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

Missed Abortion Clinical Trial

Official title:

Letrozole Pretreatment With Misoprostol for Induction of Abortion In First-Trimester Missed Miscarriage Among Women With One or More Previous Cesarean Deliveries.: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04215835
• Other study ID #: letrozole pretreatment
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: January 5, 2020
• Est. completion date: April 10, 2020

Study information

• Verified date: December 2019
• Source: Cairo University
• Contact: AHMED SAMY
• Phone: +201100681167
• Email: ahmedsamy8233[@]gmail.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 among women with one or more previous cesarean deliveries.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: April 10, 2020
• Est. primary completion date: April 5, 2020
• Accepts healthy volunteers: No
• 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.

• previous one or more cesarean delivaries

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
• Missed Abortion

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	induction to abortion time	induction to abortion time	6 hours
Primary	Incidence of complete miscarriage	Incidence of complete miscarriage	6 hours
Secondary	Need for surgical evacuation of the products of conception	Need for surgical evacuation of the products of conception	6 hours