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

Maternal Obesity During Childbirth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04093479
• Other study ID #: 110930ingo
• Status: Completed
• Start date: October 1, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: February 2021
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 1, 2020
• Est. primary completion date: December 1, 2019
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Labor; Arrested Active Phase
• Maternal Obesity During Childbirth
• Obesity

Intervention

Other:
• blood samples
blood samples will be taken repeatedly

Locations

Country	Name	City	State
Sweden	Department of Obstetrics	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maternal BMI, were weight and height will be combined to report BMI in kg/m^2	mass spectrometry	eight hours
Primary	level of oxytocin in plasma during oxytocin infusion	mass spectrometry	eight hours