Termination of Early Pregnancy in Scarred Uterus With Lletrozole and Misoprostol Compared to Misoprostol Alone

September 23, 2021 updated by: Ahmed Elsayed Aref

Termination of Early Pregnancy in Scarred Uterus With Letrozole and Misoprostol Compared to Misoprostol Alone

Termination of early pregnancy in scarred uterus with letrozole and misoprostol compared to Misoprostol alone

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1

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

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Termination of early pregnancy in scarred uterus with letrozole and misoprostol compared to Misoprostol alone

Description

Inclusion Criteria:

  • Minimum age of 18 years for mother.

    • Non-viable fetus (missed abortion or blighted ovum) in the 1st trimester of pregnancy evidenced by criteria for diagnosis by TVS .
    • Previous C.S or Myomectomy (1 or more )
    • lack of any maternal diseases such as: heart disease, asthma, history of thromboembolism, cancer, renal failure, and liver diseases.

Exclusion Criteria:

  • * Medical problem in patient

    • Emergency conditions which need intervention .
    • History of allergy to misoprostol or letrozole drugs.

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Missed abortion received letrozole then misoprostol
Drug: Letrozole 2.5mg
Missed abortion received letrozole then misoprostol
Missed abortion received misoprostol alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete abortion of early pregnancy with letrozole then misoprostol
Time Frame: 6 months
Letrozole increase cervical ripening
6 months

Collaborators and Investigators

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

Sponsor

Ahmed Elsayed Aref

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)

October 1, 2021

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

August 1, 2022

Study Registration Dates

First Submitted

September 23, 2021

First Submitted That Met QC Criteria

September 23, 2021

First Posted (Actual)

October 5, 2021

Study Record Updates

Last Update Posted (Actual)

October 5, 2021

Last Update Submitted That Met QC Criteria

September 23, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-21-09-07

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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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