A multicenter, double-blind, randomized controlled clinical trial comparing ergometrine with oxytocin and oxytocin alone for prevention of postpartum hemorrhage at cesarean section
10.3760/cma.j.cn112141-20220630-00427
- VernacularTitle:马来酸麦角新碱预防剖宫产术产妇产后出血的多中心随机双盲对照临床研究
- Author:
Guolin HE
1
;
Tianying PAN
;
Xinghui LIU
;
Jing HE
;
Songying ZHANG
;
Ling FENG
;
Weishe ZHANG
;
Jin HE
;
Hong XIN
;
Wei ZHOU
;
Yinli CAO
;
Xiaochun HE
;
Li YAN
;
Yiping YOU
;
Hongyan CUI
;
Fang FANG
;
Xuxia LIANG
;
Qinghua CAI
;
Meng CHEN
;
Tao LI
;
Lin WU
Author Information
1. 四川大学华西第二医院妇产科 出生缺陷与相关妇儿疾病教育部重点实验室，成都 610041
- Keywords:
Cesarean section;
Postpartum hemorrhage;
Ergonovine;
Oxytocin;
Multicenter study;
Randomized controlled trial
- From:
Chinese Journal of Obstetrics and Gynecology
2022;57(11):836-842
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To compare oxytocin combined with ergometrine with oxytocin alone in terms of primary prophylaxis for postpartum hemorrhage (PPH) at the time of cesarean section (CS).Methods:This was a multicenter double-blind randomized controlled interventional study comparing ergometrine combined with oxytocin and oxytocin alone administered at CS. From December 2018 to November 2019, a total of 298 parturients were enrolled in 16 hospitals nationwide. They were randomly divided into experimental group (ergometrine intra-myometrial injection following oxytocin intravenously; 148 cases) and control group (oxytocin intra-myometrial injection following oxytocin intravenously; 150 cases) according to 1∶1 random allocation. The following indexes were compared between the two groups: (1) main index: blood loss 2 hours (h) after delivery; (2) secondary indicators: postpartum blood loss at 6 h and 24 h, placental retention time, incidence of PPH, the proportion of additional use of uterine contraction drugs, hemostatic drugs or other hemostatic measures at 2 h and 24 h after delivery, the proportion requiring blood transfusion, and the proportion of prolonged hospital stay due to poor uterine involution; (3) safety indicators: nausea, vomiting, dizziness and other adverse reactions, and blood pressure at each time point of administration.Results:(1) The blood loss at 2 h after delivery in the experimental group [(402±18) ml] was less than that in the control group [(505±18) ml], and the difference was statistically significant ( P<0.05). (2) The blood loss at 6 h and 24 h after delivery in the experimental group were less than those in the control group, and the differences were statistically significant (all P<0.05). There were no significant differences between the two groups in the incidence of PPH, the proportion of additional use of uterine contraction drugs, hemostatic drugs or other hemostatic measures at 2 h and 24 h after delivery, the proportion requiring blood transfusion, and the proportion of prolonged hospital stay due to poor uterine involution (all P>0.05). (3) Adverse reactions occurred in 2 cases (1.4%, 2/148) in the experimental group and 1 case (0.7%, 1/150) in the control group. There was no significant difference between the two groups ( P>0.05). The systolic blood pressure within 2.0 h and diastolic blood pressure within 1.5 h of drug administration in the experimental group were higher than those in the control group, and the differences were statistically significant ( P<0.05), but the blood pressure of the two groups were in the normal range. Conclusion:The use of ergometrine injection in CS could reduce the amount of PPH, which is safe and feasible.
