Tranexamic Acid for the Prevention of Blood Loss after Cesarean Delivery.

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.).

Alternative to intensive management of the active phase of the second stage of labor: a multicenter randomized trial (Phase Active du Second STade trial) among nulliparous women with an epidural.

BACKGROUND: There is no consensus on an optimal strategy for managing the active phase of the second stage of labor. Intensive pushing could not only reduce pushing duration, but also increase abnormal fetal heart rate because of cord compression and reduced placental perfusion and oxygenation resulting from the combination of uterine contractions and maternal expulsive forces. Therefore, it may increase the risk of neonatal acidosis and the need for operative vaginal delivery. OBJECTIVE: This study aimed to assess the effect of the management encouraging "moderate" pushing vs "intensive" pushing on neonatal morbidity. STUDY DESIGN: This study was a multicenter randomized controlled trial, including nulliparas in the second stage of labor with an epidural and a singleton cephalic fetus at term and with a normal fetal heart rate. Of note, 2 groups were defined: (1) the moderate pushing group, in which women had no time limit on pushing, pushed only twice during each contraction, and observed regular periods without pushing, and (2) the intensive pushing group, in which women pushed 3 times during each contraction and the midwife called an obstetrician after 30 minutes of pushing to discuss operative delivery (standard care). The primary outcome was a composite neonatal morbidity criterion, including umbilical arterial pH of <7.15, base excess of >10 mmol/L, lactate levels of >6 mmol/L, 5-minute Apgar score of <7, and severe neonatal trauma. The secondary outcomes were mode of delivery, episiotomy, obstetrical anal sphincter injuries, postpartum hemorrhage, and maternal satisfaction. RESULTS: The study included 1710 nulliparous women. The neonatal morbidity rate was 18.9% in the moderate pushing group and 20.6% in the intensive pushing group (P=.38). Pushing duration was longer in the moderate group than in the intensive group (38.8±26.4 vs 28.6±17.0 minutes; P<.001), and its rate of operative delivery was 21.1% in the moderate group compared with 24.8% in the intensive group (P=.08). The episiotomy rate was significantly lower in the moderate pushing group than in the intensive pushing group (13.5% vs 17.8%; P=.02). We found no significant difference for obstetrical anal sphincter injuries, postpartum hemorrhage, or maternal satisfaction. CONCLUSION: Moderate pushing has no effect on neonatal morbidity, but it may nonetheless have benefits, as it was associated with a lower episiotomy rate.

Tranexamic acid for the prevention of blood loss after cesarean among women with twins: a secondary analysis of the TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery randomized clinical trial.

BACKGROUND: Although prophylactic tranexamic acid administration after cesarean delivery resulted in a lower incidence of calculated estimated blood loss of >1000 mL or red cell transfusion by day 2, its failure to reduce the incidence of hemorrhage-related secondary clinical outcomes (TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery trial) makes its use questionable. The magnitude of its effect may differ in women at higher risk of blood loss, including those with multiple pregnancies. OBJECTIVE: This study aimed to compare the effect of tranexamic acid vs placebo to prevent blood loss after cesarean delivery among women with multiple pregnancies. STUDY DESIGN: This was a secondary analysis of the TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery trial data, a double-blind, randomized controlled trial from March 2018 to January 2020 in 27 French maternity hospitals, that included 319 women with multiple pregnancies. Women with a cesarean delivery before or during labor at ≥34 weeks of gestation were randomized to receive intravenously 1 g of tranexamic acid (n=160) or placebo (n=159), both with prophylactic uterotonics. The primary outcome was a calculated estimated blood loss of >1000 mL or a red blood cell transfusion by 2 days after delivery. The secondary outcomes included clinical and laboratory blood loss measurements. RESULTS: Of the 4551 women randomized in this trial, 319 had a multiple pregnancy and cesarean delivery, and 298 (93.4%) had primary outcome data available. This outcome occurred in 62 of 147 women (42.2%) in the tranexamic acid group and 67 of 152 (44.1%) receiving placebo (adjusted risk ratio, 0.97; 95% confidence interval, 0.68-1.38; P=.86). No significant between-group differences occurred for any hemorrhage-related clinical outcomes: gravimetrically estimated blood loss, provider-assessed clinically significant hemorrhage, additional uterotonics, postpartum blood transfusion, arterial embolization, and emergency surgery (P>.05 for all comparisons). CONCLUSION: Among women with a multiple pregnancy and cesarean delivery, prophylactic tranexamic acid did not reduce the incidence of any blood loss-related outcomes.

