Fetal Copeptin After Oxytocin Challenge Test

Pregnancy Clinical Trial

— CopOCT  

Official title:

Fetal Copeptin After Oxytocin Challenge Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01962701
• Other study ID #: CopOCT
• Status: Completed
• Phase: N/A
• First received: October 10, 2013
• Last updated: May 9, 2016
• Start date: January 2013
• Est. completion date: June 2014

Study information

• Verified date: May 2016
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical Trial Summary

The relationship of uterine contractions on fetal copeptin levels in umbilical cord blood is studied.

Description:

Background: Vaginal delivery evokes a dramatic surge in stress hormones facilitating the transition of the infant to extra-uterine life. Infants born by elective cesarean section (C-section) are known to have a higher risk for compromised birth adaptation. Labor is vital for vaginal delivery and triggers fetal stress hormone release. Fetal plasma copeptin, a surrogate marker of arginine vasopressin, has been found to be 100 to 1000-fold increased after vaginal delivery as compared to elective C-section. However, the relationship of labor intensity and fetal stress hormone release is largely unknown.

Objective: The purpose of this study is to determine fetal copeptin in newborns delivered by C-section to mothers who had an oxytocin challenge test (OCT) just prior to birth as compared to those without OCT.

Protocol: Pregnant women at term are eligible to participate if no uterine contractions are reported within the last 24 hours and no contractions are recorded in cardiotocogram over 30 minutes. Further inclusion and exclusion criteria see below. After written informed consent, all participants get an infusion line and participants receive OCT or placebo. The OCT is standardized as follows: 5 IE Syntocinon (oxytocin) in 500 mL Ringer, infusion rate begins with 12 ml/h and is increased by steps of additional 12 ml/h until three contractions within ten minutes are recorded. Subsequently, infusion is stopped. The placebo is Ringer infusion without Syntocinon. C-section is done about 1 to 3 hours after OCT or placebo and arterial umbilical cord blood is collected at birth. Maternal and newborn data are recorded within the first few days after birth, including maternal blood loss, neonatal adaptation, and postnatal weight loss.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion criteria:

• Singleton pregnancy

• Gestational age more than 36 weeks

• No contractions reported within the last 24 hours

• No contractions recorded by 30 min cardiotocogram prior to oxytocin challenge test

Exclusion criteria:

• All contraindications for labor, including placenta praevia

• Serious fetal malformations

• Anhydramnios

• Oligohydramnios

• IUGR < 5. percentile

• Presence of any contractions

• Suspicious or pathological fetal heart rate tracing (cardiotocogram)

• Any clinical or biochemical signs of maternal infection

• Breech presentation

• More than 1 C-section in history

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Pregnancy

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Department of Obstetrics	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fetal plasma copeptin concentration	To be determined in arterial umbilical cord blood at birth	30 min after delivery	No