Effects of Oxytocin and Carbetocin on Renal System in Cesarean Sections

NCT ID: NCT03939806

Last Updated: 2019-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-31

Study Completion Date

2019-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Postpartum Hemorrhage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Oxytocin

Intervention Type DRUG

To be given to Oxytocin group following the clamping of the umbilical cord

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.

Carbetocin

Intervention Type DRUG

To be given to Carbetocin group following the clamping of the umbilical cord

Interventions

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Oxytocin

To be given to Oxytocin group following the clamping of the umbilical cord

Intervention Type DRUG

Carbetocin

To be given to Carbetocin group following the clamping of the umbilical cord

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Term (\>37 weeks of gestation) uncomplicated pregnant women undergoing elective cesarean section

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ufuk University

OTHER

Sponsor Role lead

Responsible Party

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Gamze Sinem Caglar

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ufuk University Faculty of Medicine Hospital

Ankara, Balgat, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Gamze S Çağlar, Prof.Dr.

Role: CONTACT

+903122044000

Baturay K Kazbek, MD

Role: CONTACT

+903122044000

Facility Contacts

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Baturay K Kazbek, MD

Role: primary

+903122044000

References

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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.

Reference Type BACKGROUND
PMID: 23741542 (View on PubMed)

Engstrom 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.

Reference Type BACKGROUND
PMID: 9760035 (View on PubMed)

Other Identifiers

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CO2019

Identifier Type: -

Identifier Source: org_study_id

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