ClinicalTrials.gg
CompletedNCT03489564Mito MomsUpdated Sep 27, 2022

Mitochondrial Capacity in Pregnant Women

An observational study in Pregnancy Related and Physical Activity, sponsored by Pennington Biomedical Research Center. Completed at 1 site in United States. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-27.

Sponsored by Pennington Biomedical Research Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 40 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 39 studies in Motor Activity by Pennington Biomedical Research Center — 2 open to participants now, 3 under way, none of them phase 3. Motor Activity · Pennington Biomedical Research Center.

Enrollment
11th of 12
20 · median 57
Started
2018
with 4 others
Observational
12 of 39
1 open now
Registered
29th of 39
by date

Among the 39 studies in Motor Activity by Pennington Biomedical Research Center, this one is the 11th largest by enrollment of the 12 observational ones that give a count, is one of 5 that started in 2018, is one of 12 observational ones, and was the 29th registered.

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

Browse Motor Activity studies →

Open to participants now

2 of the 39 studies in Motor Activity by Pennington Biomedical Research Center are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

Where they have run

Who these studies take

Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.

This study: 18 Years to 40 Years · female · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 39 studies in Motor Activity by Pennington Biomedical Research Center, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Pregnancy Related
  • Physical Activity

Browse trials for

Keywords

  • Pregnancy
  • Mitochondrial metabolism
  • Placenta
04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Pregnant female
  • 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

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
  • or AIDS (self-reported)
  • Individuals with to magnetic resonance spectroscopy such as having magnetic metallic objects in their body
  • Unwillingness for placental biospecimens to be collected at delivery
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Active

    Physically active will be defined by self-report and confirmed by step counts \>8,000 per day from activity monitoring.

    Behavioral: Active

  • Sedentary

    Sedentary lifestyle will be defined by self-report and confirmed by step counts \<5,000 per day from activity monitoring.

    Behavioral: Sedentary

Interventions

  • BehavioralActive

    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.

  • BehavioralSedentary

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 day

Secondary outcomes

  1. 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

    Time frame: About 20 weeks

  2. 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

    Time frame: About 15 weeks

07

Study locations

1 site
  • Pennington Biomedical Research Center
    Baton Rouge, Louisiana 70808, United States
08

References and documents

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2018 to primary completion in Feb 2020, 22 months.

Of 490 non-industry observational studies under Motor Activity, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 48. This study's 22 months is close to that.

Counting every sponsor, half of 500 studies reached it within 22 months; a quarter within 8 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 29, 2018
First posted
Apr 5, 2018
StartActual
Mar 19, 2018
Primary completionActual
Feb 11, 2020
CompletionActual
Feb 11, 2020
Last update
Sep 27, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03489564
Responsible party
Leanne Redman (Associate Professor, Pennington Biomedical Research Center) — Principal investigator
First posted
Apr 5, 2018
Start date
Mar 19, 2018
Primary completion
Feb 11, 2020
Completion
Feb 11, 2020
Last update
Sep 27, 2022

Study contacts

Leanne M Redman, PhD
principal investigator · Pennington Biomedical Research Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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