Postpartum HemorrhageNCT03939806
Effects of Oxytocin and Carbetocin on Renal System in Cesarean Sections
An observational study of Postpartum Hemorrhage, run by Ufuk University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the renal outcome of patients undergoing elective C/S where oxytocin or carbetocin is used for postpartum hemorrhage prophylaxis. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Oxytocin and Carbetocin
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2019to Jun 2019
- Phase
- Observational
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of term (gestational age greater than 37 weeks) pregnant women scheduled to undergo elective cesarean section.
Who may be able to join
- Term (>37 weeks of gestation) uncomplicated pregnant women undergoing elective cesarean section
Who cannot join
- Patients refusing to participate in the study
- Complicated pregnancies
- Patients with risk factors for postpartum hemorrhage
- Contraindications for oxytocin or carbetocin usage
- Patients with known renal diseases
- Preterm births (<37 weeks of gestation)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ufuk University Faculty of Medicine Hospital
Ankara, Balgat, 06510
Baturay K Kazbek, MD, +903122044000, bkkazbek@gmail.com
About this study
Official title: Renal Effects of Carbetocin and Oxytocin in Cesarean Section for Preventing Post-partum Haemorrhage: a Prospective Randomized Study
The aim of this study is to evaluate the renal outcome of patients undergoing elective C/S where oxytocin or carbetocin is used for postpartum hemorrhage prophylaxis.
- 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
To be given to Oxytocin group following the clamping of the umbilical cord
CarbetocinDrug
To be given to Carbetocin group following the clamping of the umbilical cord
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | This group will be given 3 IU / 3 ml oxytocin (intravenously) after the clamping of the umbilical cord. Uterine tonus will be assessed after 60 seconds and if it is lower than 7, oxytocin 3 IU / 3 ml will be repeated, up to a maximum of three times. If uterine tonus is still lower than 7, rescue uterotonics such as intramuscular methylergonovine or intravenous misoprostol will be administered. Receives: Drug: Oxytocin | |
| Carbetocin | This group will be given 100 mcg / 3 ml carbetocin (intravenously) after the clamping of the umbilical cord. If uterine tonus is lower than 7, rescue uterotonics such as intramuscular methylergonovine or intravenous misoprostol will be administered. Receives: Drug: Carbetocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine volume
Total amount of intraoperative urine output in milliliters
Measured: Intraoperative period
Urinary sodium
The change in urinary sodium content (milligrams) compared to the preoperative period
Measured: Preoperative, Postoperative 2nd, 4th, 24th hours
Blood sodium
The change in blood sodium content (milligrams) compared to the preoperative period
Measured: Preoperative, Postoperative 2nd, 4th, 24th hours
Secondary outcomes (4)
Blood osmolality
The change in blood osmolality compared to the preoperative period
Measured: Preoperative, Postoperative 2nd, 4th, 24th hours
Blood loss
The total volume of intraoperative blood loss
Measured: Intraoperative period
Need for additional uterotonics
Total dose (milligrams) of additional uterotonics administered
Measured: Starting from the preoperative period, ending at the 24th postoperative hour
Blood transfusion
Total volume (milliliters) of blood transfused
Measured: Starting from the clamping of the umbilical cord, ending at the 24th postoperative hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study startMay 2019 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postpartum HemorrhageStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ufuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Sinem Caglar, Ufuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939806
- Sponsor's protocol ID
- CO2019
- Status last verified
- May 2019
- First submitted
- 3 May 2019
- Last updated
- 13 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Larciprete G, Montagnoli C, Frigo M, Panetta V, Todde C, Zuppani B, Centonze C, Bompiani A, Malandrenis I, Cirese A, Valensise H. Carbetocin versus oxytocin in caesarean section with high risk of post-partum haemorrhage. J Prenat Med. 2013 Jan;7(1):12-8.
PubMed 23741542Engstrom T, Barth T, Melin P, Vilhardt H. Oxytocin receptor binding and uterotonic activity of carbetocin and its metabolites following enzymatic degradation. Eur J Pharmacol. 1998 Aug 21;355(2-3):203-10. doi: 10.1016/s0014-2999(98)00513-5.
