Postpartum hemorrhage (PPH) due to uterine atony is a major cause of maternal morbidity and mortality. Uterotonic drugs are used to improve the muscle tone of the uterus after birth, and these are effective at reducing the incidence of PPH. Oxytocin is the most commonly used uterotonic drug to prevent and treat PPH. Large doses of this drug are asociated with adverse effects like low blood pressure, nausea, vomiting, abnormal heart rhythms and changes on ECG. Various international bodies recommend varying and high doses of oxytocin in elective cesarean sections. A study performed at Mount Sinai Hospital showed that a much smaller dose of oxytocin is required (ED95 being 0.35IU). However, most of the women included in this study were below a body mass index (BMI) of 40kg/m2.
The investigators seek to find the best dose for patients with a BMI>40kg/m2, as a higher dose may be needed in this population to contract the uterus adequately.
Condition or disease | Intervention/treatment | Phase |
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Postpartum Hemorrhage Obesity | Drug: Oxytocin | Not Applicable |
Postpartum hemorrhage (PPH) is one of the leading causes of death during childbirth and accounts for an estimated 140,000 deaths per year worldwide. The World Health Organization (WHO) recommends active management of the third stage of labor to prevent PPH, even in low risk patients. Prophylactic uterotonic drugs administered after delivery are the main element of active management of the third stage and have been demonstrated to reduce the incidence of PPH by up to 40%. Oxytocin is the most commonly used uterotonic in North America, however it has a very short duration of action and requires a continuous infusion to achieve sustained effect, with large doses associated with adverse effects like low blood pressure, nausea, vomiting, abnormal heart rhythms and changes on ECG.
The prevalence of obesity is increasing in young women and some studies have shown that obese women have higher rates of caesarean delivery compared to non-obese women. Other studies have demonstrated an increased risk of hemorrhage due to poor uterine tone in obese women. Laboratory studies show that BMI alone appears to contribute to blunted uterine muscle responses and therefore contraction responses to oxytocin in obese women.
Previous dose finding studies have excluded those women with a BMI of ≥40kgm2. Therefore, the investigators wish to perform a double-blind dose finding study using the biased coin up-and-down sequential allocation technique to determine the ED90 of oxytocin at cesarean section in those women with a BMI>40.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Biased coin up-and-down design. |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Oxytocin at Elective Cesarean Deliveries: A Dose-finding Study in Women With BMI ≥ 40kg/m2 |
Actual Study Start Date : | June 26, 2019 |
Actual Primary Completion Date : | February 3, 2020 |
Actual Study Completion Date : | February 4, 2020 |
Arm | Intervention/treatment |
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Active Comparator: Oxytocin 0.5IU
Patient is given 0.5IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.
|
Drug: Oxytocin
Oxytocin administered intravenously, over 1 minute following delivery of the fetal head
Other Name: pitocin
|
Active Comparator: Oxytocin 1IU
Patient is given 1IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.
|
Drug: Oxytocin
Oxytocin administered intravenously, over 1 minute following delivery of the fetal head
Other Name: pitocin
|
Active Comparator: Oxytocin 2IU
Patient is given 2IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.
|
Drug: Oxytocin
Oxytocin administered intravenously, over 1 minute following delivery of the fetal head
Other Name: pitocin
|
Active Comparator: Oxytocin 3IU
Patient is given 3IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.
|
Drug: Oxytocin
Oxytocin administered intravenously, over 1 minute following delivery of the fetal head
Other Name: pitocin
|
Active Comparator: Oxytocin 4IU
Patient is given 4IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.
|
Drug: Oxytocin
Oxytocin administered intravenously, over 1 minute following delivery of the fetal head
Other Name: pitocin
|
Active Comparator: Oxytocin 5IU
Patient is given 5IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.
