Maternal Obesity During ChildbirthNCT04093479
Impact of Maternal BMI on Plasma Levels of Oxytocin During Labor Augmentation
An observational study of Maternal Obesity During Childbirth and Labor; Arrested Active Phase, run by Linkoeping University at 1 site in Sweden.
Trial summary
The aim of this study is to examine the associations between maternal BMI and levels of oxytocin in maternal plasma during augmentation with oxytocin during first stage of labor in term pregnancy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Maternal Obesity During Childbirth, Labor; Arrested Active Phase
- What is being tested?
- blood samples
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 1 Oct 2019to 1 Aug 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 years and older
- Women only
- Adult, Older adult
Study population: Full-term pregnancy (from gestational week 37+0), singel pregnancy, vertex presentation, knowledge in the Swedish language, 18 years and older, known BMI, need of labor augmentation with oxytocin infusion during opening stage.
Who may be able to join
- Full-term pregnancy (from gestational week 37+0), singel pregnancy, vertex presentation, knowledge in the Swedish language, 18 years and older, known BMI, need of labor augmentation with oxytocin infusion during opening stage.
Who cannot join
- Not participating in other studies at the delivery ward
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to examine the associations between maternal BMI and levels of oxytocin in maternal plasma during augmentation with oxytocin during first stage of labor in term pregnancy.
Read the detailed description
A translational prospective experimental study in the delivery ward in Linköping. The study population will include women in two BMI groups (underweight/normal weight and overweight/obese) during first stage of labor with singleton full term pregnancy and cephalic presentation.The BMI is calculated from weight and height registered at the first antenatal visit around week 8-12. At the delivery ward, if the women are in need of labor augmentation with oxytocin infusion, a peripheral venous catheter will be placed in the contralateral arm from the arm where oxytocin will be administrated. The oxytocin infusion will be prepared to a concentration of 10 mU/ml and will be given according to a standardized protocol or to an infusion level giving maximum of 5 uterine contractions per 10 minutes. Blood samples for measuring plasma levels of oxytocin will be taken prior to start and before every increase in the rate of oxytocin infusion. The blood samples will be collected through the first stage of labor.
- Being tested
- blood samples
- Keywords
- labor, obesity, oxytocin
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplesOther
blood samples will be taken repeatedly
| Study group | Role | What they receive |
|---|---|---|
| BMI, oxytocin | Repeteadly blood samples will be taken Receives: Other: blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
maternal BMI, were weight and height will be combined to report BMI in kg/m^2
mass spectrometry
Measured: eight hours
level of oxytocin in plasma during oxytocin infusion
mass spectrometry
Measured: eight hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start1 Oct 2019
- Primary completion1 Dec 2019
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maternal Obesity During ChildbirthStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Marie Blomberg, Linkoeping University
- Investigators
- Marie Blomberg, PhD, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093479
- Sponsor's protocol ID
- 110930ingo
- Status last verified
- Feb 2021
- First submitted
- 14 Sep 2019
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers
Publications
Ramo Isgren A, Carlhall S, Dennis Retrato M, Kodikara C, A Ubhayasekera K, Kjolhede P, Bergquist J, Blomberg M. The association between maternal body mass index and serial plasma oxytocin levels during labor. PLoS One. 2023 Aug 11;18(8):e0290038. doi: 10.1371/journal.pone.0290038. eCollection 2023.
PubMed 37566578
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Maternal BMI on Plasma Levels of Oxytocin During Labor Augmentation
- ClinicalTrials.gov ID
- NCT04093479
- Acronym / sponsor ID
- 110930ingo
- Keywords
- labor, obesity, oxytocin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 18 Sep 2019 (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.
The aim of this study is to examine the associations between maternal BMI and levels of oxytocin in maternal plasma during augmentation with oxytocin during first stage of labor in term pregnancy.
Detailed description
A translational prospective experimental study in the delivery ward in Linköping. The study population will include women in two BMI groups (underweight/normal weight and overweight/obese) during first stage of labor with singleton full term pregnancy and cephalic presentation.The BMI is calculated from weight and height registered at the first antenatal visit around week 8-12. At the delivery ward, if the women are in need of labor augmentation with oxytocin infusion, a peripheral venous catheter will be placed in the contralateral arm from the arm where oxytocin will be administrated. The oxytocin infusion will be prepared to a concentration of 10 mU/ml and will be given according to a standardized protocol or to an infusion level giving maximum of 5 uterine contractions per 10 minutes. Blood samples for measuring plasma levels of oxytocin will be taken prior to start and before every increase in the rate of oxytocin infusion. The blood samples will be collected through the first stage of labor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BMI, oxytocin | – | Other: blood samplesRepeteadly blood samples will be taken |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Full-term pregnancy (from gestational week 37+0), singel pregnancy, vertex presentation, knowledge in the Swedish language, 18 years and older, known BMI, need of labor augmentation with oxytocin infusion during opening stage.
Key inclusion criteria (1 listed)
- Full-term pregnancy (from gestational week 37+0), singel pregnancy, vertex presentation, knowledge in the Swedish language, 18 years and older, known BMI, need of labor augmentation with oxytocin infusion during opening stage.
Key exclusion criteria (1 listed)
- Not participating in other studies at the delivery ward
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 |
|---|---|---|
| blood samplesblood samples will be taken repeatedly | Other | BMI, oxytocin |
Primary outcome
maternal BMI, were weight and height will be combined to report BMI in kg/m^2
Time frame: eight hours
mass spectrometry
level of oxytocin in plasma during oxytocin infusion
Time frame: eight hours
mass spectrometry
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 21 Feb 2021.
- Derived from this study: PubMed 37566578Ramo Isgren A, Carlhall S, Dennis Retrato M, Kodikara C, A Ubhayasekera K, Kjolhede P, Bergquist J, Blomberg M. The association between maternal body mass index and serial plasma oxytocin levels during labor. PLoS One. 2023 Aug 11;18(8):e0290038. doi: 10.1371/journal.pone.0290038. eCollection 2023.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers
Related trials for Maternal Obesity During Childbirth
Active, not recruiting
An Optimized Programming of Healthy Children (APPROACH)
Pregnancy, Obesity
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.
Marie Blomberg, PhD principal investigator
Linkoeping University
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 Maternal Obesity During Childbirth and Labor; Arrested Active Phase, run by Linkoeping University 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: finished, as of the sponsor's last update on 21 Feb 2021. 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?
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?
maternal BMI, were weight and height will be combined to report BMI in kg/m^2 (time frame: eight hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04093479, which also lists 1 linked publication.
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 21 Feb 2021.