Use of Letrozole Pretreatment With Misoprostol for First-Trimester Medical Abortion

NCT ID: NCT02401425

Last Updated: 2015-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 423 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2015-09-30

Brief Summary

The purpose of this study is to compare the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of first trimester pregnancy.

Detailed Description

Primary outcome:

Incidence of complete miscarriage (complete expulsion of the products of conception with no need for surgical intervention within one week from the first dose of misoprostol)

Secondary outcome:

Need for surgical evacuation of the products of conception

• Incomplete expulsion of the products of conception (incomplete miscarriage).
• Considerable bleeding necessitating immediate surgical evacuation. Maternal morbidity
• Major side effects (Sepsis, considerable vaginal bleeding leading to hemodynamic instability or necessitating blood transfusion)
• Minor side effects (fever, rigors, nausea, vomiting) Patient's compliance and adherence to treatment Hemoglobin and hematocrit deficit

Conditions

Complete Miscarriage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

letrozole

Women will receive three tablets of letrozole(FemaraR, NOVARTIS) 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 4 tablets of vaginal misoprostol (200 mcg) (MisotacR,SIGMA)soaked with saline every three hours up to maximum 2 doses.

Group Type: ACTIVE_COMPARATOR

Letrozole

Intervention Type: DRUG

Misoprostol

Intervention Type: DRUG

placebo

Women will receive three tablets of placebo 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 4 tablets of vaginal misoprostol (200 mcg) (MisotacR,SIGMA)soaked with saline every three hours up to maximum 2 doses.

Group Type: PLACEBO_COMPARATOR

Misoprostol

Intervention Type: DRUG

Placebo

Intervention Type: OTHER

Interventions

Letrozole

Intervention Type: DRUG

Misoprostol

Intervention Type: DRUG

Placebo

Intervention Type: OTHER

Other Intervention Names

femara; Misotac; Misotec; Cytotec

Eligibility Criteria

Inclusion Criteria

• Maternal age more than 18 years old (age of legal consent).
• Gestational age less than 13 weeks.
• Hemoglobin >10 g/dL.
• BMI between 25 kg/m2 and 35 kg/m2.
• Missed abortion.
• Living fetus with multiple congenital malformations incompatible with life.

Exclusion Criteria

• Maternal age less than 18 years old.
• Gestational age more than 12 weeks.
• Hemoglobin <10 g/dL.
• 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.
• Allergy to misoprostol or letrozole.
• Medical disorder that contraindicate induction of abortion (e.g. heart failure).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed S Sweed, MD

Lecturer of obstetrics and gynaecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain Shams University Maternity Hospital

Cairo, , Egypt

Countries

Egypt

Other Identifiers

1984

Identifier Type: -

Identifier Source: org_study_id