Letrozole Pretreatment With Misoprostol Induction of Abortion In First-Trimester Missed Miscarriage

December 30, 2019 updated by: Ahmed Samy aly ashour, Cairo University

Letrozole Pretreatment With Misoprostol for Induction of Abortion In First-Trimester Missed Miscarriage Among Women With One or More Previous Cesarean Deliveries.: A Randomized Controlled Trial

This study compares the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of first-trimester pregnancy among women with one or more previous cesarean deliveries.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Gestational age less than 64 days gestation (<9 wks).
  • Hemoglobin >10 g/dL.
  • BMI between 18.5 kg/m2 and 25 kg/m2.
  • Missed abortion.
  • previous one or more cesarean delivaries

Exclusion Criteria:

  • Molar pregnancy.
  • Fibroid uterus.
  • Uterine anomalies.
  • Coagulopathy.
  • Medical disorder that contraindicate induction of abortion (e.g. heart failure).
  • Previous attempts for induction of abortion in the current pregnancy.
  • Allergy to misoprostol or letrozole.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: study group
3 tablets of Letrozole 2.5 mg will be given as single daily dose, 7.5 mg per day for two days at home and the third dose will be given on admission to hospital on day 3 and will be followed by vaginal misoprostol 800 mcg every three hours up to maximum two doses.
Drug: letrozole then misoprostol

Drug: Letrozole 2.5mg total dose 7.5 mg per day for 3 days

Drug: Misoprostol Misoprosrol 800mcg will be given to all patients for induction of abortion
Placebo Comparator: control group
three tablets of placebo will be given as a single daily dose, for two days at home and will be admitted on day 3 and continue treatment with misoprostol 800 mcg every three hours up to maximum two doses
Drug: placebo then misoprostol

Drug: Placebo placebo for 3 days

Drug: Misoprostol Misoprosrol 800mcg will be given to all patients for induction of abortion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
induction to abortion time
Time Frame: 6 hours
induction to abortion time
6 hours
Incidence of complete miscarriage
Time Frame: 6 hours
Incidence of complete miscarriage
6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for surgical evacuation of the products of conception
Time Frame: 6 hours
Need for surgical evacuation of the products of conception
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 5, 2020

Primary Completion (Anticipated)

April 5, 2020

Study Completion (Anticipated)

April 10, 2020

Study Registration Dates

First Submitted

December 30, 2019

First Submitted That Met QC Criteria

December 30, 2019

First Posted (Actual)

January 2, 2020

Study Record Updates

Last Update Posted (Actual)

January 2, 2020

Last Update Submitted That Met QC Criteria

December 30, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • letrozole pretreatment

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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