Carbetocin Administration for the Prevention of Postpartum Hemorrhage in Twin Deliveries: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in maternal hemoglobin level from baseline to postpartum
研究概览
简要总结
The goal of this clinical trial is to learn if the drug carbetocin works better than standard care to prevent heavy bleeding after childbirth in people carrying twin pregnancies. Heavy bleeding after delivery, also called postpartum hemorrhage, is more common after twin births and can lead to anemia, blood transfusions, and other serious health problems.
In this study, bleeding will be evaluated by measuring how much blood hemoglobin levels drop from before delivery to the day after delivery.
The main questions this study aims to answer are:
- Does giving carbetocin after delivery lower blood loss compared with standard oxytocin treatment?
- Is carbetocin safe and practical to use in twin deliveries?
Researchers will compare carbetocin to standard oxytocin treatment to see which approach better prevents bleeding after twin vaginal or cesarean delivery.
Participants will:
- Be randomly assigned to receive either carbetocin or standard oxytocin after the second twin is delivered
- Have blood tests before delivery and on the day after delivery
- Be followed during their hospital stay and for up to six weeks after delivery for safety outcomes
详细描述
Postpartum hemorrhage is a major cause of maternal morbidity worldwide and occurs more frequently in twin pregnancies compared with singleton deliveries. Uterine overdistension in multiple gestations increases the risk of uterine atony, the leading cause of postpartum hemorrhage. Preventive uterotonic therapy is therefore a central component of routine care following twin delivery.
Carbetocin is a long-acting synthetic analogue of oxytocin that induces sustained uterine contraction and is approved for the prevention of postpartum hemorrhage. Previous randomized trials and meta-analyses have demonstrated that carbetocin is associated with reduced need for additional uterotonic agents and blood transfusion compared with oxytocin, primarily in cesarean deliveries. However, data specific to twin pregnancies are limited, and no randomized controlled trial has directly compared carbetocin with standard oxytocin prophylaxis in a twin population including both vaginal and cesarean deliveries.
This single-center randomized controlled trial is designed to evaluate the effectiveness and safety of prophylactic carbetocin compared with standard oxytocin for the prevention of postpartum hemorrhage in twin deliveries. Pregnant individuals aged 18 years or older with twin pregnancies delivering at or beyond 23 weeks of gestation will be eligible to participate. Following written informed consent, participants will be randomized in a 1:1 ratio to receive either carbetocin or standard oxytocin immediately after delivery of the second twin.
Randomization will be performed using computer-generated permuted block sequences to ensure balanced group allocation. The assigned uterotonic treatment will be administered according to group assignment as part of routine postpartum care. Participants in the intervention group will receive a single intravenous dose of carbetocin, while participants in the control group will receive intravenous oxytocin according to institutional protocol.
Maternal hemoglobin levels will be obtained as part of routine clinical care prior to delivery and again on the first postpartum day. The primary outcome of the study is the change in maternal hemoglobin from before delivery to postpartum day one, serving as an objective measure of postpartum blood loss. Secondary outcomes include estimated blood loss, clinical postpartum hemorrhage, need for additional uterotonic agents, blood product transfusion, use of additional medical or surgical interventions for bleeding, maternal infections, intensive care unit admission, and length of postpartum hospitalization.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant individuals aged ≥18 years
- •Twin pregnancies
- •Gestational age ≥23 weeks
排除标准
- •Known hypersensitivity or contraindication to carbetocin
- •Higher-order multiple gestation (triplets or more)
- •Maternal age <18 years
- •Known placenta accreta spectrum
- •Known bleeding disorder
- •Intrauterine fetal death of one or more fetuses
- •Hyponatremia precluding oxytocin use
- •Planned delivery at a non-participating hospital
研究组 & 干预措施
Carbetocin
Participants in this arm will receive a single intravenous dose of carbetocin immediately after delivery of the second twin, as prophylaxis for postpartum hemorrhage, following either vaginal or cesarean delivery.
干预措施: Carbetocin (Drug)
Oxytocin (Standard Care)
Participants in this arm will receive standard prophylactic oxytocin according to institutional protocol, following either vaginal or cesarean delivery.
干预措施: Oxytocin (Drug)
结局指标
主要结局
Change in maternal hemoglobin level from baseline to postpartum
时间窗: The most recent hemoglobin measurement taken within 30 days prior to delivery to the day after delivery.
The primary outcome is the change in maternal hemoglobin level, defined as the difference between pre-delivery hemoglobin and hemoglobin measured on the day after delivery.
次要结局
- Estimated Blood Loss Measured by Quantitative Clinical Assessment(During delivery (vaginal delivery or cesarean delivery))
- Number of Participants With Early Postpartum Hemorrhage(From delivery up to 24 hours postpartum.)
- Number of Participants With Late Postpartum Hemorrhage(From 24 hours postpartum up to 6 weeks postpartum.)
- Number of Participants Requiring Additional Uterotonic Administration(From delivery up to 6 weeks postpartum)
- Number of Participants Receiving Tranexamic Acid(From delivery up to 6 weeks postpartum)
- Number of Participants Receiving Blood Product Transfusion(From delivery up to 6 weeks postpartum.)
- Number of Blood Products Transfused(From delivery up to 6 weeks postpartum.)
- Post delivery day 1 hemoglobin level.(Post delivery day 1)
- Number of Participants Requiring Intrauterine Balloon Tamponade(From delivery up to 6 weeks postpartum)
- Use of uterine compression sutures (e.g., B-Lynch suture).(From delivery up to 6 weeks postpartum.)
- Number of Participants Undergoing Hysterectomy(From delivery up to 6 weeks postpartum.)
- Number of Participants Admitted to the Intensive Care Unit(From delivery up to 6 weeks postpartum.)
- Number of Participants With Maternal Postpartum Infections(From delivery up to 6 weeks postpartum.)
- Maternal death.(From delivery up to 6 weeks postpartum.)
- Length of postpartum hospitalization.(From delivery up to 6 weeks postpartum)
- Number of Participants Re-admitted Within 6 Weeks Postpartum Due to Bleeding(From delivery up to 6 weeks postpartum.)
- Number of Participants Requiring Additional Surgical Intervention Within 6 Weeks Postpartum(From delivery up to 6 weeks postpartum.)
- Number of Participants Breastfeeding at 6 Weeks Postpartum(6 weeks postpartum.)
- Side effects and adverse outcomes(From delivery up to 24 hours postpartum)
研究者
Avihu Krieger
Principal Investigator and Physician, Department of Obstetrics and Gynecology
Sheba Medical Center