|
Drug: Oxytocin
Oxytocin administered intravenously, over 1 minute following delivery of the fetal head
Other Name: pitocin
|
Blood loss will be calculated through the difference in hematocrit values assessed prior to and at the end of 48 hours after the cesarean delivery, according to the following formula:
Calculated blood loss = EBV ((Pre-op Htc-Post-op Htc)/pre-op Htc). EBV (estimated blood volume) in ml: patient's weight in kg x 85
Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
Mount Sinai Hospital | |
Toronto, Ontario, Canada, M5G1X5 |
Principal Investigator: | Jose Carvalho, MD | MOUNT SINAI HOSPITAL |
Tracking Information | |||||
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First Submitted Date ICMJE | May 17, 2019 | ||||
First Posted Date ICMJE | May 21, 2019 | ||||
Last Update Posted Date | February 6, 2020 | ||||
Actual Study Start Date ICMJE | June 26, 2019 | ||||
Actual Primary Completion Date | February 3, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Uterine tone 2 minutes: questionnaire [ Time Frame: 2 minutes ] Uterine tone, defined as satisfactory or unsatisfactory by the obstetrician at 2 minutes after completion of the oxytocin injection.
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Original Primary Outcome Measures ICMJE |
Uterine tone 2 minutes [ Time Frame: 2 minutes ] Uterine tone, defined as satisfactory or unsatisfactory by the obstetrician at 2 minutes after completion of the oxytocin injection.
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Oxytocin at Elective Cesarean Deliveries: A Dose-finding Study in Women With BMI ≥ 40kg/m2 | ||||
Official Title ICMJE | Oxytocin at Elective Cesarean Deliveries: A Dose-finding Study in Women With BMI ≥ 40kg/m2 | ||||
Brief Summary |
Postpartum hemorrhage (PPH) due to uterine atony is a major cause of maternal morbidity and mortality. Uterotonic drugs are used to improve the muscle tone of the uterus after birth, and these are effective at reducing the incidence of PPH. Oxytocin is the most commonly used uterotonic drug to prevent and treat PPH. Large doses of this drug are asociated with adverse effects like low blood pressure, nausea, vomiting, abnormal heart rhythms and changes on ECG. Various international bodies recommend varying and high doses of oxytocin in elective cesarean sections. A study performed at Mount Sinai Hospital showed that a much smaller dose of oxytocin is required (ED95 being 0.35IU). However, most of the women included in this study were below a body mass index (BMI) of 40kg/m2. The investigators seek to find the best dose for patients with a BMI>40kg/m2, as a higher dose may be needed in this population to contract the uterus adequately. |
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Detailed Description |
Postpartum hemorrhage (PPH) is one of the leading causes of death during childbirth and accounts for an estimated 140,000 deaths per year worldwide. The World Health Organization (WHO) recommends active management of the third stage of labor to prevent PPH, even in low risk patients. Prophylactic uterotonic drugs administered after delivery are the main element of active management of the third stage and have been demonstrated to reduce the incidence of PPH by up to 40%. Oxytocin is the most commonly used uterotonic in North America, however it has a very short duration of action and requires a continuous infusion to achieve sustained effect, with large doses associated with adverse effects like low blood pressure, nausea, vomiting, abnormal heart rhythms and changes on ECG. The prevalence of obesity is increasing in young women and some studies have shown that obese women have higher rates of caesarean delivery compared to non-obese women. Other studies have demonstrated an increased risk of hemorrhage due to poor uterine tone in obese women. Laboratory studies show that BMI alone appears to contribute to blunted uterine muscle responses and therefore contraction responses to oxytocin in obese women. Previous dose finding studies have excluded those women with a BMI of ≥40kgm2. Therefore, the investigators wish to perform a double-blind dose finding study using the biased coin up-and-down sequential allocation technique to determine the ED90 of oxytocin at cesarean section in those women with a BMI>40. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Biased coin up-and-down design. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: Oxytocin
Oxytocin administered intravenously, over 1 minute following delivery of the fetal head
Other Name: pitocin
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
30 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | February 4, 2020 | ||||
Actual Primary Completion Date | February 3, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 50 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Canada | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03957083 | ||||
Other Study ID Numbers ICMJE | 19-02 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Samuel Lunenfeld Research Institute, Mount Sinai Hospital | ||||
Study Sponsor ICMJE | Samuel Lunenfeld Research Institute, Mount Sinai Hospital | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Samuel Lunenfeld Research Institute, Mount Sinai Hospital | ||||
Verification Date | February 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |