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1.
PLoS One ; 19(5): e0301976, 2024.
Article in English | MEDLINE | ID: mdl-38696427

ABSTRACT

BACKGROUND: Among hypertensive disorders of pregnancy (HDP), eclampsia is a rare but serious event, often considered avoidable. Detailed assessment of the adequacy of care for the women who have eclampsia can help identify opportunities for improvement and for prevention of the associated adverse maternal and neonatal outcomes. OBJECTIVE: 1/ To estimate the incidence and describe the characteristics of women with eclampsia and to compare them with those of women with non-eclamptic hypertensive disorders of pregnancy (HDP)-related severe maternal morbidity (SMM) and of control women without SMM 2/ To analyse the quality of management in women who had eclampsia, at various stages of their care pathway. METHODS: It was a planned ancillary analysis of the EPIMOMS population-based study, conducted in six French regions in 2012-2013. Among the 182,309 maternities of the source population, all women with eclampsia (n = 51), with non-eclamptic HDP-related SMM (n = 351) and a 2% representative sample of women without SMM (n = 3,651) were included. Main outcome was the quality of care for eclampsia assessed by an independent expert panel at three different stages of management: antenatal care, care for pre-eclampsia and care for eclampsia. RESULTS: The eclampsia incidence was 2.8 per 10,000 (95%CI 2.0-4.0). Antenatal care was considered completely inadequate or substandard in 39% of women, as was pre-eclampsia care in 76%. Care for eclampsia was judged completely inadequate or substandard in 50% (21/42), mainly due to inadequate use of magnesium sulphate. CONCLUSION: The high proportion of inadequate quality of care underlines the need for an evidence-based standardisation of care for HDP.


Subject(s)
Eclampsia , Humans , Female , Pregnancy , Eclampsia/epidemiology , Eclampsia/therapy , Adult , Incidence , Prenatal Care/standards , Pre-Eclampsia/epidemiology , Pre-Eclampsia/therapy , France/epidemiology , Young Adult , Maternal Health Services/standards
2.
Sci Rep ; 14(1): 6564, 2024 03 19.
Article in English | MEDLINE | ID: mdl-38503816

ABSTRACT

This study aimed to identify the risk factors for placenta accreta spectrum (PAS) in women who had at least one previous cesarean delivery and a placenta previa or low-lying. The PACCRETA prospective population-based study took place in 12 regional perinatal networks from 2013 through 2015. All women with one or more prior cesareans and a placenta previa or low lying were included. Placenta accreta spectrum (PAS) was diagnosed at delivery according to standardized clinical and histological criteria. Of the 520,114 deliveries, 396 fulfilled inclusion criteria; 108 were classified with PAS at delivery. Combining the number of prior cesareans and the placental location yielded a rate ranging from 5% for one prior cesarean combined with a posterior low-lying placenta to 63% for three or more prior cesareans combined with placenta previa. The factors independently associated with PAS disorders were BMI ≥ 30, previous uterine surgery, previous postpartum hemorrhage, a higher number of prior cesareans, and a placenta previa. Finally, in this high-risk population, the rate of PAS disorders varies greatly, not only with the number of prior cesareans but also with the exact placental location and some of the women's individual characteristics. Risk stratification is thus possible in this population.


Subject(s)
Placenta Accreta , Placenta Previa , Pregnancy , Female , Humans , Placenta Previa/epidemiology , Placenta Previa/etiology , Placenta , Placenta Accreta/epidemiology , Placenta Accreta/etiology , Prospective Studies , Cesarean Section/adverse effects , Risk Factors , Retrospective Studies
3.
Int J Gynaecol Obstet ; 164(2): 732-740, 2024 Feb.
Article in English | MEDLINE | ID: mdl-37568268

