Mitochondrial Capacity in Pregnant Women

NCT ID: NCT03489564

Last Updated: 2022-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-19

Study Completion Date

2020-02-11

Brief Summary

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This Pilot \& Feasibility study will test the hypothesis that pregnant women who are more active will have better functioning mitochondria in vivo (higher ATPmax, via 31P-MRS), which will be positively related to maternal and infant mitochondrial function in vitro (higher oxygen consumption rates in primary myotubes and umbilical cord derived mesenchymal stem cells, respectively). Twenty pregnant women (10 active and 10 sedentary) will be recruited in the first trimester of pregnancy determined from self-reported physical activity and assessment by activity monitors. Placental biospecimens will be collected during delivery for other molecular mitochondrial analyses.

Detailed Description

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Conditions

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Pregnancy Related Physical Activity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Active

Physically active will be defined by self-report and confirmed by step counts \>8,000 per day from activity monitoring.

Active

Intervention Type BEHAVIORAL

No behavioral intervention included but the exposure is level of physical activity. Individuals in the Active group will be categorized by their own routine physical activity levels.

Sedentary

Sedentary lifestyle will be defined by self-report and confirmed by step counts \<5,000 per day from activity monitoring.

Sedentary

Intervention Type BEHAVIORAL

No behavioral intervention included but the exposure is level of physical activity. Individuals in the Sedentary group will be categorized by their own routine physical activity levels.

Interventions

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Active

No behavioral intervention included but the exposure is level of physical activity. Individuals in the Active group will be categorized by their own routine physical activity levels.

Intervention Type BEHAVIORAL

Sedentary

No behavioral intervention included but the exposure is level of physical activity. Individuals in the Sedentary group will be categorized by their own routine physical activity levels.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Pregnant female
* BMI between 18.5 kg/m2 and 30.0 kg/m2 prior to the current pregnancy (determined by self report and confirmation of pregravid BMI of the index pregnancy from the prenatal record)
* Medically cleared for participation in the study by primary care obstetrician or midwife
* Medically cleared for participation by the Medical Investigator
* Medical record release (prenatal record, hospital delivery record) for study staff to access information in the medical record related to the current and if applicable, the prior pregnancy.

Exclusion Criteria

* Risk of early delivery (eg. history of preterm birth, spontaneous abortion, evidence of gestational hypertension (SBP \>160 mmHg \& DBP \>110 mmHg) or pre-eclampsia in the current pregnancy)
* History of intrauterine growth-restriction
* Persistent second- or third-trimester bleeding
* Placenta previa after 26 weeks gestation
* Incompetent cervix or cerclage
* Severe anemia
* High-order pregnancy (e.g. triplets)
* Family history of diabetes
* Heart or lung disease
* HIV or AIDS (self-reported)
* Individuals with contraindication to magnetic resonance spectroscopy such as having magnetic metallic objects in their body
* Unwillingness for placental biospecimens to be collected at delivery
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Pennington Biomedical Research Center

OTHER

Sponsor Role lead

Responsible Party

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Leanne Redman

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Leanne M Redman, PhD

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Locations

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Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status

Countries

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United States

Related Links

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http://www.pbrc.edu/clinical-trials/?studyid=260

Pennington Biomedical Research Center website description and webscreener survey

Other Identifiers

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PBRC 2017-065

Identifier Type: -

Identifier Source: org_study_id

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