How's the Tone? Intravenous Versus Intramuscular Administration of Methylergonovine for Uterine Contraction in Cesarean Sections
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Time to achieve "adequate" uterine tone
研究概览
简要总结
Insufficient uterine tone resulting in atony can potentiate hemorrhage and adverse outcomes for the parturient. Oxytocin is the first pharmacologic agent used, followed by methylergonovine, carboprost, and misoprostol. The American Congress of Obstetricians and Gynecologists (ACOG) recommends the sequential use of oxytocin, followed by methylergonovine, carboprost, misoprostol, then surgical intervention for cases of refractory uterine atony. Many studies have examined the effect and dosage of intravenous uterotonics, including oxytocin.
Although there are anecdotal reports of using intravenous bolus or rapid infusion of methylergonovine, no randomized trial has compared efficacy and side effects of these two routes of administration. Investigators hypothesize that intravenous methylergonovine reduces the time to adequate uterine tone (the tone at which the uterus is adequately contracted to prevent atony after delivery of neonate), decreases the total dose of methylergonovine to contract the uterus, and therefore produces fewer side effects of hypertension, nausea, and vomiting. Reducing the time to achieve adequate uterine tone is likely to decrease postpartum hemorrhage.
详细描述
The United States is one of the few modern countries in which maternal peripartum mortality continues to rise. One of the three most important causes of maternal mortality is severe hemorrhage. Controlling postpartum uterine tone remains an important role for the obstetric anesthesiologist. Insufficient uterine tone resulting in atony can potentiate hemorrhage and adverse outcomes for the parturient. Oxytocin is the first pharmacologic agent used, followed by methylergonovine, carboprost, and misoprostol. The American Congress of Obstetricians and Gynecologists (ACOG) recommends the sequential use of oxytocin, followed by methylergonovine, carboprost, misoprostol, then surgical intervention for cases of refractory uterine atony. Many studies have examined the effect and dosage of intravenous uterotonics, including oxytocin.
Methylergonovine maleate is a semi-synthetic ergot alkaloid. Methylergonovine(200 mcg) is administered intramuscularly when oxytocin has been administered but has not contracted the uterus sufficiently. It is not without side effects, however. Due to its vasoconstrictive properties, methylergonovine has been shown to elevate blood pressures and is avoided in preeclamptic patients who may not tolerate abrupt increases in blood pressures. Although there are anecdotal reports of using intravenous bolus or rapid infusion of methylergonovine, no randomized trial has compared efficacy and side effects of these two routes of administration. Investigators hypothesize that intravenous methylergonovine reduces the time to adequate uterine tone (the tone at which the uterus is adequately contracted to prevent atony after delivery of neonate), decreases the total dose of methylergonovine to contract the uterus, and therefore produces fewer side effects of hypertension, nausea, and vomiting. Reducing the time to achieve adequate uterine tone is likely to decrease postpartum hemorrhage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The patient and obstetrician will all be blinded to group assignments. The anesthesiologist will make and administer the medication, as it is important for timely administration of the methylergonovine when it is asked to be used. The anesthesiologist directly taking care of the patient will not be blinded.
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All patients admitted for elective cesarean section
- •All laboring patients for planned vaginal delivery as these women may have an unplanned cesarean delivery for maternal or for fetal indications
- •Patients not in labor but admitted for non-elective cesarean section
- •Administration of oxytocin prior to administration of methylergonovine, in accordance to the ACOG guideline for postpartum hemorrhage
- •Obstetrician's request for methylergonovine intraoperatively to the anesthesiologist
排除标准
- •Fetus not considered to be of viable gestational age by obstetrical team
- •Patients with hypertension (either chronic or pregnancy-induced, including preeclampsia)
- •Patients with coronary artery disease, established and diagnosed by medical internist or cardiologist
- •Patients taking CYP3A4 inhibitors
- •Patients taking beta blockers.
- •Patients with contraindications to any of the uterotonic agents for whatever medical reason (allergies, for example)
- •Surgeon request for administration of methylergonovine earlier than per protocol due to clinical situation as abovementioned
- •Maternal or obstetrician refusal
- •Patients who require obstetrical intervention before 30 minutes has elapsed
研究组 & 干预措施
IV Methergine
IV methylergonovine group
-IM 0.9% NaCl (1 ml)) + IV methylergonovine (2 mcg/ml) infusion (100 ml)
干预措施: Methylergonovine (Drug)
Conventional
IM methylergonovine group
-200 mcg IM methylergonovine (1 ml) + IV 0.9% NaCl infusion (100 ml)
干预措施: Methylergonovine (Drug)
结局指标
主要结局
Time to achieve "adequate" uterine tone
时间窗: 10 minutes
Our primary objective is to determine the time to achieve "adequate" uterine tone with either intramuscular (IM) dose versus intravenous (IV) dose methylergonovine, when oxytocin has failed to do so in cesarean sections.
次要结局
- Computed blood loss(2 hours)
- Estimated blood loss(2 hours)
- Need for vasopressors(3 minutes)
- Dose that achieves "adequate" uterine tone(3 minutes)
- Need for additional uterotonic agents(3 minutes)
- Frequency of side effects of methylergonovine(30 minutes)