ABSTRACT

OBJECTIVE: To explore the association between induction of labor (IOL) and postpartum hemorrhage (PPH) after vaginal delivery. METHODS: We included women from the merged database of three randomized prospective trials (TRACOR, CYTOCINON, and TRAAP) that measured postpartum blood loss precisely, with standardized methods. IOL was considered overall and according to its method. The association between IOL and PPH was tested by multivariate logistic regression modeling, adjusted for confounders, and by propensity score matching. The role of potential intermediate factors, i.e. estimated quantity of oxytocin administered during labor and operative vaginal delivery, was assessed with structural equation modeling. RESULTS: Labor was induced for 1809 of the 9209 (19.6%) women. IOL was associated with a significantly higher risk of PPH of 500 mL or more (adjusted odds ratio 1.56, 95% confidence interval 1.42-1.70) and PPH of 1000 mL or more (adjusted odds ratio 1.51, 95% confidence interval 1.16-1.96). The risk of PPH increased similarly regardless of the method of induction. The results were similar after propensity score matching (odds ratio for PPH ≥500 mL 1.57, 95% confidence interval 1.33-1.87, odds ratio for PPH ≥1000 mL 1.57, 95% confidence interval 1.06-2.07). Structural equation modeling showed that 34% of this association was mediated by the quantity of oxytocin administered during labor and 1.3% by women who underwent operative vaginal delivery. CONCLUSION: Among women with vaginal delivery, the risk of PPH is higher in those with IOL, regardless of its method, and after accounting for indication bias. The quantity of oxytocin administered during labor may explain one third of this association.


Subject(s)
Oxytocics , Postpartum Hemorrhage , Pregnancy , Female , Humans , Male , Postpartum Hemorrhage/epidemiology , Postpartum Hemorrhage/etiology , Oxytocin/adverse effects , Propensity Score , Prospective Studies , Delivery, Obstetric/adverse effects , Labor, Induced/adverse effects , Labor Stage, Third , Oxytocics/adverse effects
4.
Am J Obstet Gynecol ; 229(5): 528.e1-528.e17, 2023 11.
Article in English | MEDLINE | ID: mdl-37499991

ABSTRACT

BACKGROUND: Incontinence occurs frequently in the postpartum period. Several theoretical pathophysiological models may underlie the hypothesis that different types of management of the active phase of the second stage of labor have different effects on pelvic floor muscles and thus perhaps affect urinary and anal continence. OBJECTIVE: This study aimed to evaluate the impact of "moderate pushing" on the occurrence of urinary or anal incontinence compared with "intensive pushing," and to determine the factors associated with incontinence at 6 months postpartum. STUDY DESIGN: This was a planned analysis of secondary objectives of the PASST (Phase Active du Second STade) trial, a multicenter randomized controlled trial. PASST included nulliparous women with singleton term pregnancies and epidural analgesia, who were randomly assigned at 8 cm of dilatation to either the intervention group that used "moderate" pushing (pushing only twice during each contraction, resting regularly for 1 contraction in 5 without pushing, and no time limit on pushing) or the control group following the usual management of "intensive" pushing (pushing 3 times during each contraction, with no contractions without pushing, with an obstetrician called to discuss operative delivery after 30 minutes of pushing). Data about continence were collected with validated self-assessment questionnaires at 6 months postpartum. Urinary incontinence was defined by an ICIQ-UI SF (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form) score ≥1 and anal incontinence by a Wexner score ≥2. A separate analysis was also performed among the more severely affected women (ICIQ-UI SF ≥6 and Wexner ≥5). Factors associated with incontinence were assessed with univariate and multivariable analyses. RESULTS: Among 1618 women initially randomized, 890 (55%) returned the complete questionnaire at 6 months. The rate of urinary incontinence was 36.6% in the "moderate" pushing group vs 38.5% in the "intensive" pushing group (relative risk, 0.95; 95% confidence interval, 0.80-1.13), whereas the rate of anal incontinence was 32.2% vs 34.6% (relative risk, 0.93; 95% confidence interval, 0.77-1.12). None of the obstetrical factors studied related to the second stage of labor influenced the occurrence of urinary or anal incontinence, except operative vaginal delivery, which increased the risk of anal incontinence (adjusted odds ratio, 1.50; 95% confidence interval, 1.04-2.15). CONCLUSION: The results of the PASST trial indicate that neither moderate nor intensive pushing efforts affect the risk of urinary or anal incontinence at 6 months postpartum among women who gave birth under epidural analgesia.


Subject(s)
Fecal Incontinence , Urinary Incontinence , Pregnancy , Female , Humans , Labor Stage, Second/physiology , Delivery, Obstetric/methods , Fecal Incontinence/epidemiology , Postpartum Period , Urinary Incontinence/epidemiology
5.
J Gynecol Obstet Hum Reprod ; 52(8): 102626, 2023 Oct.
Article in English | MEDLINE | ID: mdl-37354968

ABSTRACT

OBJECTIVE: To evaluate the risk of disseminated intravascular coagulation (DIC) in postpartum hemorrhage (PPH) associated with intrauterine infection. MATERIAL AND METHODS: A retrospective cohort study of pregnancies complicated by PPH performed at a tertiary academic center in France from 2017 through 2021. Patients giving birth after 22 weeks of gestation with PPH were eligible. Patients with a PPH associated with an intrauterine infection were compared to patients with a PPH without intrauterine infection. Intrauterine infection was defined by a composite criterion available at delivery. DIC was defined by a specific pregnancy DIC score. The association between DIC and intrauterine infection was assessed by logistic regression. The causal effect of intrauterine infection on DIC was estimated by mediation analysis. RESULTS: Of 2,093 patients with PPH, 49 exposed to a clinical intrauterine infection were compared to 49 unexposed patients. The rate of DIC was higher in patients with than without infection (22 (45.8%) vs. 7 (14.6%), P = .001), and coagulation anomalies occurred sooner in patients with than without infection (7, 2-11 h vs. 14, 9-19 h, P < .001). In the multivariate analysis, intrauterine infection was the only factor independently associated with DIC (adjusted odds ratio 5.01, 95% CI 1.83-13.73). Mediation analysis showed that 14% (95% CI, 0-50%) of this association between intrauterine infection and DIC was mediated by severe PPH, and 86% resulted from the direct effect of intrauterine infection on DIC. CONCLUSION: In PPH, intrauterine infection had a major direct effect on the occurrence, timing, and severity of DIC.


Subject(s)
Disseminated Intravascular Coagulation , Postpartum Hemorrhage , Female , Humans , Pregnancy , Postpartum Hemorrhage/epidemiology , Postpartum Hemorrhage/etiology , Retrospective Studies , Disseminated Intravascular Coagulation/epidemiology , Disseminated Intravascular Coagulation/etiology , Multivariate Analysis , Logistic Models
6.
Am J Obstet Gynecol ; 229(5): 542.e1-542.e14, 2023 11.
Article in English | MEDLINE | ID: mdl-37209893

ABSTRACT

BACKGROUND: Many questions remain about the appropriate use of intrauterine balloon devices in postpartum hemorrhage after vaginal delivery refractory to first-line uterotonics. Available data suggest that early use of intrauterine balloon tamponade might be beneficial. OBJECTIVE: This study aimed to compare the effect of intrauterine balloon tamponade used in combination with second-line uterotonics vs intrauterine balloon tamponade used after the failure of second-line uterotonic treatment on the rate of severe postpartum hemorrhage in women with postpartum hemorrhage after vaginal delivery refractory to first-line uterotonics. STUDY DESIGN: This multicenter, randomized, controlled, parallel-group, nonblinded trial was conducted at 18 hospitals and enrolled 403 women who had just given birth vaginally at 35 to 42 weeks of gestation. The inclusion criteria were a postpartum hemorrhage refractory to first-line uterotonics (oxytocin) and requiring a second-line uterotonic treatment with sulprostone (E1 prostaglandin). In the study group, the sulprostone infusion was combined with intrauterine tamponade by an ebb balloon performed within 15 minutes of randomization. In the control group, the sulprostone infusion was started alone within 15 minutes of randomization, and if bleeding persisted 30 minutes after the start of sulprostone infusion, intrauterine tamponade using the ebb balloon was performed. In both groups, if the bleeding persisted 30 minutes after the insertion of the balloon, an emergency radiological or surgical invasive procedure was performed. The primary outcome was the proportion of women who either received ≥3 units of packed red blood cells or had a calculated peripartum blood loss of >1000 mL. The prespecified secondary outcomes were the proportions of women who had a calculated blood loss of ≥1500 mL, any transfusion, an invasive procedure and women who were transferred to the intensive care unit. The analysis of the primary outcome with the triangular test was performed sequentially throughout the trial period. RESULTS: At the eighth interim analysis, the independent data monitoring committee concluded that the incidence of the primary outcome did not differ between the 2 groups and stopped inclusions. After 11 women were excluded because they met an exclusion criterion or withdrew their consent, 199 and 193 women remained in the study and control groups, respectively, for the intention-to-treat analysis. The women's baseline characteristics were similar in both groups. Peripartum hematocrit level change, which was needed for the calculation of the primary outcome, was missing for 4 women in the study group and 2 women in the control group. The primary outcome occurred in 131 of 195 women (67.2%) in the study group and 142 of 191 women (74.3%) in the control group (risk ratio, 0.90; 95% confidence interval, 0.79-1.03). The groups did not differ substantially for rates of calculated peripartum blood loss pf ≥1500 mL, any transfusion, invasive procedure, and admission to an intensive care unit. Endometritis occurred in 5 women (2.7%) in the study group and none in the control group (P=.06). CONCLUSION: The early use of intrauterine balloon tamponade did not reduce the incidence of severe postpartum hemorrhage compared with its use after the failure of second-line uterotonic treatment and before recourse to invasive procedures.


