NCT03412981

Brief Summary

To date very little research has been conducted on pregnant mothers. Research shows that mothers with obesity and gestational diabetes have children who have a higher risk of later developing obesity and diabetes compared to children born to non-obese mothers but the mechanisms are not known. The maternal environment may place these babies at greater risk and it is possible that fat tissue (adipose tissue) releases many chemicals (adipokines and inflammatory cytokines) which may have an impact on the baby. Mothers who have greater amounts of adipose tissue most likely release these adipokines into the baby and it may affect the baby's body composition and/or health. This project will establish if there is a relationship between obesity and adipose tissue inflammation in pregnant mothers, and if there is a link between inflammation and the child's body composition. We will recruit mothers with low risk pregnancies already schedule for a C section at about 36 wk. We will do initial testing at 36 wk, adipose tissue collection at delivery, and conduct post testing at 1 month postpartum on the mother and the baby.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2017

Typical duration for all trials

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

December 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 29, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
Last Updated

November 3, 2020

Status Verified

October 1, 2020

Enrollment Period

2.3 years

First QC Date

January 20, 2018

Last Update Submit

October 31, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • TNFa

    TNFa, IL-6, IL-4, IL-13

    at delivery

Secondary Outcomes (5)

  • body fat

    after delivery

  • IL-6

    at delivery

  • IL-4

    at delivery

  • IL-13

    at delivery

  • baby weight

    at birth

Interventions

we will be collecting data on a cohort of pregnant mothers

Eligibility Criteria

Age21 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsEligibility is based on being able to get pregnant
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Recruiting from women who will deliver their babies at Women and Children's hospital in Columbia, MO

You may qualify if:

  • Mothers who have low risk pregnancies (21-40 years) and are already scheduled to have a C-section. BMI ≤ 40 kg/m2

You may not qualify if:

  • We will exclude emergency C-sections
  • Subjects will have had a screening ultrasound that demonstrated the absence of congenital anomalies as part of routine prenatal care
  • Mothers with high risk pregnancy
  • BMI \> 40 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Misouri

Columbia, Missouri, 65211, United States

Location

University of Missouri

Columbia, Missouri, 65211, United States

Location

Study Officials

  • Jill Kanaley, PhD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 20, 2018

First Posted

January 29, 2018

Study Start

December 1, 2017

Primary Completion

March 31, 2020

Study Completion

October 31, 2020

Last Updated

November 3, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations