Postpartum HemorrhagePhase 4NCT03651882
Oxytocin i.m./i.v. Versus Carbetocin i.v. in Elective Cesarean Sections
A Phase 4 study testing Oxytocin and Carbetocin in people with Postpartum Hemorrhage, run by University of Zurich at 1 site in Switzerland.
Trial summary
Objective is to proof non-inferiority of intramyometrial and intravenous oxytocin application compared to intravenous carbetocin for prevention of postpartum hemorrhage in planned, uncomplicated cesarean deliveries. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Oxytocin and Carbetocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 1 siteSwitzerland
- Study dates
- 7 Aug 2018to 10 Jan 2022
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- elective cesarean section
- present informed consent
- completed 36 weeks of gestation
Who cannot join
- need for intubation (carbetocin is only licensed for epidural or spinal anesthesia)
- multiple fetus pregnancy
- known coagulopathy
- Placenta praevia
- morbidly adherent placenta
- placental abruption
Show all 10Show fewer
- thrombocyte dysfunction
- HELLP-syndrome
- preeclampsia
- history of uterine atony
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intramyometrial and Intravenous Oxytocin Compared to Intravenous Carbetocin for Prevention of Postpartum Hemorrhage in Elective Cesarean Sections - a Monocentric Randomized Controlled Study
Objective is to proof non-inferiority of intramyometrial and intravenous oxytocin application compared to intravenous carbetocin for prevention of postpartum hemorrhage in planned, uncomplicated cesarean deliveries.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Oxytocin, Carbetocin
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Oxytocin given in a combined regimen: after delivery 10 IE of oxytocin are applied intramyometrially and 10 IE of oxytocin are given over an infusion of 1000ml of 0.9% NaCL over 12 hours intravenously.
CarbetocinDrug
Carbetocin is given 0.1mg intravenously as a bolus after delivery.
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Active comparator | Not described Receives: Drug: Oxytocin |
| Carbetocin | Active comparator | Not described Receives: Drug: Carbetocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of women with a delta hemoglobin ≥ 30g/l.
Delta hemoglobin is defined as the difference of the hemoglobin at admission minus the hemoglobin after delivery, usually 24-48 hours after the delivery.
Measured: 48 hours
Secondary outcomes (8)
adverse maternal outcome parameters
decrease in hemoglobin (delta hemoglobin, in g/l)
Measured: 15 days
adverse maternal outcome parameters
estimated blood loss (in mL),
Measured: 15 days
adverse maternal outcome parameters
incidence of PPH (in %)
Measured: 15 days
adverse maternal outcome parameters
use of additional uterotonic agents (prostaglandines)
Measured: 15 days
adverse maternal outcome parameters
blood transfusion (number of packed red cells)
Measured: 15 days
adverse maternal outcome parameters
length of surgery (in minutes)
Measured: 15-300 minutes
adverse maternal outcome parameters
number of patients with revision (second surgery in the 24hours following the primary cesarean section)
Measured: 15 days
adverse maternal outcome parameters
admission to an intensive care unit (%)
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start7 Aug 2018
- Primary completion10 Jan 2022
- Study completion10 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HemorrhageStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Before c-section the patients will be randomized to the oxytocin or the carbetocin group.
- Masking
- None (open label)
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Haslinger, M.D., Study chair, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03651882
- Sponsor's protocol ID
- BASEC-Nr: 2017-01750
- Status last verified
- May 2023
- First submitted
- 24 Jul 2018
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intramyometrial and Intravenous Oxytocin Compared to Intravenous Carbetocin for Prevention of Postpartum Hemorrhage in Elective Cesarean Sections - a Monocentric Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03651882
- Acronym / sponsor ID
- BASEC-Nr: 2017-01750
- Conditions
- Postpartum Hemorrhage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 29 Aug 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.
Objective is to proof non-inferiority of intramyometrial and intravenous oxytocin application compared to intravenous carbetocin for prevention of postpartum hemorrhage in planned, uncomplicated cesarean deliveries.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Before c-section the patients will be randomized to the oxytocin or the carbetocin group.
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Active comparator | Drug: Oxytocin |
| Carbetocin | Active comparator | Drug: Carbetocin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- elective cesarean section
- present informed consent
- completed 36 weeks of gestation
Key exclusion criteria (10 listed)
- need for intubation (carbetocin is only licensed for epidural or spinal anesthesia)
- multiple fetus pregnancy
- known coagulopathy
- Placenta praevia
- morbidly adherent placenta
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 |
|---|---|---|
| OxytocinOxytocin given in a combined regimen: after delivery 10 IE of oxytocin are applied intramyometrially and 10 IE of oxytocin are given over an infusion of 1000ml of 0.9% NaCL over 12 hours intravenously. | Drug | Oxytocin |
| CarbetocinCarbetocin is given 0.1mg intravenously as a bolus after delivery. | Drug | Carbetocin |
Primary outcome
incidence of women with a delta hemoglobin ≥ 30g/l.
Time frame: 48 hours
Delta hemoglobin is defined as the difference of the hemoglobin at admission minus the hemoglobin after delivery, usually 24-48 hours after the delivery.
8 secondary outcomes
adverse maternal outcome parameters
Time frame: 15 days
adverse maternal outcome parameters
Time frame: 15 days
adverse maternal outcome parameters
Time frame: 15 days
adverse maternal outcome parameters
Time frame: 15 days
adverse maternal outcome parameters
Time frame: 15 days
adverse maternal outcome parameters
Time frame: 15-300 minutes
adverse maternal outcome parameters
Time frame: 15 days
adverse maternal outcome parameters
Time frame: 15 days
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 24 May 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Postpartum Hemorrhage
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Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
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Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
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Prevention of Postpartum Hemorrhage With Tranexamic Acid
Post Partum Hemorrhage
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.
Christian Haslinger, M.D. study chair
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxytocin and Carbetocin in people with Postpartum Hemorrhage, 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 3 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 24 May 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
incidence of women with a delta hemoglobin ≥ 30g/l. (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 May 2023.