Tranexamic Acid for the Prevention of Blood Loss after Vaginal Delivery.

BACKGROUND: The use of tranexamic acid reduces mortality due to postpartum hemorrhage. We investigated whether the prophylactic administration of tranexamic acid in addition to prophylactic oxytocin in women with vaginal delivery would decrease the incidence of postpartum hemorrhage. METHODS: In a multicenter, double-blind, randomized, controlled trial, we randomly assigned women in labor who had a planned vaginal delivery of a singleton live fetus at 35 or more weeks of gestation to receive 1 g of tranexamic acid or placebo, administered intravenously, in addition to prophylactic oxytocin after delivery. The primary outcome was postpartum hemorrhage, defined as blood loss of at least 500 ml, measured with a collector bag. RESULTS: Of the 4079 women who underwent randomization, 3891 had a vaginal delivery. The primary outcome occurred in 156 of 1921 women (8.1%) in the tranexamic acid group and in 188 of 1918 (9.8%) in the placebo group (relative risk, 0.83; 95% confidence interval [CI], 0.68 to 1.01; P=0.07). Women in the tranexamic acid group had a lower rate of provider-assessed clinically significant postpartum hemorrhage than those in the placebo group (7.8% vs. 10.4%; relative risk, 0.74; 95% CI, 0.61 to 0.91; P=0.004; P=0.04 after adjustment for multiple comparisons post hoc) and also received additional uterotonic agents less often (7.2% vs. 9.7%; relative risk, 0.75; 95% CI, 0.61 to 0.92; P=0.006; adjusted P=0.04). Other secondary outcomes did not differ significantly between the two groups. The incidence of thromboembolic events in the 3 months after delivery did not differ significantly between the tranexamic acid group and the placebo group (0.1% and 0.2%, respectively; relative risk, 0.25; 95% CI, 0.03 to 2.24). CONCLUSIONS: Among women with vaginal delivery who received prophylactic oxytocin, the use of tranexamic acid did not result in a rate of postpartum hemorrhage of at least 500 ml that was significantly lower than the rate with placebo. (Funded by the French Ministry of Health; TRAAP ClinicalTrials.gov number, NCT02302456 .).

Study protocol. TRAAP - TRAnexamic Acid for Preventing postpartum hemorrhage after vaginal delivery: a multicenter randomized, double-blind, placebo-controlled trial.

BACKGROUND: Postpartum hemorrhage (PPH) is a major cause of maternal mortality, accounting for one quarter of all maternal deaths worldwide. Estimates of its incidence in the literature vary widely, from 3 % to 15 % of deliveries. Uterotonics after birth are the only intervention that has been shown to be effective in preventing PPH. Tranexamic acid (TXA), an antifibrinolytic agent, has been investigated as a potentially useful complement to uterotonics for prevention because it has been proved to reduce blood loss in elective surgery, bleeding in trauma patients, and menstrual blood loss. Randomized controlled trials for PPH prevention after cesarean (n = 10) and vaginal (n = 2) deliveries show that women who received TXA had significantly less postpartum blood loss without any increase in their rate of severe adverse effects. However, the quality of these trials was poor and they were not designed to test the effect of TXA on the reduction of PPH incidence. Large, adequately powered, multicenter randomized controlled trials are required before the widespread use of TXA to prevent PPH can be recommended. METHODS AND DESIGN: A multicenter, double-blind, randomized controlled trial will be performed. It will involve 4000 women in labor for a planned vaginal singleton delivery, at a term ≥ 35 weeks. Treatment (either TXA 1 g or placebo) will be administered intravenously just after birth. Prophylactic oxytocin will be administered to all women. The primary outcome will be the incidence of PPH, defined by blood loss ≥500 mL, measured with a graduated collector bag. This study will have 80 % power to show a 30 % reduction in the incidence of PPH, from 10.0 % to 7.0 %. DISCUSSION: In addition to prophylactic uterotonic administration, a complementary component of the management of third stage of labor acting on the coagulation process may be useful in preventing PPH. TXA is a promising candidate drug, inexpensive, easy to administer, and simple to add to the routine management of deliveries in hospitals. This large, adequately powered, multicenter, randomized placebo-controlled trial seeks to determine if the risk-benefit ratio favors the routine use of TXA after delivery to prevent PPH. TRIAL REGISTRATION: ClinicalTrials.gov NCT02302456 (November 17, 2014).

