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

October 5, 2018 updated by: Dr- dina yahia mansour, Ain Shams Maternity Hospital

Letrozole Pretreatment With Misoprostol for Induction of Abortion In First-Trimester Missed Miscarriage: A Randomized Controlled Trial

This study compares the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of first trimester pregnancy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

According to the American college of obstetricians and gynecologists (2005), medical abortion is an acceptable alternative for surgical procedures in pregnant women with gestational age of less than 49 days based on the last menstrual period

Oral or vaginal misoprostol causes complete abortion in almost 85% of cases within seven days before the 12th week

letrozole administration with misoprostol raises the rate of complete abortion

Hypothesis:

In women with missed miscarriage in the first trimester undergoing induction of abortion pre-treatment with letrozole before misoprostol may lead to abortion rate similar to misoprostol alone.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Ain Shams University, Maternity Hospital
        • Contact:
          • Dina Mansour

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

Yes

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.

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
  • 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: Misoprostol
Misoprosrol 800mcg will be given to all patients for induction of abortion
Drug: Letrozole 2.5mg
total dose 7.5 mg per day for 3 days
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: Misoprostol
Misoprosrol 800mcg will be given to all patients for induction of abortion
Drug: Placebo
Folic acid for 3 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of complete miscarriage
Time Frame: 6 hours
6 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Need for surgical evacuation of the products of conception
Time Frame: 6 hours
6 hours
Incidence of Septic Abortion
Time Frame: 1 week
1 week

Collaborators and Investigators

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

Sponsor

Ain Shams Maternity Hospital

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 (Actual)

September 10, 2018

Primary Completion (Anticipated)

December 5, 2018

Study Completion (Anticipated)

December 10, 2018

Study Registration Dates

First Submitted

May 10, 2018

First Submitted That Met QC Criteria

August 10, 2018

First Posted (Actual)

August 14, 2018

Study Record Updates

Last Update Posted (Actual)

October 9, 2018

Last Update Submitted That Met QC Criteria

October 5, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0005 (VACHS)

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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