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Fetal Copeptin After Oxytocin Challenge Test (CopOCT)

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ClinicalTrials.gov Identifier: NCT01962701
Recruitment Status : Completed
First Posted : October 14, 2013
Last Update Posted : May 10, 2016
Sponsor:
Information provided by (Responsible Party):
University of Zurich

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

Condition or disease
Pregnancy

Detailed 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.

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Study Type : Observational
Actual Enrollment : 140 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Fetal Copeptin After Oxytocin Challenge Test
Study Start Date : January 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Group/Cohort
OCT-group
OCT prior to C-section
None-OCT-group
No OCT prior to C-section



Primary Outcome Measures :
  1. Fetal plasma copeptin concentration [ Time Frame: 30 min after delivery ]
    To be determined in arterial umbilical cord blood at birth


Biospecimen Retention:   Samples Without DNA
EDTA plasma of arterial umbilical cord blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary care hospital, healthy pregnant women presenting for delivery at term
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01962701


Locations
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Switzerland
University Hospital Zurich, Department of Obstetrics
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Tilo Burkhardt, MD University Hospital Zurich, Department of Obstetrics

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01962701    
Other Study ID Numbers: CopOCT
First Posted: October 14, 2013    Key Record Dates
Last Update Posted: May 10, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University of Zurich:
C-section
Additional relevant MeSH terms:
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Diabetes Insipidus
Kidney Diseases
Urologic Diseases
Pituitary Diseases
Endocrine System Diseases
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs