Randomized Controlled Trial of IV Nitroglycerin in Cesarean Deliveries After Second Stage Arrest for the Prevention of Uterine Extension
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Number of Participants With Uterine Extension of Hysterotomy
研究概览
简要总结
Randomized controlled clinical trial of IV nitroglycerin at cesarean delivery for second stage arrest of descent to prevent or uterine extension at the hysterectomy site.
详细描述
Intravenous nitroglycerin resulting in uterine relaxation has been standardly utilized for various obstetrics conditions, e.g. breech extraction of second twin in vaginal deliveries, uterine relaxation after tachysystole in labor, prior to external cephalic version, and during difficult fetal extraction during cesarean delivery for arrest of descent in labor. Currently the use of nitroglycerin is at equipoise in obstetrics for difficult cesarean delivery after second stage arrest in labor. The clinical trial will randomize women who undergo cesarean delivery for second stage arrest in labor to receive IV nitroglycerin vs saline at the time of hysterotomy. The primary outcomes will be maternal: uterine extension, blood loss, total fetal extraction time, surgical time; neonatal: cord gases at delivery, apgar scores, admission to neonatal intensive care unit.
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
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women 37weeks or greater gestation diagnosed with second stage arrest of descent undergoing cesarean delivery -
排除标准
- •elective, active phase arrest cesarean delivery, successful operative vaginal delivery
研究组 & 干预措施
Intravenous Nitroglycerin
Subjects will receive IV nitroglycerin at the time of Hysterotomy. Infusion will be stopped once neonate is delivered
干预措施: intravenous nitroglycerin (Drug)
结局指标
主要结局
Number of Participants With Uterine Extension of Hysterotomy
时间窗: During cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
Obstetrician determined whether the subject had an uterine extension.
Umbilical Artery Blood pH
时间窗: At time of cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
Measure of umbilical artery blood pH
Number of Participants With Deliveries After Which Neonate is Admitted to NICU
时间窗: After cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
Number of Participants With Deliveries in Which Cord Blood Base Deficit is More Negative Than or Equal to Negative 12
时间窗: At time of cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
A cord blood base deficit more negative than negative 12 is abnormal and a sign of metabolic acidosis.
APGAR at 5 Minutes
时间窗: Immediately after cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
The APGAR scale is determined by evaluating the newborn baby on five simple criteria -- Appearance, Pulse, Grimace, Activity, Respiration -- on a scale from zero to two, then summing up the five values thus obtained. The resulting APGAR score ranges from zero to 10. Zero is the worst possible score and 10 is the highest possible score.
次要结局
- Total Operative Time in Minutes(After cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest)
- Surgical Blood Loss(During and after cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest)
- Fetal Extraction Time in Seconds(At time of cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest)