Letrozole Pretreatment With Misoprostol for Second-Trimester Medical Abortion

Ain Shams University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Miscarriage

Treatments: Drug: Placebo; Drug: Misoprostol; Drug: Letrozole

Study type: Interventional

Funder types: Other

Identifiers

NCT02405156

305172

Details and patient eligibility

About

To compare the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of pregnancy in second trimester abortion.

Full description

This prospective double-blind, randomized, clinical trial, will be conducted at Ain Shams University Maternity Hospital.

Patients fulfilling inclusion and exclusion criteria will be divided into two groups.

Group (A):

181 women will receive three tablets of letrozole (On December 28, 2005, the U.S. Food and Drug Administration approved letrozole tablets (Femara®, made by Novartis Pharmaceuticals Corp.) as a single dose, each tablet 2.5 mg (total dose 7.5 mg per day) for two days at home and will be told to bring back the empty packs. The third dose will be given on admission to hospital on day three and will be followed by 400 mcg vaginal misoprostol soaked with saline every three hours up to maximum five doses on Day 3.

Group (B):

181 women will receive three tablets of placebo (manufactured by Egyptian Group Company for drug industries) as a single dose, for two days at home and will be told to bring back the empty packs. The third dose will be given on admission to hospital on day three and will be followed by 400 mcg vaginal misoprostol soaked with saline every three hours up to maximum five doses on Day 3.

Data recording:

1. Duration of complete abortion.
2. Post abortion bleeding.
3. Incomplete delivery of the placenta necessitates evacuation under anesthesia.
4. Hemoglobin and hematocrit after 24 hours from abortion to estimate the decrease in hemoglobin level.
5. Recording maternal morbidities.
6. Patients that will receive 5 doses and did not abort till 24 hours from the first dose of misoprostol will be considered failed induction and will stop follow up without reporting outcome.

Enrollment: 400 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Maternal age more than 18 years old (age of legal consent).
• Gestational age between 12 weeks and 24 weeks.
• Hemoglobin >10 g/dL.
• BMI between 25 kg/m2 and 35 kg/m2.
• Miscarriage .
• Living fetus with multiple congenital malformations incompatible with life.
• PPROMs with drained liquor and parents are consenting for termination of pregnancy.

Exclusion criteria

• Maternal age less than 18 years old.
• Gestational age less than 12 weeks or more than 24 weeks.
• Hemoglobin <10 g/dL.
• Scared uterus (previous myomectomy, cesarean section, hysterectomy and ruptured uterus).
• Polyhydraminos.
• Anencephaly.
• Fibroid uterus.
• BMI less than 25kg/m2 and more than 35kg/m2.
• Coagulopathy.
• History or evidence of adrenal pathology.
• Previous attempts for induction of abortion in the current pregnancy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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400 participants in 2 patient groups, including a placebo group

letrozole + misoprostol

Experimental group

Description:

Women will receive three tablets of letrozole vaginal as a single dose, each tablet 2.5 mg (total dose 7.5 mg per day) for three days and will be followed by 200 mcg vaginal misoprostol or 100mcg vaginal misoprostol (according gestational age) soaked with saline every six hours up to maximum four doses.

Treatment:

Drug: Misoprostol

Drug: Letrozole

placebo + misoprostol

Placebo Comparator group

Description:

Women will receive three tablets of placebo vaginal as a single dose, for three days and will be followed by 200 mcg vaginal misoprostol or 100 mcg vaginal misoprostol (according gestational age) soaked with saline every six hours up to maximum four doses.

Treatment:

Drug: Misoprostol

Drug: Placebo