PregnancyCopOCTNCT01962701
Fetal Copeptin After Oxytocin Challenge Test
An observational study of Pregnancy, run by University of Zurich at 1 site in Switzerland.
Trial summary
The relationship of uterine contractions on fetal copeptin levels in umbilical cord blood is studied. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pregnancy
- How many people
- 140 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2013to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Primary care hospital, healthy pregnant women presenting for delivery at term
Who may be able to join
- 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
Who cannot join
- All contraindications for labor, including placenta praevia
- Serious fetal malformations
- Anhydramnios
- Oligohydramnios
- IUGR < 5. percentile
- Presence of any contractions
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Department of Obstetrics
Zurich, Canton of Zurich, 8091
About this study
The relationship of uterine contractions on fetal copeptin levels in umbilical cord blood is studied.
Read the 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.
- Conditions
- Pregnancy
- Keywords
- C-section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| OCT-group | OCT prior to C-section | |
| None-OCT-group | No OCT prior to C-section |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal plasma copeptin concentration
To be determined in arterial umbilical cord blood at birth
Measured: 30 min after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tilo Burkhardt, MD, Principal investigator, University Hospital Zurich, Department of Obstetrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962701
- Sponsor's protocol ID
- CopOCT
- Acronym
- CopOCT
- Status last verified
- May 2016
- First submitted
- 10 Oct 2013
- Last updated
- 10 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Wellmann S, Koslowski A, Spanaus K, Zimmermann R, Burkhardt T. Fetal Release of Copeptin in Response to Maternal Oxytocin Administration: A Randomized Controlled Trial. Obstet Gynecol. 2016 Oct;128(4):699-703. doi: 10.1097/AOG.0000000000001594.
PubMed 27607861
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Copeptin After Oxytocin Challenge Test
- ClinicalTrials.gov ID
- NCT01962701
- Acronym / sponsor ID
- CopOCT / CopOCT
- Conditions
- Pregnancy
- Keywords
- C-section
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 14 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The relationship of uterine contractions on fetal copeptin levels in umbilical cord blood is studied.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OCT-group | – | –OCT prior to C-section |
| None-OCT-group | – | –No OCT prior to C-section |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Primary care hospital, healthy pregnant women presenting for delivery at term
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- All contraindications for labor, including placenta praevia
- Serious fetal malformations
- Anhydramnios
- Oligohydramnios
- IUGR < 5. percentile
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fetal plasma copeptin concentration
Time frame: 30 min after delivery
To be determined in arterial umbilical cord blood at birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2016.
- Derived from this study: PubMed 27607861Wellmann S, Koslowski A, Spanaus K, Zimmermann R, Burkhardt T. Fetal Release of Copeptin in Response to Maternal Oxytocin Administration: A Randomized Controlled Trial. Obstet Gynecol. 2016 Oct;128(4):699-703. doi: 10.1097/AOG.0000000000001594.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tilo Burkhardt, MD principal investigator
University Hospital Zurich, Department of Obstetrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetal plasma copeptin concentration (time frame: 30 min after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01962701, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2016.