NCT01962701

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 14, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

May 10, 2016

Status Verified

May 1, 2016

Enrollment Period

1.4 years

First QC Date

October 10, 2013

Last Update Submit

May 9, 2016

Conditions

Pregnancy

Keywords

C-section

Outcome Measures

Primary Outcomes (1)

  • Fetal plasma copeptin concentration

    To be determined in arterial umbilical cord blood at birth

    30 min after delivery

Study Arms (2)

OCT-group

OCT prior to C-section

None-OCT-group

No OCT prior to C-section

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Primary care hospital, healthy pregnant women presenting for delivery at term

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Department of Obstetrics

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 27607861DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

EDTA plasma of arterial umbilical cord blood

Study Officials

  • Tilo Burkhardt, MD

    University Hospital Zurich, Department of Obstetrics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2013

First Posted

October 14, 2013

Study Start

January 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

May 10, 2016

Record last verified: 2016-05

Locations

CH(1)