Myometrium; ContractilityNCT03505541
Adipokines Effect in Myometrial Contractility
An observational study of Myometrium; Contractility and GDM, run by University of Minnesota at 1 site in United States.
Trial summary
Investigate the effect of two adipokines which are adiponectin and TNFa on the force of myometrial contractility in diabetic, non-obese pregnant women and obese, non-diabetic term pregnant women at the time of scheduled cesarean delivery Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Myometrium; Contractility, GDM, Obesity
- What is being tested?
- Adiponectin and TNFa
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 1 Jul 2019
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant subjects undergoing a scheduled C-section delivery.
Who may be able to join
- Pregnant patients scheduled for a CS at 37-41 weeks of gestation at M Health Birth Place
- Participants age ≥18.
- Full informed consent able to be provided by the participant.
Who cannot join
- Patients undergoing general anesthesia for their CS.
- Pre-gestational DM, and DM diagnosed <24 weeks gestation.
- Patients unable to consent for themselves
- Multiple gestation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Adiponectin and TNFa on Uterine Contractility in GDM and Obese Pregnant Patients
Investigate the effect of two adipokines which are adiponectin and TNFa on the force of myometrial contractility in diabetic, non-obese pregnant women and obese, non-diabetic term pregnant women at the time of scheduled cesarean delivery
- Conditions
- Myometrium; Contractility, GDM, Obesity
- Being tested
- Adiponectin and TNFa
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adiponectin and TNFaBiological
Adiponectin and TNFa are adipokines. Will be added to the myometrial biopsies to investigate their effect on the force of contractility
| Study group | Role | What they receive |
|---|---|---|
| Control group | Healthy, term, non-obese (BMI < 30) pregnant women with a singleton gestation scheduled for CS delivery at 37-41 weeks of gestation. Receives: Biological: Adiponectin and TNFa | |
| Study group 1 | Term pregnant, non-obese (BMI <30), diagnosed with gestational diabetes, scheduled for CS delivery between 37-41 weeks of gestation. Receives: Biological: Adiponectin and TNFa | |
| Study group 2 | Term pregnant, obese (BMI >30), non-diabetic and scheduled for CS delivery between 37-41 weeks of gestation Receives: Biological: Adiponectin and TNFa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on force of contractility
Determine the effect of adiponectin and TNFa on the force of myometrial contractility in diabetic, non-obese pregnant women and obese, non-diabetic term pregnant women at the time of scheduled cesarean delivery
Measured: 24 hours
Secondary outcomes (2)
Force of contractility between study groups
Compare the force of myometrial contractility in study groups compared to control group (non-DM, non-obese term pregnant patients)
Measured: 24 hours
Progesterone effect in control group
Investigate the anti-inflammatory properties of Progesterone (P4) and 17a-Hydroxyprogesterone (HPC) on Adiponectin induced myometrial contractility in control group
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start1 Aug 2018
- Primary completion30 Jun 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myometrium; ContractilityStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine Jacobs, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03505541
- Sponsor's protocol ID
- STUDY00002972
- Status last verified
- Jul 2019
- First submitted
- 12 Apr 2018
- Last updated
- 18 Jul 2019
- Results posted
- 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 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adiponectin and TNFa on Uterine Contractility in GDM and Obese Pregnant Patients
- ClinicalTrials.gov ID
- NCT03505541
- Acronym / sponsor ID
- STUDY00002972
- Conditions
- Myometrium; Contractility, GDM, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 23 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.
Investigate the effect of two adipokines which are adiponectin and TNFa on the force of myometrial contractility in diabetic, non-obese pregnant women and obese, non-diabetic term pregnant women at the time of scheduled cesarean delivery
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Biological: Adiponectin and TNFaHealthy, term, non-obese (BMI < 30) pregnant women with a singleton gestation scheduled for CS delivery at 37-41 weeks of gestation. |
| Study group 1 | – | Biological: Adiponectin and TNFaTerm pregnant, non-obese (BMI <30), diagnosed with gestational diabetes, scheduled for CS delivery between 37-41 weeks of gestation. |
| Study group 2 | – | Biological: Adiponectin and TNFaTerm pregnant, obese (BMI >30), non-diabetic and scheduled for CS delivery between 37-41 weeks of gestation |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant subjects undergoing a scheduled C-section delivery.
Key inclusion criteria (3 listed)
- Pregnant patients scheduled for a CS at 37-41 weeks of gestation at M Health Birth Place
- Participants age ≥18.
- Full informed consent able to be provided by the participant.
Key exclusion criteria (4 listed)
- Patients undergoing general anesthesia for their CS.
- Pre-gestational DM, and DM diagnosed <24 weeks gestation.
- Patients unable to consent for themselves
- Multiple gestation
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 |
|---|---|---|
| Adiponectin and TNFaAdiponectin and TNFa are adipokines. Will be added to the myometrial biopsies to investigate their effect on the force of contractility | Biological | Control group, Study group 1, Study group 2 |
Primary outcome
Effect on force of contractility
Time frame: 24 hours
Determine the effect of adiponectin and TNFa on the force of myometrial contractility in diabetic, non-obese pregnant women and obese, non-diabetic term pregnant women at the time of scheduled cesarean delivery
2 secondary outcomes
Force of contractility between study groups
Time frame: 24 hours
Progesterone effect in control group
Time frame: 24 hours
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 18 Jul 2019.
- Individual participant dataSharing planned: No
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Recruiting
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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.
Katherine Jacobs, MD principal investigator
University of Minnesota
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 Myometrium; Contractility and GDM, run by University of Minnesota 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 3 inclusion and 4 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 18 Jul 2019. 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?
Effect on force of contractility (time frame: 24 hours). 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 18 Jul 2019.