- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01962701
Fetal Copeptin After Oxytocin Challenge Test (CopOCT)
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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ZH
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Zurich, ZH, Switzerland, 8091
- University Hospital Zurich, Department of Obstetrics
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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OCT-group
OCT prior to C-section
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None-OCT-group
No OCT prior to C-section
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fetal plasma copeptin concentration
Time Frame: 30 min after delivery
|
To be determined in arterial umbilical cord blood at birth
|
30 min after delivery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tilo Burkhardt, MD, University Hospital Zurich, Department of Obstetrics
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CopOCT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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