Evaluation of Apelin-13 and Apelin-36 in Women With Recur... | NCT05205044

Studies
Evaluation of Apelin-13 and Apelin-36 in Women With Recurrent Pregnancy Loss

NCT05205044

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Feb 14, 2023Actual

Enrollment

88Actual

Phase

Not provided

Conditions

Recurrent Pregnancy Loss

Interventions

Apelin-13, Apelin-36

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 23, 2022Actual

Primary Completion Date

Jan 30, 2023Actual

Completion Date

Jan 30, 2023Actual

First Submitted Date

Jan 11, 2022

First Submission Date that Met QC Criteria

Jan 11, 2022

First Posted Date

Jan 24, 2022Actual

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

Feb 12, 2023

Last Update Posted Date

Feb 14, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Lower Apelin levels are associated with hypertensive disorders with pregnancy, yet no studies investigated its levels in recurrent pregnancy loss

Detailed Description

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

88Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Recurrent pregnancy loss			Diagnostic Test: Apelin-13, Apelin-36
Healthy			Diagnostic Test: Apelin-13, Apelin-36

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Apelin-13, Apelin-36	Diagnostic Test	Serum levels of Apelin-13 and Apelin-36	Healthy Recurrent pregnancy loss

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Apelin-13 and Apelin-36	Serum levels of Apelin-13 and Apelin-36	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pregnant women in first trimester
negative antiphospholipid markers
normal karyotype

Exclusion Criteria:

multiple pregnancy
fetal malformations
maternal diseases
smoking or alcohol use
history of or risk factors for preterm labor

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Pregnant females in first trimester

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain Shams University Maternity Hospital		Cairo	Cairo/القاهرة	71350	Egypt
AinShams Maternity Hospital

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided