion, Missed
• Missed Abortion

Intervention

Device:
• Letrozole misoprostol
Letrozole give pretreatment of abortion by misoprostol

Drug:
• Misoprostol, placebo
Give placebo pretreatment of abortion by misoprostol

Locations

Country	Name	City	State
Egypt	Dalia Mohammed Al Sayed Zaki	Zagazig	Sharqia

Sponsors (2)

Lead Sponsor	Collaborator
Dr.Dalia Mohammed Al Sayed Zaki	Benha University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Lee VC, Ng EH, Yeung WS, Ho PC. Misoprostol with or without letrozole pretreatment for termination of pregnancy: a randomized controlled trial. Obstet Gynecol. 2011 Feb;117(2 Pt 1):317-23. doi: 10.1097/AOG.0b013e3182073fbf. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete abortion	Complete abortion (complete expulsion of products of conception with no need for curettage) within one week from the first dose of misoprostol.	1week

External Links

•   Misoprostol with or without letrozole pretreatment for termination of pregnancy: a randomized controlled trial