A Randomized Controlled Trial to Assess the Effectiveness of Multimodal Prophylactic Uterotonics in Patients Undergoing Non-Elective Cesarean Sections After a Trial of Labor
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Cynthia Wong
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Number of Participants With Need for Additional Uterotonics (Methylergonovine, Carboprost, Misoprostol)
研究概览
简要总结
Postpartum hemorrhage remains a leading cause of maternal morbidity and mortality worldwide, even in high income countries. Uterine atony is estimated to cause 70-80% of postpartum hemorrhage. Prolonged labor and augmented labor are known risk factors for postpartum hemorrhage. In attempts to reduce the incidence of postpartum hemorrhage, particularly in patients with known risks factors, it is essential to optimize preventative practices in order to reduce the rates postpartum hemorrhage.
Although oxytocin is considered the first line therapy for preventing and treating uterine atony, early consideration of additional prophylactic uterotonic agents may be indicated in women with prior oxytocin exposure given oxytocin receptor desensitization and down regulation.
As such, investigators sought to examine whether multimodal prophylactic uterotonics (standard oxytocin + methylergonovine), in patients who are increased risk of developing postpartum hemorrhage (specifically laboring patients who ultimately require a cesarean section) would benefit from the addition of prophylactic uterotonics. The clinical rational for administration of multimodal prophylactic uterotonics at the time of cesarean delivery in laboring patients is three-fold: to decrease the incidence of uterine atony, to decrease the incidence of postpartum hemorrhage, decrease the number of uterotonics required at the time of cesarean section.
The primary outcome will be to evaluate the need for additional uterotonic agents (Methylergonovine, Carboprost, Misoprostol) at the time of delivery.
Secondary outcomes will include the incidence of postpartum hemorrhage (quantitative blood loss >1 liter), surgical assessment of uterine tone four minutes following delivery of the placenta, preoperative and postoperative hemoglobin, the need for a blood transfusion, intensive care unit admission, uterine infection (endometritis).
详细描述
All patients who meet eligibility for the study will be consented during their clinic visit or upon arrival to labor and delivery. If patients elect to participate in the study, enrollment in the study will be noted in their sticky note in EPIC (electronic medical record) which will be ready available to all members of the health care team. If patients during the labor process require a cesarean section, the anesthesiologist will pick up a sealed envelope (which will contain the allocation sequence and group assignment). A randomization block design with mixed block sizes will be used to generate the allocation sequence by using the nQuery Advisor computer software.
The sealed envelopes will be readily available to the anesthesiologist and kept in the anesthesia workroom. Following delivery of the infant, the patient will receive the standard oxytocin infusion. Following administration of the oxytocin infusion, the patient will be given either methylergonovine 0.2 mg IM (intramuscular) or placebo (1 ml of normal saline, intramuscular). This will be drawn up and administered by the anesthesiologist. The obstetrician (delivering provider performing the cesarean section) will be blinded to the group assignment. Documentation of the drug will be recorded in epic in the medication administration record.
The delivering provider will be responsible for determining and relaying to the anesthesiologist whether additional uterotonics are needed throughout the procedure. Additional uterotonics will be given in accordance to the current guidelines outlined by the American Congress of Obstetricians and Gynecologists (ACOG). The delivery provider will assess uterine tone at 4 minutes (satisfactory versus unsatisfactory). The registered nurse will be responsible for setting up a timer to let the OB provider know when 4 minutes have passed. Nursing will call out once the 4 minutes have passed and the OB provider will state whether adequate tone was noted. The anesthesiologist will be responsible for documenting whether a placebo/study drug was given and uterine tone after 4 minutes. This documentation will be placed back into the sealed envelope by the anesthesiologist and placed in the anesthesia workroom. Nicole Masse (primary investigator) will be responsible for storing folders in a secured, locked file cabinet within the Maternal Fetal Medicine offices.
As routinely done at the time of cesarean delivery, the registered nurse will be responsible for measuring and documenting the quantitative blood loss. As routinely performed on all are patients who undergo a vaginal or cesarean delivery, preoperative hemoglobin and postoperative day one hemoglobin levels will be collected.
In the event a postpartum hemorrhage was to occur, the obstetrician will then be un-blinded as management of a postpartum hemorrhage will be driven by whether normal saline or methergine was given as part of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years of age
- •Laboring patients who undergo a cesarean section
排除标准
- •Placenta/Uterine Abnormalities
- •Chronic Hypertension, Gestational Hypertension, Preeclampsia
- •HIV/AIDS on protease inhibitors
- •History of Coronary Artery Disease
- •History of Hypersensitivity to Methylergonovine
研究组 & 干预措施
Methylergonovine 0.2 mg
Standard Oxytocin Infusion at the time of Cesarean Section plus 0.2 mg of Intramuscular Methergine
干预措施: Methylergonovine (Drug)
Placebo (Normal Saline)
Standard Oxytocin Infusion at the time of Cesarean Section plus 1 milliliter (mL)of normal saline given intramuscular
干预措施: Normal Saline (placebo) (Drug)
结局指标
主要结局
Number of Participants With Need for Additional Uterotonics (Methylergonovine, Carboprost, Misoprostol)
时间窗: Assessed from the time of cesarean section until 24 hours postdelivery
Categorical Variable (Yes/No) - Depending on whether patients required additional uterotonic agents the outcome measure will be yes or no.
次要结局
- The Difference Between the Preoperative and Postoperative (Postpartum Day 1) Hemoglobin Values(Preoperative hemoglobin level is collected on arrival to labor and delivery prior to the cesarean section, postoperative hemoglobin is collected on postoperative day one.)
- Quantitative Blood Loss(Quantitative Blood Loss is measured at the completion of the cesarean delivery, an average of 2 hours)
- Number of Patients With Unsatisfactory Uterine Tone 4 Min Following Delivery as Assessed by the Obstetrician(Obstetricians will assess the uterine tone 4 minutes following delivery of the infant)
- The Number of Patients Who Required a Blood Transfusion During the Delivery Hospitalization(The need for a blood transfusion during the cesarean section up until hospital discharge (which is typically postpartum day number 3 for patients undergoing cesarean delivery))
研究者
Cynthia Wong
Physician-Professor-DEO
University of Iowa