Respiratory Insufficiency Syndrome of NewbornNCT03693885
Oxytocin Administration Prior Planned Caesarean Section
A study testing Oxytocin challenge test (OCT) in people with Respiratory Insufficiency Syndrome of Newborn and Breastfeeding Status, run by University of Zurich at 5 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Respiratory Insufficiency Syndrome of Newborn, Breastfeeding Status
- What is being tested?
- Oxytocin challenge test (OCT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,450 participants
- Where
- 5 sitesSwitzerland
- Study dates
- 1 Jan 2019to 1 Jun 2025
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Singleton pregnancy >34 weeks
- primary caesarean section, that is without preceding contractions or rupture of the membranes,
- absence of a contraindication to oxytocin
Who cannot join
- Chromosomal aberration
- malformation,
- IUGR,
- Nonreassuring fetal heart rate pattern,
- Placenta praevia,
- maternal substance abuse,
Show all 13Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Switzerland5 sites, 5 recruiting
- Recruiting
Baden Cantonal Hospital
Baden
Leonhard Schäffer, MD, +41 56 486 35 07, leonhard.Schaeffer@ksb.ch
- Recruiting
University Hospital Basel
Basel
Gwendolin Manegold-Brauer, MD, +41 61 265 90 46, Gwendolin.Manegold-Brauer@usb.ch
Sven Wellmann, Prof, +41 61 704 29 24, sven.wellmann@ukbb.ch
- Recruiting
Saint Gallen Cantonal Hospital
Sankt Gallen
Tina Fischer, MD, +41 71 494 18 66, tina.fischer@kssg.ch
- Recruiting
Winterthur Cantonal Hospital
Winterthur
Leila Sultan-Beyer, MD, +41 52 266 27 61, leila.sultan-beyer@ksw.ch
- Recruiting
University Hospital Zurich, Department of Obstetrics
Zurich, Canton of Zurich, 8091
Tilo Burkhardt, MD, +41 44 255 51 92, tilo.burkhardt@usz.ch
About this study
Official title: 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.
Read more
- 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
- Being tested
- Oxytocin challenge test (OCT)
- Keywords
- caesarean section, Oxytocin challenge test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin challenge test (OCT)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| OCT-group | Experimental | 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. Receives: Other: Oxytocin challenge test (OCT) |
| Control | No intervention | standard procedure before planned caesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of neonatal respiratory morbidity
Percentage of infants to be monitored or admitted to neonatology for respiratory distress syndrome
Measured: in the first 4 hours of life
Secondary outcomes (3)
Umbilical cord blood copeptin levels
copeptin levels in pmol/l
Measured: blood sample within 30 minutes after birth
Postnatal neonatal weight change
Maximum neonatal weight change in percent of birth weight
Measured: postnatal day 1-4
Breastfeeding status
Percentage of children who are not, partially or full breastfed
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start1 Jan 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
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 Respiratory Insufficiency Syndrome of NewbornStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- University of Basel
- Responsible party
- Sponsor
- Investigators
- Tilo Burkhardt, MD, Principal investigator, Dept. of Obstetrics, University Hospital Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03693885
- Sponsor's protocol ID
- Lacarus
- Status last verified
- Oct 2023
- First submitted
- 24 Sep 2018
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33472211
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mild Induced Labour Prior to Planned Caesarean Delivery to Improve Neonatal and Maternal Outcome - a Randomized Trial
- ClinicalTrials.gov ID
- NCT03693885
- Acronym / sponsor ID
- Lacarus
- Keywords
- caesarean section, Oxytocin challenge test
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,450 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- University of Basel
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 3 Oct 2018 (actual)
- 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.
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.
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OCT-group | Experimental | Other: Oxytocin challenge test (OCT)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. |
| Control | No intervention | –standard procedure before planned caesarean section |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Singleton pregnancy >34 weeks
- primary caesarean section, that is without preceding contractions or rupture of the membranes,
- absence of a contraindication to oxytocin
Key exclusion criteria (13 listed)
- Chromosomal aberration
- malformation,
- IUGR,
- Nonreassuring fetal heart rate pattern,
- Placenta praevia,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | OCT-group |
Primary outcome
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
3 secondary outcomes
Umbilical cord blood copeptin levels
Time frame: blood sample within 30 minutes after birth
Postnatal neonatal weight change
Time frame: postnatal day 1-4
Breastfeeding status
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Derived from this study: PubMed 33472211Wellmann 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.
- Individual participant dataSharing planned: No
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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
Dept. of Obstetrics, University Hospital Zurich
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin challenge test (OCT) in people with Respiratory Insufficiency Syndrome of Newborn and Breastfeeding Status, run by University of Zurich at 5 sites 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 3 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tilo Burkhardt, MD (+41 44 255 5192, tilo.burkhardt@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of neonatal respiratory morbidity (time frame: in the first 4 hours of life). 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 NCT03693885, 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 31 Oct 2023.