Impact of Maternal BMI on Plasma Levels of Oxytocin During Labor Augmentation

Completed

• Conditions: Labor; Arrested Active Phase; Maternal Obesity During Childbirth
• Interventions: Other: blood samples

• Registration Number: NCT04093479
• Lead Sponsor: Linkoeping University

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.

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 Timeline

• Study First Submitted: 2019-09-14
• Study First Submitted QC: 2019-09-17
• Study First Posted: 2019-09-18
• Study Start: 2019-10-01
• Primary Completion: 2019-12-01
• Study Completion: 2020-08-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-19
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

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.

Exclusion Criteria

Not participating in other studies at the delivery ward

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BMI, oxytocin	blood samples	Repeteadly blood samples will be taken

Primary Outcome Measures

Name	Time	Method
maternal BMI, were weight and height will be combined to report BMI in kg/m^2	eight hours	mass spectrometry
level of oxytocin in plasma during oxytocin infusion	eight hours	mass spectrometry

Trial Locations

Locations (1)

Department of Obstetrics; 🇸🇪 Linköping, Sweden