Placenta Development Study | NCT03614312

Studies
Placenta Development Study

NCT03614312

Sponsor

Arkansas Children's Hospital Research Institute

Status

Completed

Last Update Posted

Dec 20, 2023Actual

Enrollment

15Actual

Phase

Not provided

Conditions

Healthy

Interventions

Not provided

Countries

United States

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

Dec 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

Apr 17, 2018Actual

Primary Completion Date

Dec 22, 2021Actual

Completion Date

Dec 22, 2021Actual

First Submitted Date

Mar 5, 2018

First Submission Date that Met QC Criteria

Jul 30, 2018

First Posted Date

Aug 3, 2018Actual

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

Dec 18, 2023

Last Update Posted Date

Dec 20, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

This study will help us learn more about how the placenta develops.

Detailed Description

The primary purpose of this study is to understand the epigenetic signaling events in placental trophoblast development.

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

Retention

Enrollment

15Actual

Label	Type	Description	Intervention Names
BMI 18-25 Pregnant Women		BMI 18-25 less than 36 weeks pregnant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants that placental syncytial fusion involves epigenetic changes in histone modifications	Number of participants that histone acetyltransferases eszymes, CBP and p300 affect syncytial fusion	40 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI - 18-25 kg/m2
at least 18 years of age
singleton pregnancy
less than 36 weeks and plan to deliver in the Little Rock/North Little Rock Area

Exclusion Criteria:

Women with pre-existing medical conditions (e.g. diabetes, hypertension, pre-eclampsia, STD, gestational diabetes)
Women who are using recreational drugs, tobacco, or alcohol during their pregnancy.
Women who plan on keeping their placenta following delivery for non-medical reasons.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Pregnant

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arkansas Children's Nutrition Center		Little Rock	Arkansas	72202	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided