Prospective randomized study of the circulatory effects of two different drugs to contract uterus after cesarean section

Prospective randomized trial comparing the effects of oxytocin and carbetocin on circulation and vascular tone at cesarean section

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004224-10-SE

Enrollment

100

Registered

2013-10-25

Start date

2013-12-06

Completion date

Unknown

Last updated

2018-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean section of pregnant women

Interventions

Trade Name: Pabal Product Name: carbetocin Pharmaceutical Form: Injection Trade Name: Oxytocin Pilum Pharmaceutical Form: Injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Pregnant healthy women at at least 35 gestational weeks, age 18-40 years, planned for cesarean section, understanding written and spoken Swedish, signed informed concent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Pregnancy <35 w, women not understanding written and spoken Swedish, significant cardiovascular, pulmonary disease, hypertension, preeclampsia, diabetes, abnormal pregnancy, problems interfering with measurements. Difficult surgery expected.

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare maternal circulatory effects of oxytocin and carbetocin;Secondary Objective: Not applicable;Primary end point(s): Maternal ECG ST index changes; blood pressure changes; digital photoplethysmographic variable changes.;Timepoint(s) of evaluation of this end point: 0-60 min	—

Secondary

Measure	Time frame
Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A	—

Countries

Sweden

Contacts

Public ContactPer Olofsson

Region Skåne

per.olofsson@med.lu.se4640332167

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026