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OpenTrials
Completed

NCT Number: NCT01962701

Fetal Copeptin After Oxytocin Challenge Test

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

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

University Hospital Zurich, Department of Obstetrics

Zurich, Canton of Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Fetal plasma copeptin concentration

    Time frame: 30 min after delivery

    To be determined in arterial umbilical cord blood at birth

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Acronym: CopOCT

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 14, 2013
Registry last updated
May 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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