Clinical trial NCT03489564: Mitochondrial Capacity in Pregnant Women
Official title: The Effect of Physical Activity on in Vivo and in Vitro Mitochondrial Capacity in Pregnant Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Related
Physical Activity
Keywords: Pregnancy
Mitochondrial metabolism
Placenta
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2018-04-05
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy women that are classified as either physically active or sedentary in early pregnancy.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Infant in vitro mitochondrial capacity (by oxygen consumption rate)
timeFrame: 1 day
Secondary outcomes:
measure: Relationship between in vivo mitochondrial capacity and infant in vitro mitochondrial capacity (by oxygen consumption rates)
timeFrame: About 20 weeks
measure: Relationship between in vivo mitochondrial capacity and maternal in vitro mitochondrial capacity (by oxygen consumption rate)
timeFrame: About 15 weeks
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Leanne M Redman, PhD
role: PRINCIPAL_INVESTIGATOR
References: