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Oxytocin Administration Prior Planned Caesarean Section

Primary Purpose

Respiratory Insufficiency Syndrome of Newborn, Breastfeeding Status

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Oxytocin challenge test (OCT)
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Insufficiency Syndrome of Newborn focused on measuring caesarean section, Oxytocin challenge test

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital Zurich, Department of Obstetrics
  • Baden Cantonal Hospital
  • University Hospital Basel
  • Saint Gallen Cantonal Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

OCT-group

Control

Arm Description

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.

standard procedure before planned caesarean section

Outcomes

Primary Outcome Measures

Incidence of neonatal respiratory morbidity
Percentage of infants to be monitored or admitted to neonatology for respiratory distress syndrome

Secondary Outcome Measures

Umbilical cord blood copeptin levels
copeptin levels in pmol/l
Postnatal neonatal weight change
Maximum neonatal weight change in percent of birth weight
Breastfeeding status
Percentage of children who are not, partially or full breastfed

Full Information

First Posted
September 24, 2018
Last Updated
October 2, 2018
Sponsor
University of Zurich
Collaborators
University of Basel
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1. Study Identification

Unique Protocol Identification Number
NCT03693885
Brief Title
Oxytocin Administration Prior Planned Caesarean Section
Official Title
Mild Induced Labour Prior to Planned Caesarean Delivery to Improve Neonatal and Maternal Outcome - a Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Anticipated)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
University of Basel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency Syndrome of Newborn, Breastfeeding Status
Keywords
caesarean section, Oxytocin challenge test

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OCT-group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
standard procedure before planned caesarean section
Intervention Type
Other
Intervention Name(s)
Oxytocin challenge test (OCT)
Intervention Description
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 Outcome Measure Information:
Title
Incidence of neonatal respiratory morbidity
Description
Percentage of infants to be monitored or admitted to neonatology for respiratory distress syndrome
Time Frame
in the first 4 hours of life
Secondary Outcome Measure Information:
Title
Umbilical cord blood copeptin levels
Description
copeptin levels in pmol/l
Time Frame
blood sample within 30 minutes after birth
Title
Postnatal neonatal weight change
Description
Maximum neonatal weight change in percent of birth weight
Time Frame
postnatal day 1-4
Title
Breastfeeding status
Description
Percentage of children who are not, partially or full breastfed
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tilo Burkhardt, MD
Phone
+41 44 255 5192
Email
tilo.burkhardt@usz.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Sven Wellmann, Prof
Phone
+41 61 704 29 24
Email
sven.wellmann@ukbb.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tilo Burkhardt, MD
Organizational Affiliation
Dept. of Obstetrics, University Hospital Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Department of Obstetrics
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Baden Cantonal Hospital
City
Baden
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leonhard Schäffer, MD
Phone
+41 56 486 35 07
Email
leonhard.Schaeffer@ksb.ch
Facility Name
University Hospital Basel
City
Basel
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gwendolin Manegold-Brauer, MD
Phone
+41 61 265 90 46
Email
Gwendolin.Manegold-Brauer@usb.ch
First Name & Middle Initial & Last Name & Degree
Sven Wellmann, Prof
Phone
+41 61 704 29 24
Email
sven.wellmann@ukbb.ch
Facility Name
Saint Gallen Cantonal Hospital
City
Saint Gallen
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tina Fischer, MD
Phone
+41 71 494 18 66
Email
tina.fischer@kssg.ch

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33472211
Citation
Wellmann S, Manegold-Brauer G, Fischer T, Schaffer L, Gaertner VD, Malfertheiner SF, Burkhardt T. Improving Neonatal and Maternal Outcome by Inducing Mild Labor before Elective Cesarean Section: The Lacarus Randomized Controlled Trial. Neonatology. 2021;118(1):116-121. doi: 10.1159/000512752. Epub 2021 Jan 20.
Results Reference
derived

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Oxytocin Administration Prior Planned Caesarean Section

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