Columbia University Irving Medical Center
New York, 10032, United States
NCT Number: NCT05772156
Obstetrical hemorrhage (excessive bleeding related to pregnancy) is a leading cause of maternal morbidity (disease or symptom of disease) and mortality (death) worldwide with a significantly higher frequency and severity following cesarean delivery. Twin gestations (twin pregnancy) are at particularly higher risk for postpartum hemorrhage, yet the management of obstetrical bleeding following twin delivery remains identical to singleton delivery.
The purpose of this study is to understand the effect of prophylactic methylergonovine on blood loss in scheduled twin pregnancy cesarean deliveries. Participants will be randomized (like tossing a coin) to Methylergonovine (investigational drug) or water with salt (saline) (placebo). Methylergonovine or saline will be given as an injection immediately after delivery.
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Notify MeUp to 65 year
Female
Interventional
Phase 4
New York, 10032, United States
Obstetrical hemorrhage is a leading cause of maternal morbidity and mortality worldwide with a significantly higher frequency and severity following cesarean delivery. In 2020, 31.9 percent of pregnant women in the United States underwent cesarean delivery, making it the second most common operation performed. Though multiple complications can occur following cesarean delivery, hemorrhage morbidities are among the most common with significant cardiovascular implications. Twin gestations are at particularly higher risk for postpartum hemorrhage due to impaired myometrial contractility and atony following overdistention; increased maternal blood volume; and increased uterine blood flow compared to singletons, yet the management of obstetrical bleeding following twin delivery remains identical to singleton delivery. Current strategies to address intrapartum hemorrhage have relied on pharmacological and mechanical treatments after intraoperative identification. However, there is extensive work on prophylactic therapies administered intraoperatively to prevent obstetrical hemorrhage. Recent evidence has emerged about the utility of prophylactic Methylergonovine for the prevention of obstetrical hemorrhage. Methylergonovine, a semisynthetic ergot alkaloid, acts primarily on alpha adrenergic receptors of uterine and vascular smooth muscle, increasing uterine tone and promoting vasoconstriction. In a randomized trial of 80 women undergoing intrapartum cesarean delivery found that fewer patients who were allocated to the methylergonovine group received additional uterotonic agents (20% vs 55%, relative risk (RR) 0.4, 95% confidence interval (CI) 0.2-0.6). Participants receiving methylergonovine were more likely to have satisfactory uterine tone (80% vs 41%, RR 1.9, 95% CI 1.5-2.6), lower incidence of postpartum hemorrhage (35% vs 59%, RR 0.6, 95% CI 0.4-0.9), lower mean quantitative blood loss (967 mL vs 1,315 mL; mean difference 348, 95% CI 124-572), and a lower frequency of blood transfusion (5% vs 23%, RR 0.2, 95% CI 0.1-0.6). Investigators concluded that the administration of prophylactic methylergonovine in addition to oxytocin in patients undergoing intrapartum cesarean birth reduces the need for additional uterotonic agents. In a prospective study of 1210 participants found that intraoperative, prophylactic methylergonovine decreased post-operative blood loss with no adverse side effects. Randomized trials of Methylergonovine as prophylaxis to prevent hemorrhage in cesarean delivery have exclude twin gestations. Currently, there remains a paucity of research regarding prophylactic procedures for twin cesarean delivery. There is an opportunity to prophylactically address hemorrhage in high-risk groups. Therefore, the investigators propose a prospective randomized controlled trial which will compare maternal blood loss associated with prophylactic methylergonovine during cesarean delivery among patients with twin.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Methylergonovine 200mcg Intramuscular (IM)
Other names: Methergine
Matching saline placebo
Other names: Saline
Time frame: Baseline and Postoperative Day 1 (Approximately 48 hours)
The change in maternal hemoglobin level as taken from blood samples. The change will be calculated from preoperative day 1 (baseline) to postoperative day 1.
Time frame: Intraoperative (Approximately 24 hours)
Surgical time measured from the time of incision to closure
Time frame: Intraoperative (Approximately 24 hours)
At the end of the surgery, the primary surgeon will estimate the blood loss throughout the case.
Time frame: Intraoperative (Approximately 24 hours)
Quantitative blood loss is calculated by weighing the used towels during the operation. The number is calculated by the circulating nurse in the operating room.
Time frame: Intraoperative (Approximately 24 hours)
The number of participants with postpartum hemorrhage (defined as estimated blood loss >1000 cc)
Time frame: Intraoperative (Approximately 24 hours)
Number of participants given uterotonics, such as prostaglandins
Time frame: Intraoperative (Approximately 24 hours)
Number of participants given Tranexamic acid
Time frame: Intraoperative (Approximately 24 hours)
Number of participants requiring the use of any amount of open-label methylergonovine (not blinded study drug)
Time frame: Intraoperative (Approximately 24 hours)
Number of participants requiring transfusion of 1 or more units of packed red blood cells, including whole blood or cell saver.
Time frame: Intraoperative (Approximately 24 hours)
Composite number of surgical or radiological interventions (such as: laparotomy, evacuation of hematoma, hysterectomy, uterine packing, intrauterine balloon tamponade, interventional radiology) to control bleeding and related complications or maternal death.
Time frame: 6 weeks
Number of participants with transfusion related acute lung injury (TRALI)
Time frame: 6 weeks
Number of participants requiring transfusion of 1 or more units of fresh frozen plasma, cryoprecipitate, or platelets or administration of any factor concentrates.
Time frame: 48 hours
Number of participants with acute elevation of serum creatinine of ≥ 0.3 mg/dL
Time frame: 6 weeks
Number of Postpartum infectious complications such as: endometritis, surgical site infection, pelvic abscess
Time frame: 6 weeks
Number of participants with admission to the intensive care unit for more than 24 hours
Time frame: Up to 6 weeks
Length of stay measured from the time of hospital admission to hospital discharge.
Time frame: 6 weeks
The number of participants who experienced hospital re-admission
Time frame: 1 and 5 minutes post-delivery (approximately 24 hours post-baseline)
Apgar score is a measure of the physical condition of a newborn infant. Scores range from 0-10 with a higher score indicating a better outcome; Apgar score of 0-3 is low, 4-6 is moderately abnormal, and 7-10 is reassuring.
Time frame: Time of delivery (Approximately 24 hours)
Number of newborns admitted to the neonatal intensive care unit (NICU).
Columbia University
Other
Prophylactic Methylergonovine in Patients Undergoing Cesarean Delivery With Twin Gestations: A Randomized Controlled Trial
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