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

Phase 2

Completed

• Conditions: Complete Miscarriage
• Interventions: Drug: Letrozole; Other: Placebo; Drug: Misoprostol

• Registration Number: NCT02401425
• Lead Sponsor: Ain Shams University

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

Study Timeline

• Study First Submitted: 2015-02-25
• Study Start: 2015-03
• Study First Submitted QC: 2015-03-24
• Study First Posted: 2015-03-27
• Status Verified: 2015-09
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-27
• Last Update Posted: 2015-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 423

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
letrozole	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.
placebo	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.
letrozole	Misoprostol	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.
placebo	Misoprostol	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.

Primary Outcome Measures

Name	Time	Method
Incidence of complete abortion	1 week	complete expulsion of the products of conception with no need for surgical intervention within one week from the first dose of misoprostol

Secondary Outcome Measures

Name	Time	Method
Need for surgical evacuation of the products of conception	1 week	Need for surgical evacuation of the products of conception; * Incomplete expulsion of the products of conception (incomplete miscarriage).; * Considerable bleeding necessitating immediate surgical evacuation.
Hemoglobin and hematocrit deficit	1 week
Maternal morbidity	1 week	Maternal morbidity; * Major side effects (Sepsis, considerable vaginal bleeding leading to hemodynamic instability or necessitating blood transfusion); * Minor side effects (fever, rigors, nausea, vomiting)

Trial Locations

Locations (1)

Ain Shams University Maternity Hospital; 🇪🇬 Cairo, Egypt