Mitochondrial Capacity in Pregnant Women

NCT03489564 | Completed

• 1 other identifier: PBRC 2017-065
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related; Physical Activity

Keywords

Pregnancy; Mitochondrial metabolism; Placenta

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  About 20 weeks

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

  About 15 weeks

Study Arms (2)

Active

Physically active will be defined by self-report and confirmed by step counts \>8,000 per day from activity monitoring.

Behavioral: Active

Sedentary

Sedentary lifestyle will be defined by self-report and confirmed by step counts \<5,000 per day from activity monitoring.

Behavioral: Sedentary

Interventions

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.

Active

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.

Sedentary

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Links

• Pennington Biomedical Research Center website description and webscreener survey

Biospecimen

Retention: SAMPLES WITH DNA

Placental biospecimens (placenta, umbilical cord, cord blood). Leg muscle tissue.

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Leanne M Redman, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: April 5, 2018
• Study Start: March 19, 2018
• Primary Completion: February 11, 2020
• Study Completion: February 11, 2020
• Last Updated: September 27, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)