Prospective randomized study of the circulatory effects of two different drugs to contract uterus after cesarean sectio
Phase 1
- Conditions
- Cesarean section of pregnant womenTherapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
- Registration Number
- EUCTR2013-004224-10-SE
- Lead Sponsor
- Region Skåne
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 100
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A