Mitochondrial Capacity in Pregnant Women

Physical Activity Clinical Trial

— Mito Moms  

Official title:

The Effect of Physical Activity on in Vivo and in Vitro Mitochondrial Capacity in Pregnant Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03489564
• Other study ID #: PBRC 2017-065
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Physical Activity
• Pregnancy Related

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

External Links

•   Pennington Biomedical Research Center website description and webscreener survey