Effectiveness of Pretreatment Letrozole Versus Misoprostol Alone in Missed Abortion

• Status: Not yet recruiting
• Trial end date: 2021-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

Background and Rationale Abortion accounts for about 8% of maternal mortality worldwide. Surgical intervention is the definitive treatment for abortion but it is invasive. Misoprostol, a PG E1 analogue, is exten¬sively used for induction of abortion with success rate less than 90%. Estrogen is important in the maintenance of pregnancy & aromatase enzyme is essential for its production. Letrozole is an aromatase inhibitor. So we assume that suppression of serum estradiol by letrozole will facilitate termination of pregnancy.

Objectives :

To compare the effect of a combination of letrozole with misoprostol versus misoprostol alone in successful induction of medical abortion.

Study population & Sample size 150 women will be recruited. Women included will be > 18 years with singleton pregnancy of gestational age ≤ 20 weeks having missed abortion. They will be excluded if they have prior CS, twin pregnancy, allergy to letrozole or liver problems.

Study Design :

A randomized controlled trial in which patients will be divided into 2 groups; case group & control group. Each group will contain 75 patients.

Methods :

Case group will receive pretreatment letrozole 12.5 mg for 2 days while control group will receive only misoprostol. Both groups will receive misoprostol in a dosage according to the ACOG guidelines based on gestational age.

Possible Risk (s) to study population :

Major risks (Sepsis, considerable vaginal bleeding leading to hemodynamic instability or necessitating blood transfusion). Minor risks (Nausea, diarrhea, headache, weakness, hot flushes).

Outcome parameter (s):

Successful medical abortion i.e. complete abortion with no need for surgical curettage within one week from the 1st dose of misoprostol.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cairo University
• Treatments: Letrozole; Misoprostol

Criteria

Inclusion Criteria:

• Singleton pregnancy.

• Primigravida or multigravida.

• Gestational age ≤ 20 weeks.

• Missed abortion.

Exclusion Criteria:

• Maternal age < 18 years.

• Twin pregnancy.

• Previous cesarean section.

• Allergy to letrozole or misoprostol.

• Liver cirrhosis or severe liver impairment.