Subject(s)
Balloon Occlusion , Postpartum Hemorrhage , Uterine Balloon Tamponade , Pregnancy , Female , Humans , Postpartum Hemorrhage/etiology , Delivery, Obstetric/adverse effects , Delivery, Obstetric/methods , Oxytocin , Uterine Balloon Tamponade/adverse effects
7.
BJOG ; 130(13): 1653-1661, 2023 12.
Article in English | MEDLINE | ID: mdl-37226308

ABSTRACT

OBJECTIVE: To assess the incidence and risk factors for severe postpartum haemorrhage (PPH) in women with an anterior low-lying or praevia placenta, prior caesarean and no prenatal suspicion of placenta accreta spectrum (PAS). DESIGN: Population-based study in 176 maternity units in France. POPULATION: All women with anterior low-lying (0-19 mm from the cervical internal os) or praevia placenta, diagnosed prospectively before birth, prior caesarean and no prenatal suspicion of PAS. METHODS: Multivariable logistic regression to identify risk factors for severe PPH in the main population and after exclusion of women with PAS diagnosed only at birth. MAIN OUTCOME MEASURES: Severe PPH defined by a composite criterion either estimated blood loss of ≥1500 ml, transfusion of ≥4 or more units of packed red blood cells, embolisation or surgical treatment. RESULTS: Of the 520 114 women constituting the source population, 230 (0.44/1000 women; 95% confidence interval [CI] 0.38-0.50) met the inclusion criteria. Severe PPH rate was 24.8% (95% CI 19.2-30.4) overall, 27.5% (95% CI 21.8-33.3) in women with placenta praevia and 15.4% (95% CI 10.7-20.0) in women with low-lying placenta. PAS was diagnosed at birth in 22 women (9.9%; 95% CI 5.8-13.4), although previously unsuspected. After their exclusion, severe PPH incidence was 17.3% (95% CI 12.4-22.2). In multivariate analysis, the only factor associated with a higher severe PPH risk was placenta previa (aOR, 3.65; 95%CI, 1.20-15.8). CONCLUSION: Severe PPH is frequent among women with anterior low-lying or praevia placenta and prior caesarean, even after exclusion of women with PAS. The risk of severe PPH for those with praevia is nearly twice that with low-lying placenta.


Subject(s)
Placenta Accreta , Placenta Previa , Postpartum Hemorrhage , Infant, Newborn , Female , Pregnancy , Humans , Postpartum Hemorrhage/epidemiology , Postpartum Hemorrhage/etiology , Postpartum Hemorrhage/therapy , Placenta Previa/surgery , Incidence , Prospective Studies , Cesarean Section/adverse effects , Risk Factors , Placenta Accreta/epidemiology , Placenta , Retrospective Studies
8.
Int J Gynaecol Obstet ; 161(3): 1019-1027, 2023 Jun.
Article in English | MEDLINE | ID: mdl-36527250

ABSTRACT

OBJECTIVE: To assess the association between gestational age at delivery and postpartum severe acute maternal morbidity (SAMM) in twin pregnancies. METHODS: Secondary analysis of the JUMODA cohort, a national, prospective, population-based study of twin pregnancies in France. We excluded women with delivery before 32 weeks of pregnancy, with a fetal death or medical termination, with antepartum SAMM, or with antepartum conditions responsible for postpartum SAMM. The primary outcome was a composite of postpartum SAMM. We assessed the association between gestational age at delivery and SAMM by using multivariable multilevel modified Poisson regression modeling. RESULTS: Among the 7713 women included, 410 (5.3%) developed postpartum SAMM. Compared with the reference category of 37 weeks of pregnancy, the risk of postpartum SAMM was significantly lower for all categories of earlier gestational age at delivery (from an adjusted relative risk [RR] of 0.34, 95% confidence interval [CI] 0.17-0.68 at 32 weeks to an adjusted RR of 0.71, 95% CI 0.54-0.94 at 36 weeks), and did not differ for later gestational ages. CONCLUSION: In twin pregnancies, compared with delivery at 37 weeks of pregnancy, delivery at earlier gestational ages was associated with a lower risk of postpartum SAMM. Continuing pregnancy beyond 37 weeks of pregnancy is not associated with an increased risk of postpartum SAMM.


