Mitochondrial Capacity in Pregnant Women (Mito Moms)

The Effect of Physical Activity on in Vivo and in Vitro 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.

Study Overview

• Status: Completed
• Conditions: Physical Activity; Pregnancy Related
• Intervention / Treatment: Behavioral: Active; Behavioral: Sedentary

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Healthy women that are classified as either physically active or sedentary in early pregnancy.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship between in vivo mitochondrial capacity and infant in vitro mitochondrial capacity (by oxygen consumption rates)	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	About 20 weeks
Relationship between in vivo mitochondrial capacity and maternal in vitro mitochondrial capacity (by oxygen consumption rate)	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	About 15 weeks

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Investigators: Principal Investigator: Leanne M Redman, PhD, Pennington Biomedical Research Center

Publications and helpful links

Helpful Links

• Pennington Biomedical Research Center website description and webscreener survey

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2018
• Primary Completion (Actual): February 11, 2020
• Study Completion (Actual): February 11, 2020

Study Registration Dates

• First Submitted: March 29, 2018
• First Submitted That Met QC Criteria: March 29, 2018
• First Posted (Actual): April 5, 2018

Study Record Updates

• Last Update Posted (Actual): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Pregnancy; Placenta; Mitochondrial metabolism
• Other Study ID Numbers: PBRC 2017-065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No