Haemodynamic and Cardiovascular Effects of Carbetocin and Oxytocin
NCT ID: NCT01719952
Last Updated: 2015-02-27
Study Results
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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COMPLETED
NA
50 participants
INTERVENTIONAL
2012-01-31
2014-01-31
Brief Summary
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The aim of the study is to compare the haemodynamic and cardiovascular effects between intravenous carbetocin 100 μg and intravenous oxytocin 5 IU in women undergoing elective Lower Segment Caesarean Section (EL LSCS).
Study hypothesis: A single injection of carbetocin is haemodynamically and cardiovascularly safe and has similar efficacy in comparison to a single injection of oxytocin.
Detailed Description
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The presence of myocardial ischemia symptoms and side effects of both drugs, ECG changes such as ST depression and changes in T-waves.
Hemoglobin and troponin-T level
The need for additional oxytocin infusion and estimated blood loss
The time interval between initial drug administration, type of additional oxytocic intervention that used and complication that happened.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Carbetocin
Carbetocin 100 µg, given as an intravenous bolus over 30 seconds others names are: duratocin, pabal
Carbetocin
IV carbetocin 100mcg, only in selected patient given as an intravenous bolus over 30 seconds by the anaesthetist following clamping of the umbilical cord only in patient that has been randomized to this group.
pitocin 5 IU also given as an intravenous bolus over 30 seconds by the anaesthetist following clamping of the umbilical cord only in patient that has been randomized to this group.
Oxytocin
Other names are Pitocin, syntocinon given as an intravenous bolus over 30 seconds by the anaesthetist following clamping of the umbilical cord only in patient that has been randomized to this group.
Oxytocin
5 IU given as an intravenous bolus over 30 seconds by the anaesthetist following clamping of the umbilical cord only in patient that has been randomized to this group.
Interventions
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Carbetocin
IV carbetocin 100mcg, only in selected patient given as an intravenous bolus over 30 seconds by the anaesthetist following clamping of the umbilical cord only in patient that has been randomized to this group.
pitocin 5 IU also given as an intravenous bolus over 30 seconds by the anaesthetist following clamping of the umbilical cord only in patient that has been randomized to this group.
Oxytocin
5 IU given as an intravenous bolus over 30 seconds by the anaesthetist following clamping of the umbilical cord only in patient that has been randomized to this group.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Low risk for post-partum hemorrhage, such as no proven abruptio placentae, placenta previa, multiple pregnancy, pre-eclampsia / gestational hypertension, previous PPH, obesity (based on BMI pre pregnancy which is ≥ 30 kg/m2), big baby.
3. Ability to provide informed consent.
Exclusion Criteria
2. Preterm Labour
3. Grandmultipara
4. Multiple Pregnancy
5. Placenta Previa
6. Previous PPH
7. Maternal Obesity ( BMI pre pregnancy ≥ 30 kg/m2))
8. Have co-morbidity illness such as hypertension/pre-eclampsia, established cardiac diseases, history or evidence of liver, renal, vascular, or endocrine disease and bleeding disorder.
9. Contraindication to carbetocin and oxytocin
10. Language Barrier
11. Women undergoing general anaesthesia
12. Women who has abnormal baseline ECG that suggestive myocardial ischemia
18 Years
50 Years
FEMALE
No
Sponsors
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Universiti Kebangsaan Malaysia Medical Centre
OTHER
Responsible Party
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Nirmala Chandralega Kampan
MRCOG(UK)
Principal Investigators
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Nirmala C Kampan, MRCOG(UK)
Role: PRINCIPAL_INVESTIGATOR
Universiti Kebangsaan Malaysia Medical Centre
Locations
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Department of O&G
Cheras, Kuala Lumpur, Malaysia
Countries
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Other Identifiers
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UKMMC
Identifier Type: -
Identifier Source: org_study_id