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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03628625
Other study ID # 0005
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


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
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