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1.
N Engl J Med ; 384(17): 1623-1634, 2021 04 29.
Article in English | MEDLINE | ID: mdl-33913639

ABSTRACT

BACKGROUND: Prophylactic administration of tranexamic acid has been associated with reduced postpartum blood loss after cesarean delivery in several small trials, but evidence of its benefit in this clinical context remains inconclusive. METHODS: In a multicenter, double-blind, randomized, controlled trial, we assigned women undergoing cesarean delivery before or during labor at 34 or more gestational weeks to receive an intravenously administered prophylactic uterotonic agent and either tranexamic acid (1 g) or placebo. The primary outcome was postpartum hemorrhage, defined as a calculated estimated blood loss greater than 1000 ml or receipt of a red-cell transfusion within 2 days after delivery. Secondary outcomes included gravimetrically estimated blood loss, provider-assessed clinically significant postpartum hemorrhage, use of additional uterotonic agents, and postpartum blood transfusion. RESULTS: Of the 4551 women who underwent randomization, 4431 underwent cesarean delivery, 4153 (93.7%) of whom had primary outcome data available. The primary outcome occurred in 556 of 2086 women (26.7%) in the tranexamic acid group and in 653 of 2067 (31.6%) in the placebo group (adjusted risk ratio, 0.84; 95% confidence interval [CI], 0.75 to 0.94; P = 0.003). There were no significant between-group differences in mean gravimetrically estimated blood loss or in the percentage of women with provider-assessed clinically significant postpartum hemorrhage, use of additional uterotonic agents, or postpartum blood transfusion. Thromboembolic events in the 3 months after delivery occurred in 0.4% of women (8 of 2049) who received tranexamic acid and in 0.1% of women (2 of 2056) who received placebo (adjusted risk ratio, 4.01; 95% CI, 0.85 to 18.92; P = 0.08). CONCLUSIONS: Among women who underwent cesarean delivery and received prophylactic uterotonic agents, tranexamic acid treatment resulted in a significantly lower incidence of calculated estimated blood loss greater than 1000 ml or red-cell transfusion by day 2 than placebo, but it did not result in a lower incidence of hemorrhage-related secondary clinical outcomes. (Funded by the French Ministry of Health; TRAAP2 ClinicalTrials.gov number, NCT03431805.).


Subject(s)
Antifibrinolytic Agents/therapeutic use , Cesarean Section/adverse effects , Postpartum Hemorrhage/prevention & control , Tranexamic Acid/therapeutic use , Administration, Intravenous , Adult , Antifibrinolytic Agents/adverse effects , Blood Transfusion/statistics & numerical data , Double-Blind Method , Female , Humans , Pregnancy , Pulmonary Embolism/etiology , Tranexamic Acid/adverse effects , Venous Thrombosis/etiology
2.
Acta Obstet Gynecol Scand ; 99(5): 637-643, 2020 05.
Article in English | MEDLINE | ID: mdl-31863451

ABSTRACT

INTRODUCTION: Our aim was to identify risk factors for failed induction in morbidly obese patients undergoing the induction of labor at term. MATERIAL AND METHODS: This was a retrospective multicenter study on a cohort of 235 patients with a body mass index greater than 40 kg/m2 and giving birth to a singleton in cephalic presentation, who had an induction of labor from 38 weeks of amenorrhea. Scheduled cesareans and spontaneous vaginal deliveries were excluded. Maternal, peri-partum and neonatal characteristics were analyzed according to the delivery route. RESULTS: In all, 235 patients were included. Of these, 62.5% patients delivered vaginally and 37.5% by cesarean section. The frequency of nulliparity was greater in patients who had a cesarean section (56 [interquartile range, IQR, 38.1] vs 56 [IQR 63.6], P < .001). In multivariate analysis, nulliparity (odds ratio [OR] 2.81, 95% confidence interval [CI] 1.58-4.97], P < .001), low Bishop's score (OR .794, 95% CI .70-.90, P < .001) and weight gain (OR 1.04, 95% CI 1.01-1.08, P = .033) were independent risk factors for failed induction. Umbilical cord pH at birth lower than 7 (0 vs 7 [IQR 8.0], P < .001) and lower than 7.20 (36 [IQR 24.5] vs 35 [IQR 39.8], P = .014) as well as the Apgar at 1 minute (14 [IQR 9.5] vs 17 [IQR 19.3], P = .032) was significantly higher in infants born by cesarean section. CONCLUSIONS: In this cohort, 63% of women with Class III obesity had successful inductions of labor; risk factors for failed induction include nulliparity and unfavorable Bishop score.


Subject(s)
Cesarean Section/methods , Labor, Induced/methods , Obesity, Morbid/complications , Pregnancy Outcome , Adult , Cohort Studies , Delivery, Obstetric/methods , Female , Humans , Pregnancy , Retrospective Studies , Risk Factors
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