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. Large doses of this drug are associated with adverse effects like lower 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 doses of oxytocin is required (ED95 being 0.35IU). Women who had twins were excluded from this study. It is known that women with a twin pregnancy have a higher risk of poor tone and postpartum hemorrhage.
The investigators seek to find the best dose of oxytocin for the patients with a twin pregnancy. A higher dose may be needed to contract the uterus adequately.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Postpartum Hemorrhage Twin | 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. Furthermore, recent evidence has shown that the rate of PPH secondary to uterine atony is increasing.
Multiple pregnancy is a well-recognized risk factor for PPH. Compared with singleton pregnancy, women with a multiple pregnancy have an increased risk of PPH, severe PPH, transfusion, uterine atony, hysterectomy, prolonged hospital stay and death. This is true in both high- and low-income countries. Uterine atony as a cause of PPH is more likely in multiple pregnancy compared with singleton pregnancy.
Prophylactic uterotonic drugs administered after the delivery have been demonstrated to reduce the incidence of PPH by up to 40%. Oxytocin is the most commonly administered uterotonic drug used to prevent PPH in North America but is associated with adverse effects such as hypotension, nausea, vomiting, dysrhythmias, ST segment abnormalities, and severe water intoxication that may lead to pulmonary edema and convulsions.
Previous dose finding studies have excluded women with twin pregnancies. Therefore, the investigators wish to perform a double blinded dose finding study using the biased coin flip up-and-down sequential allocation technique to determine the ED 90 of oxytocin at cesarean section in those women with a twin pregnancy.
Study Type : | Interventional (Clinical Trial) |
Estimated 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 Twin Pregnancy |
Actual Study Start Date : | August 6, 2019 |
Estimated Primary Completion Date : | December 2021 |
Estimated Study Completion Date : | December 2021 |
Arm | Intervention/treatment |
---|---|
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:
Contact: Jose Carvalho, MD | 416-586-4800 ext 2681 | jose.carvalho@sinaihealthsystem.ca | |
Contact: Kristi Downey, MSc | 416-586-4800 ext 2366 | kristi.downey@uhn.ca |
Canada, Ontario | |
Mount Sinai Hospital | Recruiting |
Toronto, Ontario, Canada, M5G1X5 | |
Contact: Jose Carvalho, MD 416-586-4800 ext 2681 jose.carvalho@sinaihealthsystem.ca | |
Sub-Investigator: Emil Peska, MD | |
Sub-Investigator: Mrinalini Balki, MD | |
Sub-Investigator: Cynthia Maxwell, MD | |
Sub-Investigator: Kristi Downey, MSc | |
Sub-Investigator: Xiang Y Ye, MSc |
Principal Investigator: | Jose Carvalho, MD | MOUNT SINAI HOSPITAL |
Tracking Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | July 17, 2019 | ||||||||
First Posted Date ICMJE | July 19, 2019 | ||||||||
Last Update Posted Date | March 1, 2021 | ||||||||
Actual Study Start Date ICMJE | August 6, 2019 | ||||||||
Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Uterine tone 2 minutes: questionnaire [ Time Frame: 3 minutes ] Uterine tone, defined as satisfactory or unsatisfactory by the obstetrician at 2 minutes after completion of the oxytocin injection (3 minutes post delivery).
|
||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
|
||||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
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 Twin Pregnancy | ||||||||
Official Title ICMJE | Oxytocin at Elective Cesarean Deliveries: A Dose-finding Study in Women With Twin Pregnancy | ||||||||
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. Large doses of this drug are associated with adverse effects like lower 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 doses of oxytocin is required (ED95 being 0.35IU). Women who had twins were excluded from this study. It is known that women with a twin pregnancy have a higher risk of poor tone and postpartum hemorrhage. The investigators seek to find the best dose of oxytocin for the patients with a twin pregnancy. A higher dose may be needed to contract the uterus adequately. |
||||||||
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. Furthermore, recent evidence has shown that the rate of PPH secondary to uterine atony is increasing. Multiple pregnancy is a well-recognized risk factor for PPH. Compared with singleton pregnancy, women with a multiple pregnancy have an increased risk of PPH, severe PPH, transfusion, uterine atony, hysterectomy, prolonged hospital stay and death. This is true in both high- and low-income countries. Uterine atony as a cause of PPH is more likely in multiple pregnancy compared with singleton pregnancy. Prophylactic uterotonic drugs administered after the delivery have been demonstrated to reduce the incidence of PPH by up to 40%. Oxytocin is the most commonly administered uterotonic drug used to prevent PPH in North America but is associated with adverse effects such as hypotension, nausea, vomiting, dysrhythmias, ST segment abnormalities, and severe water intoxication that may lead to pulmonary edema and convulsions. Previous dose finding studies have excluded women with twin pregnancies. Therefore, the investigators wish to perform a double blinded dose finding study using the biased coin flip up-and-down sequential allocation technique to determine the ED 90 of oxytocin at cesarean section in those women with a twin pregnancy. |
||||||||
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 |
||||||||
Condition ICMJE |
|
||||||||
Intervention ICMJE | Drug: Oxytocin
Oxytocin administered intravenously, over 1 minute following delivery of the fetal head
Other Name: pitocin
|
||||||||
Study Arms ICMJE |
|
||||||||
Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
30 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | December 2021 | ||||||||
Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||
Sex/Gender ICMJE |
|
||||||||
Ages ICMJE | 18 Years to 50 Years (Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||
Contacts ICMJE |
|
||||||||
Listed Location Countries ICMJE | Canada | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04025658 | ||||||||
Other Study ID Numbers ICMJE | 19-03 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
|
||||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||||
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 |
|
||||||||
PRS Account | Samuel Lunenfeld Research Institute, Mount Sinai Hospital | ||||||||
Verification Date | February 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |