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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03489564
Other study ID # PBRC 2017-065
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 19, 2018
Est. completion date February 11, 2020

Study information

Verified date September 2022
Source Pennington Biomedical Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date February 11, 2020
Est. primary completion date February 11, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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
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.

Locations

Country Name City State
United States Pennington Biomedical Research Center Baton Rouge Louisiana

Sponsors (1)

Lead Sponsor Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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