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Completed

NCT Number: NCT03489564

Mitochondrial Capacity in Pregnant Women

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.

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Key information

Conditions

Pregnancy Related Behavior Motor Activity Physical Activity

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACTIVE

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

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.

Primary outcomes

  1. 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

  1. Relationship between in vivo mitochondrial capacity and infant in vitro mitochondrial capacity (by oxygen consumption rates)

    Time frame: About 20 weeks

    Relationship between in vivo and in vitro mitochondrial capacity will be measured with in vivo mitochondrial capacity measured by 31P-MRS and infant in vitro mitochondrial capacity measured by oxygen consumption rates in umbilical cord derived mesenchymal stem cells

  2. Relationship between in vivo mitochondrial capacity and maternal in vitro mitochondrial capacity (by oxygen consumption rate)

    Time frame: About 15 weeks

    Relationship between in vivo and in vitro mitochondrial capacity will be measured with in vivo mitochondrial capacity measured by 31P-MRS and maternal in vitro mitochondrial capacity measured by oxygen consumption rates in maternal primary myotubes

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Official study title

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

Acronym: Mito Moms

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 5, 2018
Registry last updated
Sep 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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