A study of the effects of oxytocin and carbetocin on the heart

Phase 1

Conditions: Pregnancy
MedDRA version: 17.0Level: SOCClassification code 10036585Term: Pregnancy, puerperium and perinatal conditionsSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions
MedDRA version: 17.0Level: LLTClassification code 10048862Term: Cesarean sectionSystem Organ Class: 100000004865
Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

Registration Number: EUCTR2014-000507-27-NO

Lead Sponsor: Oslo University Hospital, Division of Emergencies and Critical Care

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

Planned cesarean delivery of single baby
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 400
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Cardiac diseases, intolerance to IMPs, placental diseases.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Cardiac biomarkers may increase after injection of oxytocin. Carbetocin, a new synthetic oxytocin receptor agonist, may have similar effects. This study compares the two drugs in clinical use for treatment and prophylaxis of atonic uterine bleeding;Secondary Objective: Group differences in blood loss and side effects between the two drugs ;Primary end point(s): Troponin I.<br> ;Timepoint(s) of evaluation of this end point: 0, 4, 12, 24, and 48 h

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Troponin T, proBNP, CK, CK-MB, Sodium, and Potassium. Adverse events. Pain.;Timepoint(s) of evaluation of this end point: 0, 4, 12, 24, and 48 h