An interventional study of Oxytocin in Postpartum Hemorrhage and Twin, sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital. Completed at 1 site in Canada. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-28.
Sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Not applicable, Interventional, and Treatment
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.
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.
445 studies on the registry are indexed under Postpartum Hemorrhage; 75 are open to participants now.
This study's enrollment of 30 is below the median of 148 across 340 interventional studies indexed under Postpartum Hemorrhage.
Browse Postpartum Hemorrhage studies →Samuel Lunenfeld Research Institute, Mount Sinai Hospital is the lead sponsor of 135 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patient is given 0.5IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.
Drug: Oxytocin
Patient is given 1IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.
Drug: Oxytocin
Patient is given 2IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.
Drug: Oxytocin
Patient is given 3IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.
Drug: Oxytocin
Patient is given 4IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.
Drug: Oxytocin
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
Also known as: pitocin
Uterine tone 2 minutes: questionnaire
Uterine tone, defined as satisfactory or unsatisfactory by the obstetrician at 2 minutes after completion of the oxytocin injection (3 minutes post delivery).
Time frame: 3 minutes
Need for uterine massage: questionnaire
The obstetricians will be asked if there was any need for uterine massage beyond the initial 3 minute evaluation period following delivery.
Time frame: 20 minutes
Intraoperative requirement for additional uterotonic medication
A request made by the obstetrician performing the cesarean delivery for additional uterotonic medication, due to bleeding or poor uterine tone.
Time frame: 2 hours
Calculated estimate of blood loss
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
Time frame: 24 hours
Intravenous fluid administered during surgery
The total volume (ml) of fluid administered from entering the operating room to skin closure.
Time frame: 2 hours
Hypotension: systolic blood pressure less than 80% of baseline
Systolic blood pressure \< 80% of baseline, from drug administration until end of surgery
Time frame: 2 hours
Tachycardia: heart rate greater than 130% of baseline
Heart rate \> 130% of baseline, from drug administration until end of surgery
Time frame: 2 hours
Bradycardia: heart rate less than 70% of baseline
Heart rate \< 70% of baseline or a heart rate \< 50bpm, from drug administration until end of surgery
Time frame: 2 hours
Presence of ventricular tachycardia: ECG
Presence of ventricular tachycardia as recorded by ECG, from drug administration until end of surgery
Time frame: 2 hours
Presence of atrial fibrillation: ECG
Presence of atrial fibrillation as recorded by ECG, from drug administration until end of surgery
Time frame: 2 hours
Presence of atrial flutter: ECG
Presence of atrial flutter as recorded by ECG, from drug administration until end of surgery
Time frame: 2 hours
Presence of nausea: questionnaire
The presence of nausea and number of episodes, from drug administration until end of surgery, as reported by the patient
Time frame: 2 hours
Presence of vomiting: questionnaire
The presence of vomiting and number of episodes, from drug administration until end of surgery
Time frame: 2 hours
Presence of chest pain: questionnaire
Any presence of chest pain, from drug administration until end of surgery, as reported by the patient
Time frame: 2 hours
Presence of shortness of breath: questionnaire
Any presence of shortness of breath, from drug administration until end of surgery, as reported by the patient
Time frame: 2 hours
Presence of headache: questionnaire
Any presence of headache, from drug administration until end of surgery, as reported by the patient
Time frame: 2 hours
Presence of flushing: questionnaire
Any presence of flushing, from drug administration until end of surgery
Time frame: 2 hours
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Samuel Lunenfeld Research Institute, Mount Sinai Hospital