Letrozole Pretreatment With Misoprostol Versus Misoprostol Alone in Missed Abortion

Missed Abortion 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: Not yet recruiting

Administrative data

• NCT number: NCT04217265
• Other study ID #: letrozole
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: January 5, 2020
• Est. completion date: April 10, 2020

Study information

• Verified date: January 2020
• 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.

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

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.

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.

• Scared uterus (previous myomectomy, cesarean section, hysterectomy and ruptured uterus).

Related Conditions & MeSH terms

• Abortion, Missed
• Missed Abortion

Intervention

Drug:
• Letrozole then misoprostol
total dose 5 mg per day for 3 days then Misoprosrol 800mcg will be given to all patients for induction of abortion
• placebo then misoprostol
placebo tablets for 3 days then 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	complete abortion rate	Incidence of complete miscarriage	9 hours
Primary	time from induction to abortion	induction to abortion time interval	9 hours
Secondary	Need for surgical evacuation of the products of conception	how many women will undergo dilatation and curettage after failed medical induction of abortion	9 hours