NCT03614312

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

March 5, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

April 17, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 3, 2018

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2021

Completed
Last Updated

December 20, 2023

Status Verified

December 1, 2023

Enrollment Period

3.7 years

First QC Date

March 5, 2018

Last Update Submit

December 18, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

BMI 18-25 Pregnant Women

BMI 18-25 less than 36 weeks pregnant

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72202, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Placenta, umbilical cord, and cord blood

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2018

First Posted

August 3, 2018

Study Start

April 17, 2018

Primary Completion

December 22, 2021

Study Completion

December 22, 2021

Last Updated

December 20, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)