Letrozole Pretreatment With Misoprostol fInduction of Abortion In First-Trimester Missed Miscarriage

Miscarriage Clinical Trial

Official title:

Letrozole Pretreatment With Misoprostol for Induction of Abortion In First-Trimester Missed Miscarriage: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03628625
• Other study ID #: 0005
• Status: Recruiting
• Phase: Phase 2
• Start date: September 10, 2018
• Est. completion date: December 10, 2018

Study information

• Verified date: October 2018
• Source: Ain Shams Maternity Hospital
• Contact: Dina Mansour
• Phone: +20100657
• Email: Dinayahiamansour[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study compares the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of first trimester pregnancy.

Description:

According to the American college of obstetricians and gynecologists (2005), medical abortion is an acceptable alternative for surgical procedures in pregnant women with gestational age of less than 49 days based on the last menstrual period

Oral or vaginal misoprostol causes complete abortion in almost 85% of cases within seven days before the 12th week

letrozole administration with misoprostol raises the rate of complete abortion

Hypothesis:

In women with missed miscarriage in the first trimester undergoing induction of abortion pre-treatment with letrozole before misoprostol may lead to abortion rate similar to misoprostol alone.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 10, 2018
• Est. primary completion date: December 5, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Gestational age less than 64 days gestation (<9 wks).

• Hemoglobin >10 g/dL.

• BMI between 18.5 kg/m2 and 25 kg/m2.

• Missed abortion.

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.

Related Conditions & MeSH terms

• Abortion, Missed
• Abortion, Spontaneous
• Miscarriage
• Missed Abortion

Intervention

Drug:
• Letrozole 2.5mg
total dose 7.5 mg per day for 3 days
• Placebo
Folic acid for 3 days
• Misoprostol
Misoprosrol 800mcg will be given to all patients for induction of abortion

Locations

Country	Name	City	State
Egypt	Ain Shams University, Maternity Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of complete miscarriage		6 hours
Secondary	Need for surgical evacuation of the products of conception		6 hours
Secondary	Incidence of Septic Abortion		1 week