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

Cairo University (CU)

Status and phase: Unknown; Phase 4

Conditions: Missed Abortion

Treatments: Drug: placebo then misoprostol; Drug: letrozole then misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT04215835

letrozole pretreatment

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

study group

Experimental group

Description:

3 tablets of Letrozole 2.5 mg will be given as single daily dose, 7.5 mg per day for two days at home and the third dose will be given on admission to hospital on day 3 and will be followed by vaginal misoprostol 800 mcg every three hours up to maximum two doses.

Treatment:

Drug: letrozole then misoprostol

control group

Placebo Comparator group

Description:

three tablets of placebo will be given as a single daily dose, for two days at home and will be admitted on day 3 and continue treatment with misoprostol 800 mcg every three hours up to maximum two doses

Treatment:

Drug: placebo then misoprostol