Vaginal pessary for pelvic organ prolapse: A survey among french gynecological surgeons.

OBJECTIVE: Because pessaries may offer symptomatic improvement for women with pelvic organ prolapse (POP), the study aimed to assess the opinion and knowledge of participants to a french general surgical gynecological congress, about this device. MATERIAL AND METHODS: An anonymous survey was carried out near 150 surgeons attending a congress by handing them a questionnaire. RESULTS: The average age of the 70 respondents was 50 years. 87.7 % were comfortable with fitting and monitoring pessary, 54.3 % think that a pessary can be offered as a first-line treatment in the management of POP. However, main indications of vaginal device are still old women and contraindications to surgery ; 31.4 % do not associate local estrogen therapy with a pessary for postmenopausal women. CONCLUSION: The majority declares to be comfortable with pessaries, is ready to prescribe it as a first-line treatment and use local estrogen if necessary. Even if change of ideas seems to emerge about pessary, a change in beliefs and habits is still necessary. This progress can be achieved through doctors fully informed.

Discontinuation of oxytocin in the active phase of labor.

OBJECTIVE: To show that early discontinuation of oxytocin will not increase the mean duration of the active labor phase in a clinically significant way. DESIGN: Controlled non-inferiority study. SETTING: Department of Obstetrics and Gynecology, University of Caen, Clemenceau Hospital, France. POPULATION: A total of 138 women with singleton pregnancy and a vertex presentation of over 34 gestational weeks, presenting a medical indication of induction of labor or a dystocia at onset of labor, from May 2005 to June 2006. METHODS: Two parallel groups were compared: continuation of oxytocin until delivery versus discontinuation of oxytocin at the onset of the active phase. The clinically acceptable increase in mean duration of the active phase of labor (non-inferiority margin) was set at 60 minutes. MAIN OUTCOME MEASURES: Primary outcome measure was duration of the active labor phase. Secondary outcome measures included total duration of labor, parameters concerning oxytocin use, rates of uterine hyperstimulation and fetal heart rate (FHR) abnormalities, and mode of delivery. Some neonatal outcomes were also analyzed. RESULTS: Equivalence of the two strategies (continuation vs. discontinuation of oxytocin) was not demonstrated (p=0.97 testing for non-inferiority), the active phase even being significantly longer by a mean of 113 minutes (p=0.0001 testing for superiority). The rates of cesarean sections, alterations of FHR and delivery hemorrhage were higher when oxytocin was continued, but not significantly. There were significantly more infants hospitalized in neonatology when oxytocin was continued (p=0.028). CONCLUSIONS: Discontinuation of oxytocin at the onset of the active phase prolongs labor. We found no argument for discontinuing the infusion of oxytocin at the onset of the active phase.

Imaging findings in Essure-related complications: a pictorial review.

Tubal sterilization with Essure inserts has become a prevalent alternative to laparoscopic sterilization because of its minimal invasiveness. It is a well-tolerated ambulatory procedure that provides reliable permanent contraception without the risks associated with laparoscopic surgery and general anesthesia. Correct positioning of the Essure device is necessary to achieve the fibrotic reaction induced by the polyethylene terephthalate fibers, subsequently resulting in tubal occlusion usually within 3 months. After uneventful procedures with satisfactory bilateral placement, only the correct position of the devices needs to be confirmed at follow-up. The imaging techniques used to asses Essure devices may vary depending on the country and its recommendations. The gold-standard test to ascertain tubal occlusion remains the hysterosalpingography but after uneventful procedures, vaginal-ultrasound proved to be a reliable alternative to confirm the proper position of the inserts. Radiologists have been increasingly confronted to post-procedural evaluations and despite the efficiency rate of the Essure device, its use still exposes to a low risk of complications and malfunctions such as unwanted pregnancies, device misplacement, tubal or uterine perforation, and chronic pelvic pain. Unintended pregnancies are mostly due to patient or physician non-compliance and misinterpretation of post-procedural examinations by radiologists which emphasizes the importance of their training in Essure device assessment. This pictorial review discusses the imaging methods used to asses Essure implants and illustrates the possible complications related to them.

Effect of routine controlled cord traction as part of the active management of the third stage of labour on postpartum haemorrhage: multicentre randomised controlled trial (TRACOR).

OBJECTIVE: To assess the impact of controlled cord traction on the incidence of postpartum haemorrhage and other characteristics of the third stage of labour in a high resource setting. DESIGN: Randomised controlled trial. SETTING: Five university hospital maternity units in France. PARTICIPANTS: Women aged 18 or more with a singleton fetus at 35 or more weeks' gestation and planned vaginal delivery. INTERVENTIONS: Women were randomly assigned to management of the third stage of labour by controlled cord traction or standard placenta expulsion (awaiting spontaneous placental separation before facilitating expulsion). Women in both arms received prophylactic oxytocin just after birth. MAIN OUTCOME MEASURE: Incidence of postpartum haemorrhage ≥ 500 mL as measured in a collector bag. RESULTS: The incidence of postpartum haemorrhage did not differ between the controlled cord traction arm (9.8%, 196/2005) and standard placenta expulsion arm (10.3%, 206/2008): relative risk 0.95 (95% confidence interval 0.79 to 1.15). The need for manual removal of the placenta was significantly less frequent in the controlled cord traction arm (4.2%, 85/2033) compared with the standard placenta expulsion arm (6.1%, 123/2024): relative risk 0.69, 0.53 to 0.90); as was third stage of labour of more than 15 minutes (4.5%, 91/2030 and 14.3%, 289/2020, respectively): relative risk 0.31, 0.25 to 0.39. Women in the controlled cord traction arm reported a significantly lower intensity of pain and discomfort during the third stage than those in the standard placenta expulsion arm. No uterine inversion occurred in either arm. CONCLUSIONS: In a high resource setting, the use of controlled cord traction for the management of placenta expulsion had no significant effect on the incidence of postpartum haemorrhage and other markers of postpartum blood loss. Evidence to recommend routine controlled cord traction for the management of placenta expulsion to prevent postpartum haemorrhage is therefore lacking. TRIAL REGISTRATION: ClinicalTrials.gov NCT01044082.

Manual rotation to decrease operative delivery in posterior or transverse positions.

OBJECTIVE: To assess the effect of a policy of manual rotation on the mode of delivery of fetuses in posterior or transverse positions at full dilatation. METHODS: This was a prospective study to compare two policies of management for posterior and transverse positions in two different hospitals (Hospital 1: no manual rotation and Hospital 2: manual rotation). We used univariable and multivariable analyses to study the association between the management policy for posterior and transverse positions at full dilatation in these hospitals and maternal and neonatal outcomes. The principal end point was operative delivery (ie, cesarean or instrumental vaginal delivery). All factors associated with the risk of operative delivery in the univariable analysis (P<.1) were included in the logistic regression models. We then specifically studied whether manual rotation was independently associated with a reduction in operative deliveries. RESULTS: The rate of posterior or transverse positions at full dilatation was 15.9% (n=111) in Hospital 1 and 15.3% (n=220) in Hospital 2 (P=.75). Of the 172 attempts of manual rotation in Hospital 2, 155 (90.1%) were successful. The rate of operative delivery was significantly lower in Hospital 2, which performed manual rotations (23.2% compared with 38.7% in Hospital 1, adjusted odds ratio [OR] 0.52, 95% confidence interval [CI] 0.28-0.95). After multivariable analysis, manual rotation remained significantly associated with a reduction in the risk of operative delivery (adjusted OR 0.45, 95% CI 0.25-0.85). Five-minute Apgar score and arterial pH at birth were similar in the two hospitals. CONCLUSION: For fetuses in posterior or transverse positions at full dilatation, a strategy of manual rotation is associated with a reduction in the rate of operative delivery. LEVEL OF EVIDENCE: III.