Subject(s)
Postpartum Period , Pregnancy, Twin , Pregnancy , Female , Humans , Infant, Newborn , Prospective Studies , Gestational Age , Fetal Death
9.
Sci Rep ; 12(1): 18626, 2022 11 03.
Article in English | MEDLINE | ID: mdl-36329149

ABSTRACT

To develop a new tool to assess the global quality of care for post-partum hemorrhage (PPH)-the leading preventable cause of maternal mortality worldwide-and to identify characteristics of maternity units associated with inadequate PPH management. This is a secondary analysis of the EPIMOMS population-based study conducted in 2012-2013 in 119 french maternity units (182,309 women who gave birth). We included women with severe PPH. We first developed a score to quantify the quality of care for PPH. Then, we identified characteristics of the maternity units associated with "inadequate care" defined by a score below the 25th percentile, with multi-level logistic regression adjusted for individual characteristics. The score combined 8 key components of care and took into account delivery mode and PPH cause. For PPH after vaginal delivery, the risk of inadequate care was increased in low versus high-volume maternity units (< 1000 deliveries/year: aOR-2.20 [1.12-4.32], [1000-2000 [deliveries/year: aOR-1.90 [1.02-3.56] compared to ≥ 3500 deliveries/year), in private versus public units (aOR-1.72 [1.00-2.97]), and in low versus high-level of care units (aOR-2.04 [1.24-3.35]). For PPH after cesarean, the only characteristic associated with an increased risk of inadequate care was the absence of 24/24-onsite anesthesiologist (aOR-4.34 [1.41-13.31]). These results indicate where opportunities for improvement are the greatest.


Subject(s)
Postpartum Hemorrhage , Female , Pregnancy , Humans , Postpartum Hemorrhage/epidemiology , Postpartum Hemorrhage/therapy , Postpartum Hemorrhage/etiology , Delivery, Obstetric/adverse effects , Parturition , Maternal Mortality , Logistic Models , Risk Factors
10.
Obstet Gynecol ; 140(6): 958-964, 2022 12 01.
Article in English | MEDLINE | ID: mdl-36357972

ABSTRACT

OBJECTIVE: To characterize the strength and patterns of association between birth weights and severe postpartum hemorrhage in twin pregnancies. METHODS: This was a secondary analysis of the JUMODA (JUmeaux Mode d'Accouchement) cohort, a national, prospective, population-based study of twin deliveries, conducted from February 2014 to March 2015 in France. We excluded patients with a fetal death, medically indicated termination of pregnancy, antepartum hemorrhage, placenta previa, placental abruption, or missing birth weight. The primary outcome was severe postpartum hemorrhage , defined as a postpartum hemorrhage requiring at least one of the following: transfusion of 4 or more units of red blood cells, uterine artery embolization, uterine balloon tamponade, vascular ligation, uterine suture, emergency hysterectomy, admission to an intensive care unit, or postpartum hemorrhage considered severe by the obstetrician or leading to maternal death. The exposure was the sum of the birth weights of the two twins. To assess the association between the sum of twins' birth weights and severe postpartum hemorrhage, we used multilevel multivariable modified Poisson regression modeling. Analyses were conducted for the overall population and by planned and actual mode of delivery. RESULTS: A total of 8,373 patients were analyzed. Severe postpartum hemorrhage occurred in 4.5% (379/8,372, 95% CI 4.1-5.0), from 2.1% (15/722) for a sum of twins' birth weights less than 3,000 g up to 8.8% (12/136) for a sum exceeding 6,500 g. In the multivariable analysis, the association between the sum of the twins' birth weights and severe postpartum hemorrhage was linear, with an adjusted relative risk of severe postpartum hemorrhage of 1.36 (95% CI 1.24-1.49) for each 500-g increase in the sum of twins' birth weights. CONCLUSION: In twin pregnancies, the risk of severe postpartum hemorrhage increased linearly with the sum of the twins' birth weights.


Subject(s)
Postpartum Hemorrhage , Pregnancy, Twin , Female , Pregnancy , Humans , Postpartum Hemorrhage/epidemiology , Postpartum Hemorrhage/etiology , Postpartum Hemorrhage/therapy , Birth Weight , Prospective Studies , Cesarean Section , Placenta , Retrospective Studies
11.
Am J Obstet Gynecol ; 227(4): 639.e1-639.e15, 2022 10.
Article in English | MEDLINE | ID: mdl-35868416

ABSTRACT

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.


Subject(s)
Infant, Newborn, Diseases , Postpartum Hemorrhage , Delivery, Obstetric/methods , Female , Humans , Infant, Newborn , Labor Stage, