Neumann Bethany G, Metgud Mrityunjay C, Hoffman Matthew K, Patil Kamal, Savanur Mahadevi, Hanji Vinutha, Ganachari Madiwalayya S, Somannavar Manjunath, Goudar Shivaprasad S
OB Department of Obstetrics and Gynaecology, Jawaharlal Nehru Medical College, Karnatak Lingayat Education Academy of Higher Education and Research, Belagavi, Karnataka, India (Drs Neumann, Metgud, Patil, Savanur and Hanji).
Department of Obstetrics and Gynecology, ChristianaCare, Newark, DE (Dr Hoffman).
AJOG Glob Rep. 2024 Jan 22;4(1):100316. doi: 10.1016/j.xagr.2024.100316. eCollection 2024 Feb.
Postpartum hemorrhage is a leading cause of maternal morbidity and mortality. Tranexamic acid has proven to be useful in treating hemorrhage from acute blood loss. However, its role in preventing blood loss in women at high risk of postpartum hemorrhage undergoing cesarean delivery is not well studied.
This study aimed to assess the role of tranexamic acid in reducing blood loss during elective and unscheduled cesarean deliveries in women at high risk of postpartum hemorrhage.
This was a prospective, placebo-controlled, randomized controlled trial from March 2021 to February 2022 at the Karnatak Lingayat Education Society Dr. Prabhakar Kore Hospital and Medical Research Centre, Belagavi, India. Women at a high risk of postpartum hemorrhage undergoing cesarean delivery were recruited and randomized to receive either tranexamic acid or placebo (1:1) at least 10 minutes before skin incision. High-risk factors for postpartum hemorrhage included obesity, hypertension, multiparity, previous cesarean delivery, multiple pregnancy, abnormally implanted placenta, placenta previa, abruption, uterine leiomyomas, polyhydramnios, and fetal macrosomia. The primary outcome was blood loss, calculated by a formula using pre- and postoperative hematocrit levels. In addition, gravimetrically measured blood loss was measured and compared between the 2 groups.
A total of 212 women met the inclusion criteria and were randomized (tranexamic acid [n=106] and placebo [n=106]). The mean blood loss estimates were 400.9 mL in the tranexamic acid group and 597.9 mL in the placebo group (<.001). The mean gravimetrically measured blood loss estimates were 379.2 mL in the tranexamic acid group and 431.1 mL in the placebo group (<.001). In addition, there was a significant difference in the fall in hemoglobin levels (1.04 vs 1.61 g/dL) and change in hematocrit levels (3.20% vs 4.95%) from the pre- to postoperative period between the 2 groups (<.001). No difference in the need for additional uterotonics (=.26) or the need for postoperative parental iron (=.18) was noted. No woman was transfused in either group.
High-risk women receiving tranexamic acid had significantly less blood loss than women receiving placebo during cesarean delivery.
产后出血是孕产妇发病和死亡的主要原因。氨甲环酸已被证明可有效治疗急性失血引起的出血。然而，其在预防剖宫产术后有产后出血高风险女性失血方面的作用尚未得到充分研究。
本研究旨在评估氨甲环酸在减少有产后出血高风险女性择期和非计划剖宫产术中失血的作用。
这是一项前瞻性、安慰剂对照、随机对照试验，于2021年3月至2022年2月在印度贝拉尔加维的卡纳塔克林加亚特教育协会普拉巴卡尔·科雷博士医院及医学研究中心进行。招募有产后出血高风险且接受剖宫产的女性，并在皮肤切开前至少10分钟将其随机分为接受氨甲环酸或安慰剂组（1:1）。产后出血的高危因素包括肥胖、高血压、多胎妊娠、既往剖宫产史、多胎妊娠、胎盘植入异常、前置胎盘、胎盘早剥、子宫肌瘤、羊水过多和巨大儿。主要结局指标为失血，通过使用术前和术后血细胞比容水平的公式计算得出。此外，对两组进行重量法测量的失血量进行测量和比较。
共有212名女性符合纳入标准并被随机分组（氨甲环酸组[n = 106]和安慰剂组[n = 106]）。氨甲环酸组的平均失血量估计为400.9 mL，安慰剂组为597.9 mL（P <.001）。氨甲环酸组重量法测量的平均失血量估计为379.2 mL，安慰剂组为431.1 mL（P <.001）。此外，两组术前至术后血红蛋白水平下降（1.04 vs 1.61 g/dL）和血细胞比容水平变化（3.20% vs 4.95%）存在显著差异（P <.001）。在额外使用宫缩剂的需求方面（P =.26）或术后静脉补铁的需求方面（P =.18）未发现差异。两组均无女性接受输血。
剖宫产术中，接受氨甲环酸治疗的高风险女性失血量明显少于接受安慰剂的女性。
