Letrozole Pretreatment With Misoprostol for Second-Trimester Medical Abortion

Miscarriage Clinical Trial

Official title:

A Prospective Double-Blind, Randomized, Placebo-Controlled Trial on the Use of Letrozole Pretreatment With Misoprostol for Second-Trimester Medical Abortion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02405156
• Other study ID #: 305172
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 16, 2015
• Last updated: January 25, 2017
• Start date: March 2015
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Miscarriage

Intervention

Drug:
• Letrozole

• Placebo

• Misoprostol

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of induction of abortion		24 hours
Secondary	The incidence of need for surgical evacuation of placenta.		24 hours
Secondary	Hemoglobin change		24 hours
Secondary	Maternal morbidity		24 hours
Secondary	Success of induction of abortion	number of participants with Success of induction of abortion	24 hours
Secondary	Hematocrit change		24 hours