Mitochondrial Capacity in Pregnant Women

Completed

• Conditions: Physical Activity; Pregnancy Related
• Interventions: Behavioral: Active; Behavioral: Sedentary

• Registration Number: NCT03489564
• Lead Sponsor: Pennington Biomedical Research Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-19
• Study First Submitted: 2018-03-29
• Study First Submitted QC: 2018-03-29
• Study First Posted: 2018-04-05
• Primary Completion: 2020-02-11
• Study Completion: 2020-02-11
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-26
• Last Update Posted: 2022-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Infant in vitro mitochondrial capacity (by oxygen consumption rate)	1 day	Infant in vitro mitochondrial capacity measured by oxygen consumption rates in umbilical cord derived mesenchymal stem cells at delivery

Secondary Outcome Measures

Name	Time	Method
Relationship between in vivo mitochondrial capacity and maternal in vitro mitochondrial capacity (by oxygen consumption rate)	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
Relationship between in vivo mitochondrial capacity and infant in vitro mitochondrial capacity (by oxygen consumption rates)	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

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States