Termination of Early Pregnancy in Scarred Uterus With Lle... | NCT05067309

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

NCT05067309

Sponsor

Ahmed Elsayed Aref

Status

Unknown status

Last Update Posted

Oct 5, 2021Actual

Enrollment

1Estimated

Phase

Not provided

Conditions

Termination of Early Pregnancy in Scarred Uterus

Interventions

Letrozole 2.5mg

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2021Estimated

Primary Completion Date

Apr 1, 2022Estimated

Completion Date

Aug 1, 2022Estimated

First Submitted Date

Sep 23, 2021

First Submission Date that Met QC Criteria

Sep 23, 2021

First Posted Date

Oct 5, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 23, 2021

Last Update Posted Date

Oct 5, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Missed abortion received letrozole then misoprostol			Drug: Letrozole 2.5mg
Missed abortion received misoprostol alone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Letrozole 2.5mg	Drug	Missed abortion received letrozole then misoprostol	Missed abortion received letrozole then misoprostol

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ahmed Elsayed Aref		Sohag			Egypt	Ahmed Elsayed Aref

Type	Date	Date Unknown
Release	Jun 25, 2022
Reset	Apr 28, 2023

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jun 25, 2022			Apr 28, 2023

Intervention Browse Module

MeSH Terms

ID	Term
D000077289	Letrozole

Ancestor Terms

ID	Term
D009570	Nitriles
D009930	Organic Chemicals
D014230	Triazoles
D001393	Azoles
D006573

Browse Leaves

Not provided

Browse Branches

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