NCT04093479

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2019

Completed
13 days until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

2 months

First QC Date

September 14, 2019

Last Update Submit

February 19, 2021

Conditions

Keywords

laborobesityoxytocin

Outcome Measures

Primary Outcomes (2)

  • maternal BMI, were weight and height will be combined to report BMI in kg/m^2

    mass spectrometry

    eight hours

  • level of oxytocin in plasma during oxytocin infusion

    mass spectrometry

    eight hours

Study Arms (1)

BMI, oxytocin

Repeteadly blood samples will be taken

Other: blood samples

Interventions

blood samples will be taken repeatedly

BMI, oxytocin

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Not participating in other studies at the delivery ward

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics

Linköping, 58185, Sweden

Location

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

bloodplasma

MeSH Terms

Conditions

Obesity

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Marie Blomberg, PhD

    Linkoeping University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 14, 2019

First Posted

September 18, 2019

Study Start

October 1, 2019

Primary Completion

December 1, 2019

Study Completion

August 1, 2020

Last Updated

February 21, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

IPD will not be shared with other researchers

Locations