Pregnancy ComplicationsNCT02381106
The ADRB3 Receptor in Pregnancy
An observational study of Pregnancy Complications, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The primary overall objective of this study is to characterize the levels of and compare levels of the ADRB3 receptor in human non-pregnant myometrium, pregnant myometrium at different time points in pregnancy, in normal and dysfunctional labor and also to measure levels and expression of these receptors in placental… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pregnancy Complications
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2014to Dec 2029
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregant women undergoing cesarian section.
Who may be able to join
- Women undergoing cesarian section
Who cannot join
- Interkurrent diseases
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dept of Obstetrics and Gynecology, Danderyd Hospital
Stockholm, 18288
About this study
Official title: The ADRB3 Adrenergic Receptor - a Possible New Target for Controlling Pre-eclampsia and Hypertension in Pregnancy and Uterine Contractions in Non-pregnant and Pregnant Myometrium
The primary overall objective of this study is to characterize the levels of and compare levels of the ADRB3 receptor in human non-pregnant myometrium, pregnant myometrium at different time points in pregnancy, in normal and dysfunctional labor and also to measure levels and expression of these receptors in placental arteries at different maturation statuses of placenta and in pre-eclampsia/hypertension
- Conditions
- Pregnancy Complications
- Keywords
- arterial contractility, Uterine contractility
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women with preeclampsia | Women delivered by cesarian section and with preeclampsia | |
| Women with dysfunctional labor | Women delivered with cesarian section due to dtsfunctional labor | |
| Women with cesarian section due to maternal request | Women with cesarian section due to maternal request | |
| Women with preamture labor | Women with pemature labor undergoing cesarian section |
What is being measured
The primary outcome is the main question the study is designed to answer.
characterization of the levels of the ADRB3 receptor in human pregnant myometrium
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startNov 2014
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Why it stopped: assay difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helena Kopp Kallner, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02381106
- Sponsor's protocol ID
- VAI
- Status last verified
- May 2023
- First submitted
- 11 Nov 2014
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ADRB3 Adrenergic Receptor - a Possible New Target for Controlling Pre-eclampsia and Hypertension in Pregnancy and Uterine Contractions in Non-pregnant and Pregnant Myometrium
- ClinicalTrials.gov ID
- NCT02381106
- Acronym / sponsor ID
- VAI
- Conditions
- Pregnancy Complications
- Keywords
- arterial contractility, Uterine contractility
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: assay difficulties
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 6 Mar 2015 (estimated)
- 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.
The primary overall objective of this study is to characterize the levels of and compare levels of the ADRB3 receptor in human non-pregnant myometrium, pregnant myometrium at different time points in pregnancy, in normal and dysfunctional labor and also to measure levels and expression of these receptors in placental arteries at different maturation statuses of placenta and in pre-eclampsia/hypertension
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Women with preeclampsia | – | –Women delivered by cesarian section and with preeclampsia |
| Women with dysfunctional labor | – | –Women delivered with cesarian section due to dtsfunctional labor |
| Women with cesarian section due to maternal request | – | –Women with cesarian section due to maternal request |
| Women with preamture labor | – | –Women with pemature labor undergoing cesarian section |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregant women undergoing cesarian section.
Key inclusion criteria (1 listed)
- Women undergoing cesarian section
Key exclusion criteria (1 listed)
- Interkurrent diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
characterization of the levels of the ADRB3 receptor in human pregnant myometrium
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Complications, run by Karolinska Institutet at 1 site in Sweden.
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 1 inclusion and 1 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: paused, as of the sponsor's last update on 17 May 2023. 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 Sweden. 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?
Results are not available in the source record.
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?
characterization of the levels of the ADRB3 receptor in human pregnant myometrium (time frame: 1 month). 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 17 May 2023.