Letrozole Pretreatment With Misoprostol Induction of Abortion in First Trimester Missed Abortion

Shereen Rady Abou El-fetouh

Status and phase: Unknown; Phase 4

Conditions: Missed Abortion

Treatments: Drug: placebo; Drug: letrozole

Study type: Interventional

Funder types: Other

Identifiers

NCT04590482

Letrozole /pretreatment

Details and patient eligibility

About

this study will compare the efficacy of using letrozole pre treatment before misoprostol versus using misoprostol only in the induction of first trimester missed abortion.

Full description

Intervention type: drug

Intervention name: letrozole then misoprostol

Description :letrozole 2.5mg twice per day for 2days then misoprostol 800mcg for all patients to induce abortion

Arm group label:study group

Intervention type :drug

Intervention name:placebo then misoprostol

Description : placebo for 2days then 800mcg misoprostol to all patients to induce abortion

Arm group label: control group

Enrollment: 110 estimated patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Maternal age more than 18 years old.
2. Gestational age less than 13 weeks confirmed by ultrasound scan on day 1 of the study.
3. Hemoglobin >10 g/dl
4. Missed abortion

Exclusion criteria

1. Mullerian Uterine anomalies as septate, bicornuate uterus.

2. Fibroid uterus.

3. Coagulopathy.

4. Medical disorder that contraindicate induction of abortion.

5. Allergy to misoprostol or letrozole.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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110 participants in 2 patient groups, including a placebo group

letrozole then misoprostol

Experimental group

Description:

description:letrozole 2.5 mg each 12hours for 2 days at home followed by misoprostol 800mcg vaginally at hospital repeated after 4 hours if needed

Treatment:

Drug: letrozole

placebo then misoprostol

Placebo Comparator group

Description:

Description:placebo each 12 hours for 2days at home followed by 800mcg misoprostol vaginally at hospital and repeat dose after 4 hours if needed

Treatment:

Drug: placebo