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Mitochondrial Capacity in Pregnant Women (Mito Moms)

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ClinicalTrials.gov Identifier: NCT03489564
Recruitment Status : Active, not recruiting
First Posted : April 5, 2018
Last Update Posted : October 28, 2019
Sponsor:
Information provided by (Responsible Party):
Leanne Redman, Pennington Biomedical Research Center

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.

Condition or disease Intervention/treatment
Pregnancy Related Physical Activity Behavioral: Active Behavioral: Sedentary

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Physical Activity on in Vivo and in Vitro Mitochondrial Capacity in Pregnant Women
Actual Study Start Date : March 19, 2018
Estimated Primary Completion Date : February 29, 2020
Estimated Study Completion Date : February 29, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Infant in vitro mitochondrial capacity (by oxygen consumption rate) [ Time Frame: 1 day ]
    Infant in vitro mitochondrial capacity measured by oxygen consumption rates in umbilical cord derived mesenchymal stem cells at delivery


Secondary Outcome Measures :
  1. Relationship between in vivo mitochondrial capacity and infant in vitro mitochondrial capacity (by oxygen consumption rates) [ Time Frame: About 20 weeks ]
    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

  2. Relationship between in vivo mitochondrial capacity and maternal in vitro mitochondrial capacity (by oxygen consumption rate) [ Time Frame: About 15 weeks ]
    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


Biospecimen Retention:   Samples With DNA
Placental biospecimens (placenta, umbilical cord, cord blood). Leg muscle tissue.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy women that are classified as either physically active or sedentary in early pregnancy.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03489564


Locations
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United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Investigators
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Principal Investigator: Leanne M Redman, PhD Pennington Biomedical Research Center

Additional Information:
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Responsible Party: Leanne Redman, Associate Professor, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT03489564     History of Changes
Other Study ID Numbers: PBRC 2017-065
First Posted: April 5, 2018    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Leanne Redman, Pennington Biomedical Research Center:
Pregnancy
Mitochondrial metabolism
Placenta