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Mitochondrial Capacity in Pregnant Women (Mito Moms)

Pennington Biomedical Research Center logo

Pennington Biomedical Research Center

Status

Completed

Conditions

Physical Activity
Pregnancy Related

Treatments

Behavioral: Active
Behavioral: Sedentary

Study type

Observational

Funder types

Other

Identifiers

NCT03489564
PBRC 2017-065

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

Active
Description:
Physically active will be defined by self-report and confirmed by step counts \>8,000 per day from activity monitoring.
Treatment:
Behavioral: Active
Sedentary
Description:
Sedentary lifestyle will be defined by self-report and confirmed by step counts \<5,000 per day from activity monitoring.
Treatment:
Behavioral: Sedentary

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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