Pregnancy RelatedMito MomsNCT03489564
Mitochondrial Capacity in Pregnant Women
An observational study of Pregnancy Related and Physical Activity, run by Pennington Biomedical Research Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Physical Activity
- What is being tested?
- Active and Sedentary
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2018to 11 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy women that are classified as either physically active or sedentary in early pregnancy.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: The Effect of Physical Activity on in Vivo and in Vitro Mitochondrial Capacity in Pregnant Women
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
- Being tested
- Active, Sedentary
- Keywords
- Pregnancy, Mitochondrial metabolism, Placenta
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActiveBehavioural
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.
SedentaryBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Active | Physically active will be defined by self-report and confirmed by step counts >8,000 per day from activity monitoring. Receives: Behavioral: Active | |
| Sedentary | Sedentary lifestyle will be defined by self-report and confirmed by step counts <5,000 per day from activity monitoring. Receives: Behavioral: Sedentary |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (2)
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
Measured: About 20 weeks
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
Measured: About 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start19 Mar 2018
- Primary completion11 Feb 2020
- Study completion11 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leanne Redman, Pennington Biomedical Research Center
- Investigators
- Leanne M Redman, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489564
- Sponsor's protocol ID
- PBRC 2017-065
- Acronym
- Mito Moms
- Status last verified
- Sep 2022
- First submitted
- 29 Mar 2018
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Physical Activity on in Vivo and in Vitro Mitochondrial Capacity in Pregnant Women
- ClinicalTrials.gov ID
- NCT03489564
- Acronym / sponsor ID
- Mito Moms / PBRC 2017-065
- Conditions
- Pregnancy Related, Physical Activity
- Keywords
- Pregnancy, Mitochondrial metabolism, Placenta
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- 11 Feb 2020 (actual)
- Study completion
- 11 Feb 2020 (actual)
- First posted
- 5 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | – | Behavioral: ActivePhysically active will be defined by self-report and confirmed by step counts >8,000 per day from activity monitoring. |
| Sedentary | – | Behavioral: SedentarySedentary lifestyle will be defined by self-report and confirmed by step counts <5,000 per day from activity monitoring. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy women that are classified as either physically active or sedentary in early pregnancy.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ActiveNo 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. | Behavioural | Active |
| SedentaryNo 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. | Behavioural | Sedentary |
Primary outcome
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
2 secondary outcomes
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 mitochondrial capacity and maternal in vitro mitochondrial capacity (by oxygen consumption rate)
Time frame: About 15 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Pennington Biomedical Research Center website description and webscreener surveyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leanne M Redman, PhD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related and Physical Activity, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant in vitro mitochondrial capacity (by oxygen consumption rate) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2022.