Aortic Compression Trial - a Randomized Controlled Trial to Reduce Blood Loss at Cesarean Section (ACT)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 2,246
- 试验地点
- 1
- 主要终点
- Calculated peripartum hemorrhage
研究概览
简要总结
The goal of this clinical trial is to test if manual external aortic compression can prevent heavy blood loss in cesarean section. The main question[s] it aims to answer are:
- Is external aortic compression effective?
- Is external aortic compression safe?
Participants will receive preventive manual external aortic compression or no external aortic compression (standard care) immediately after the baby is out at cesarean section. Blood loss will be measured, as well as kidney function, hemoglobin, and hematocrit before and after the operation. Experienced discomfort will be assessed the day after surgery and breastfeeding and signs of depression will be assessed using questionnaires after 2 months.
Researchers will compare women with and without manual external aortic compression to see if there are differences in these outcomes.
详细描述
The Aortic Compression Trial (ACT) - A randomized controlled trial to reduce blood loss in cesarean delivery
PURPOSE AND AIMS The purpose is to reduce the prevalence of severe postpartum hemorrhage (PPH), causing maternal mortality and morbidity worldwide. The aim is to investigate if routine manual external aortic compression (EAC) in cesarean delivery (CD) is an effective and safe measure to prevent severe PPH, in a multicenter randomized controlled superiority trial.
SURVEY OF THE FIELD Severe PPH is defined as blood loss >1000 ml at childbirth. Severe PPH is associated with 25% of maternal mortality worldwide and the leading cause of severe morbidity, such as cardiac, respiratory or renal failure and hysterectomy, notably in low-income countries. PPH also entails blood transfusion, anemia, prolonged postpartum recovery, and depression. The global prevalence of severe PPH is 6%. In Sweden, severe PPH occurs in 7% in vaginal birth, 12% in elective CD, and 17% in emergency CD with large variation between hospitals. Routine intravenous oxytocin is recommended to prevent PPH in CD. Several mechanical methods may treat excessive bleeding, but none has been assessed for prevention of PPH. One method for temporizing blood loss is manual external aortic compression (EAC), usually applied until appropriate care is available, for example during transport. The aorta is compressed by placing a fist onto the aorta through the abdominal wall which cuts off the blood supply to the uterus and hence reduces uterine bleeding. A Cochrane review in 2020 (by Kellie et al) stated that high-quality randomized trials into mechanical and surgical methods for the treatment of PPH are urgently needed. Swedish SBU stated in 2022 that prevention of complications in CD is a top prioritized research area. WHO stated in the Global Summit on PPH 2023 that research on PPH should be prioritized to reach global goals on maternal health. The effect or safety of preventive manual EAC has never been evaluated in a clinical trial.
STUDY DESIGN A multicenter randomized controlled superiority trial (RCT) using 1:1 randomization and intention-to-treat analysis. Randomization will be stratified by site using randomized permuted blocks. Core outcomes for prevention of PPH will be reported (8).
Main research questions
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 (Investigator, Outcomes Assessor)
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
- •Planned cesarean delivery
- •Live fetus/fetuses if multiple pregnancy
- •Gestational week 34+0 or more
排除标准
- •Preoperative B-Hemoglobin <100 g/l
- •Planned hysterectomy in the same procedure as the planned cesarean delivery
- •Other condition as deemed by attending surgeon.
研究组 & 干预措施
Routine external aortic compression
The assistant surgeon or nurse places heel of the hand or fist over the abdominal aorta immediately after the baby is born while the surgeon helps the baby out, the placenta is expulsed or fetched, and the surgeon gains control over bleeding. The compression should be held until controlled bleedning, for example until the first layer of the uterine incision is sutured. Maximum time of aortic compression is 20 minutes, then a 5 minute break is required, after which compression may be reapplied.
干预措施: External aortic compression (Procedure)
No external aortic compression
No routine aortic compression. If deemed vital to the mother, aortic compression should be exerted. Aortic compression may be exerted if bleeding exceeds 1000 ml.
结局指标
主要结局
Calculated peripartum hemorrhage
时间窗: 0-2 days postpartum
Calculated estimated blood loss greater than 1000 ml or a red-cell transfusion within 48 hours after delivery. The calculated estimated blood loss = the estimated blood volume × (preoperative hematocrit - postoperative hematocrit) ÷ preoperative hematocrit. The estimated blood volume in milliliters is calculated as the admission body weight in kilograms × 85.
次要结局
- Total blood loss(0-1 days postpartum)
- Transfusion(0-2 days postpartum)
- Gravimetrically estimated peripartum hemorrhage (g) or blood transfusion(0-2 hours postpartum)
- Maternal higher-level care(0-7 days postpartum)
- Severe maternal morbidity(0-42 days postpartum)
研究者
Sophia Brismar Wendel
Associate professor, MD, PhD
Karolinska Institutet