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Clinical Trials/NCT03489564
NCT03489564
Completed
Not Applicable

The Effect of Physical Activity on in Vivo and in Vitro Mitochondrial Capacity in Pregnant Women

Pennington Biomedical Research Center1 site in 1 country20 target enrollmentMarch 19, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy Related
Sponsor
Pennington Biomedical Research Center
Enrollment
20
Locations
1
Primary Endpoint
Infant in vitro mitochondrial capacity (by oxygen consumption rate)
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 19, 2018
End Date
February 11, 2020
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Leanne Redman

Associate Professor

Pennington Biomedical Research Center

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Infant in vitro mitochondrial capacity (by oxygen consumption rate)

Time Frame: 1 day

Infant in vitro mitochondrial capacity measured by oxygen consumption rates in umbilical cord derived mesenchymal stem cells at delivery

Secondary Outcomes

  • Relationship between in vivo mitochondrial capacity and maternal in vitro mitochondrial capacity (by oxygen consumption rate)(About 15 weeks)
  • Relationship between in vivo mitochondrial capacity and infant in vitro mitochondrial capacity (by oxygen consumption rates)(About 20 weeks)

Study Sites (1)

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