Optimal Timing of Postpartum Oxytocin Administration in the Era of Delayed Cord Clamping - PROCEEDING (PostpaRtum OxytoCin Era dElayed corD clampING) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Change in Hemoglobin
研究概览
简要总结
Increased blood loss after vaginal or cesarean delivery is one of the top causes of maternal complications. Oxytocin is a common medication given to mothers by IV or an injection to limit the amount of blood loss after delivery. The investigators do not know the best time after delivery that oxytocin should be given. This research is being done to find out if starting the medication oxytocin right after the baby is born or after the placenta comes out decreases the amount of blood lost after birth when we delay cord clamping after birth.
详细描述
The optimal timing of prophylactic oxytocin administration on both maternal and neonatal outcomes has not been definitively established with delayed cord clamping. Maternal considerations include the risk of postpartum hemorrhage, need for additional uterotonic medications, need for maternal transfusion, retained placenta, and postpartum drop in hemoglobin. Neonatal considerations include markers of neonatal well-being such as arterial pH and 5-minute Apgar score, as well as hemoglobin and bilirubin levels. There is currently no protocol on the timing of third stage prophylactic oxytocin and its administration is based on physician/ delivery provider's preference. The investigators propose a quality assessment initiative, through a randomized controlled trial designed to compare the blood loss between administrations of prophylactic oxytocin immediately after delivery of the neonate versus after delivery of the placenta with delayed cord clamping.
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
- Double (Participant, Care Provider)
盲法说明
Randomization will be achieved using a computer generated algorithm. Both patient and provider will be unaware of the allocation arm.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All laboring women (induced, augmented, or spontaneous) at term admitted to Labor and Delivery while comfortable
- •Scheduled cesareans
- •Women aged 18 years or older
- •Admitted at NewYork-Presbyterian Morgan Stanley Children's Hospital (CHONY) or Allen Pavilion Labor and Delivery units
排除标准
- •Multifetal gestation
- •Placental abruption or antepartum hemorrhage
- •Maternal bleeding disorder
- •Known fetal anomaly or anemia
- •Fetal growth restriction with abnormal Doppler
- •Significant maternal anemia (pre-operative hemoglobin ≤ 7g/dL
- •Intrapartum stillbirth
- •Placenta accreta spectrum
- •Abnormal placentation (previa or abruption)
- •Planned cord blood banking
- •Refusal of blood products
- •Any contraindication for delayed cord clamping
- •Maternal history of aortic stenosis or pulmonary hypertension or other severe cardiac structural disease
结局指标
主要结局
Change in Hemoglobin
时间窗: Up to 24 hours
Change defined as greater or equal to 1.0 g/dL (≥ 1 standard deviation (SD)) hemoglobin drop between the two arms following a vaginal delivery and greater or equal to 0.9 g/dL (≥ 1SD) following a cesarean delivery.
次要结局
- Cumulative Maternal Adverse Outcomes(Postpartum, Up to 6 weeks)
- Cumulative Neonatal Adverse Outcomes(Post Delivery, Up to 6 weeks)