- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03693885
Oxytocin Administration Prior Planned Caesarean Section
Mild Induced Labour Prior to Planned Caesarean Delivery to Improve Neonatal and Maternal Outcome - a Randomized Trial
Spontaneous vaginal delivery of a healthy infant provokes a unique surge in stress hormone concentrations (e.g. AVP (arginine vasopressin) /copeptin) incommensurable with child or adult levels measured in any other situation. In contrast, infants delivered by primary caesarean section without preceding labour have low stress hormone concentrations at birth unless other stressors are present, including chorioamnionitis or intrauterine growth restriction. Infants delivered by caesarean section after a trial of labour show copeptin concentrations between these two extremes.
Objectives:1) To reduce neonatal respiratory morbidity and admission to the Neonatal Intensive Care Unit and increase bonding and breastfeeding by triggering uterine contractions prior to planned caesarean delivery.
2) To collect prospectively weight data of infants in the first 6 months of life to validate and expand our online neonatal weight calculator.
Study design: Open label; randomised, placebo controlled trail Intervention: Oxytocin challenge test (OCT): Infusion of oxytocin 5 IU/500 ml Ringer® lactate at a rate of 12 ml/h and doubled every 10 min until three uterine contractions per 10-min interval are induced, at which point it will be stopped.
Primary endpoint:
- Incidence of neonatal respiratory morbidity
Secondary endpoints:
- Umbilical cord blood copeptin levels
- Postnatal neonatal weight change
- Breastfeeding status
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tilo Burkhardt, MD
- Phone Number: +41 44 255 5192
- Email: tilo.burkhardt@usz.ch
Study Contact Backup
- Name: Sven Wellmann, Prof
- Phone Number: +41 61 704 29 24
- Email: sven.wellmann@ukbb.ch
Study Locations
-
-
-
Baden, Switzerland
- Recruiting
- Baden Cantonal Hospital
-
Contact:
- Leonhard Schäffer, MD
- Phone Number: +41 56 486 35 07
- Email: leonhard.Schaeffer@ksb.ch
-
Basel, Switzerland
- Recruiting
- University Hospital Basel
-
Contact:
- Sven Wellmann, Prof
- Phone Number: +41 61 704 29 24
- Email: sven.wellmann@ukbb.ch
-
Contact:
- Gwendolin Manegold-Brauer, MD
- Phone Number: +41 61 265 90 46
- Email: Gwendolin.Manegold-Brauer@usb.ch
-
Saint Gallen, Switzerland
- Recruiting
- Saint Gallen Cantonal Hospital
-
Contact:
- Tina Fischer, MD
- Phone Number: +41 71 494 18 66
- Email: tina.fischer@kssg.ch
-
Winterthur, Switzerland
- Recruiting
- Winterthur Cantonal Hospital
-
Contact:
- Leila Sultan-Beyer, MD
- Phone Number: +41 52 266 27 61
- Email: leila.sultan-beyer@ksw.ch
-
-
ZH
-
Zurich, ZH, Switzerland, 8091
- Recruiting
- University Hospital Zurich, Department of Obstetrics
-
Contact:
- Tilo Burkhardt, MD
- Phone Number: +41 44 255 51 92
- Email: tilo.burkhardt@usz.ch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Singleton pregnancy >34 weeks
- primary caesarean section, that is without preceding contractions or rupture of the membranes,
- absence of a contraindication to oxytocin
Exclusion Criteria:
- Chromosomal aberration
- malformation,
- IUGR,
- Nonreassuring fetal heart rate pattern,
- Placenta praevia,
- maternal substance abuse,
- infections,
- hypertension,
- preeclampsia,
- diabetes type I or II,
- autoimmune disease (antiphospholipid syndrome, lupus erythematosus, etc.),
- renal disease,
- history of more than one previous caesarean section.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: OCT-group
Oxytocin challenge test: Oxytocin 5 IU/500 ml Ringer® lactate will be infused at a rate of 12 ml/h and doubled every 10 min until it induced three uterine contractions per 10-min interval at which point it will stopped.
|
Infusion of oxytocin 5 IU/500 ml Ringer® lactate at a rate of 12 ml/h and doubled every 10 min until three uterine contractions per 10-min interval are induced, at which point it will be stopped.
|
No Intervention: Control
standard procedure before planned caesarean section
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of neonatal respiratory morbidity
Time Frame: in the first 4 hours of life
|
Percentage of infants to be monitored or admitted to neonatology for respiratory distress syndrome
|
in the first 4 hours of life
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Umbilical cord blood copeptin levels
Time Frame: blood sample within 30 minutes after birth
|
copeptin levels in pmol/l
|
blood sample within 30 minutes after birth
|
Postnatal neonatal weight change
Time Frame: postnatal day 1-4
|
Maximum neonatal weight change in percent of birth weight
|
postnatal day 1-4
|
Breastfeeding status
Time Frame: 1 year
|
Percentage of children who are not, partially or full breastfed
|
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Tilo Burkhardt, MD, Dept. of Obstetrics, University Hospital Zurich
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
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
- Lacarus
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Respiratory Insufficiency Syndrome of Newborn
-
Vyaire MedicalNot yet recruitingRespiratory Insufficiency Syndrome of NewbornItaly
-
Karolinska InstitutetCompletedRespiratory Distress Syndrome, Newborn | Infant, Newborn | Respiratory Insufficiency Syndrome of NewbornSweden
-
Canadian Neonatal NetworkCanadian Institutes of Health Research (CIHR); MOUNT SINAI HOSPITALCompletedRespiratory Insufficiency Syndrome of NewbornCanada
-
Tarah T ColaizyCompletedRespiratory Insufficiency | Apnea of Prematurity | Infant Respiratory Distress SyndromeUnited States
-
Medical University of WarsawJagiellonian University; University of Ottawa; Pomeranian Medical University... and other collaboratorsRecruitingRespiratory Failure | TTN | PPHNPoland
-
University of CologneCompletedTransient Tachypnoea of the NewbornGermany
-
Zekai Tahir Burak Women's Health Research and Education...UnknownTransient Tachypnea of NewbornTurkey
-
Children's Hospital of PhiladelphiaChristiana Care Health ServicesTerminatedInfant, Premature, Diseases | Respiratory Insufficiency Syndrome of NewbornUnited States
-
Children's Hospital of PhiladelphiaThrasher Research FundCompletedInfant, Premature, Diseases | Respiratory Insufficiency Syndrome of NewbornUnited States
-
NICHD Neonatal Research NetworkNational Center for Research Resources (NCRR)TerminatedRespiratory Insufficiency | Respiratory Distress Syndrome | Infant, NewbornUnited States
Clinical Trials on Oxytocin challenge test (OCT)
-
Guy's and St Thomas' NHS Foundation TrustKing's College LondonRecruiting
-
Great Ormond Street Hospital for Children NHS Foundation...University College, LondonCompletedNeuromuscular Diseases | Central HypoventilationUnited Kingdom
-
US Department of Veterans AffairsEmory UniversityCompletedType 2 Diabetes Mellitus | Prediabetic StateUnited States
-
King's College LondonCompleted
-
King's College LondonGuy's and St Thomas' NHS Foundation TrustUnknownEgg Allergy | Food Allergy | Food Allergy in Children | Milk Allergy | Food Allergy in Infants | Nut Allergy | Food Allergen SensitisationUnited Kingdom
-
Triemli HospitalCompletedHemodynamics | Patient MonitoringSwitzerland
-
Alexandria UniversityCompleted
-
Université de SherbrookeCanadian Diabetes AssociationCompleted
-
QOL Medical, LLCCompletedCongenital Sucrase-Isomaltase DeficiencyUnited States