NCT05067309

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 5, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

October 5, 2021

Status Verified

September 1, 2021

Enrollment Period

6 months

First QC Date

September 23, 2021

Last Update Submit

September 23, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Complete abortion of early pregnancy with letrozole then misoprostol

    Letrozole increase cervical ripening

    6 months

Study Arms (2)

Missed abortion received letrozole then misoprostol

Drug: Letrozole 2.5mg

Missed abortion received misoprostol alone

Interventions

Missed abortion received letrozole then misoprostol

Missed abortion received letrozole then misoprostol

Eligibility Criteria

Sexfemale
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • \* Medical problem in patient
  • Emergency conditions which need intervention .
  • History of allergy to misoprostol or letrozole drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ahmed Elsayed Aref

Sohag, Egypt

Location

Ahmed Elsayed Aref

Sohag, Egypt

Location

MeSH Terms

Interventions

Letrozole

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ahmed Elsayed Aref

Study Record Dates

First Submitted

September 23, 2021

First Posted

October 5, 2021

Study Start

October 1, 2021

Primary Completion

April 1, 2022

Study Completion

August 1, 2022

Last Updated

October 5, 2021

Record last verified: 2021-09

Locations