Letrozole Pretreatment With Misoprostol Induction of Abortion in First Trimester Missed Abortion

October 27, 2020 updated by: Shereen Rady Abou El-fetouh

Use of Letrozole Pretreatment With Misoprostol for Induction of Abortion in First Trimester Missed Abortion

this study will compare the efficacy of using letrozole pre treatment before misoprostol versus using misoprostol only in the induction of first trimester missed abortion.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Intervention type: drug

Intervention name: letrozole then misoprostol

Description :letrozole 2.5mg twice per day for 2days then misoprostol 800mcg for all patients to induce abortion

Arm group label:study group

Intervention type :drug

Intervention name:placebo then misoprostol

Description : placebo for 2days then 800mcg misoprostol to all patients to induce abortion

Arm group label: control group

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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 to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Maternal age more than 18 years old.
  2. Gestational age less than 13 weeks confirmed by ultrasound scan on day 1 of the study.
  3. Hemoglobin >10 g/dl
  4. Missed abortion

Exclusion Criteria:

  1. Mullerian Uterine anomalies as septate, bicornuate uterus.
  2. Fibroid uterus.
  3. Coagulopathy.
  4. Medical disorder that contraindicate induction of abortion.

  5. 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: letrozole then misoprostol
description:letrozole 2.5 mg each 12hours for 2 days at home followed by misoprostol 800mcg vaginally at hospital repeated after 4 hours if needed
Drug: letrozole
Letrozole 2.5 mg each 12 hours for 2 days followed by vaginal misoprostol 800 mcg for induction of abortion
Placebo Comparator: placebo then misoprostol
Description:placebo each 12 hours for 2days at home followed by 800mcg misoprostol vaginally at hospital and repeat dose after 4 hours if needed
Drug: placebo
placebo given twice daily for 2 days followed by 800mcg misoprostol vaginally to induce abortion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete abortion
Time Frame: 6 hours
incidence of complete abortion without the need of surgical evacuation among 110patients in which 55 of patients took letrozole before misoprostol and the other 55 patients took placebo before misoprostol
6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
surgical evacuation
Time Frame: 6 hours
surgical evacuation for the remnants of conception among 110 patients in which 55 took letrozole before misoprostol and other 55 patients who took placebo before misoprostol
6 hours

Collaborators and Investigators

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

Sponsor

Shereen Rady Abou El-fetouh

Investigators

  • Principal Investigator: shereen khedr, Ainshams 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)

November 15, 2020

Primary Completion (Anticipated)

March 16, 2021

Study Completion (Anticipated)

May 8, 2021

Study Registration Dates

First Submitted

August 23, 2020

First Submitted That Met QC Criteria

October 10, 2020

First Posted (Actual)

October 19, 2020

Study Record Updates

Last Update Posted (Actual)

October 29, 2020

Last Update Submitted That Met QC Criteria

October 27, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Letrozole /pretreatment

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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