PubMed 9760035
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Effects of Carbetocin and Oxytocin in Cesarean Section for Preventing Post-partum Haemorrhage: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT03939806
- Acronym / sponsor ID
- CO2019
- Conditions
- Postpartum Hemorrhage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ufuk UniversityUniversity, hospital or other
- Study start
- May 2019 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 7 May 2019 (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.
The aim of this study is to evaluate the renal outcome of patients undergoing elective C/S where oxytocin or carbetocin is used for postpartum hemorrhage prophylaxis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | – | Drug: OxytocinThis group will be given 3 IU / 3 ml oxytocin (intravenously) after the clamping of the umbilical cord. Uterine tonus will be assessed after 60 seconds and if it is lower than 7, oxytocin 3 IU / 3 ml will be repeated, up to a maximum of three times. If uterine tonus is still lower than 7, rescue uterotonics such as intramuscular methylergonovine or intravenous misoprostol will be administered. |
| Carbetocin | – | Drug: CarbetocinThis group will be given 100 mcg / 3 ml carbetocin (intravenously) after the clamping of the umbilical cord. If uterine tonus is lower than 7, rescue uterotonics such as intramuscular methylergonovine or intravenous misoprostol will be administered. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of term (gestational age greater than 37 weeks) pregnant women scheduled to undergo elective cesarean section.
Key inclusion criteria (1 listed)
- Term (>37 weeks of gestation) uncomplicated pregnant women undergoing elective cesarean section
Key exclusion criteria (6 listed)
- Patients refusing to participate in the study
- Complicated pregnancies
- Patients with risk factors for postpartum hemorrhage
- Contraindications for oxytocin or carbetocin usage
- Patients with known renal diseases
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 |
|---|---|---|
| OxytocinTo be given to Oxytocin group following the clamping of the umbilical cord | Drug | Oxytocin |
| CarbetocinTo be given to Carbetocin group following the clamping of the umbilical cord | Drug | Carbetocin |
Primary outcome
Urine volume
Time frame: Intraoperative period
Total amount of intraoperative urine output in milliliters
Urinary sodium
Time frame: Preoperative, Postoperative 2nd, 4th, 24th hours
The change in urinary sodium content (milligrams) compared to the preoperative period
Blood sodium
Time frame: Preoperative, Postoperative 2nd, 4th, 24th hours
The change in blood sodium content (milligrams) compared to the preoperative period
4 secondary outcomes
Blood osmolality
Time frame: Preoperative, Postoperative 2nd, 4th, 24th hours
Blood loss
Time frame: Intraoperative period
Need for additional uterotonics
Time frame: Starting from the preoperative period, ending at the 24th postoperative hour
Blood transfusion
Time frame: Starting from the clamping of the umbilical cord, ending at the 24th postoperative hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
- Background: PubMed 23741542Larciprete G, Montagnoli C, Frigo M, Panetta V, Todde C, Zuppani B, Centonze C, Bompiani A, Malandrenis I, Cirese A, Valensise H. Carbetocin versus oxytocin in caesarean section with high risk of post-partum haemorrhage. J Prenat Med. 2013 Jan;7(1):12-8.
- Background: PubMed 9760035Engstrom T, Barth T, Melin P, Vilhardt H. Oxytocin receptor binding and uterotonic activity of carbetocin and its metabolites following enzymatic degradation. Eur J Pharmacol. 1998 Aug 21;355(2-3):203-10. doi: 10.1016/s0014-2999(98)00513-5.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Hemorrhage, run by Ufuk University at 1 site in Turkey (Türkiye).
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 1 inclusion and 6 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 13 May 2019. 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 Turkey (Türkiye). 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 Gamze S Çağlar, Prof.Dr. (+903122044000, gamzesinem@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine volume (time frame: Intraoperative period). The study lists 3 primary outcomes in all. 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 NCT03939806, which also lists 2 linked publications.
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 13 May 2019.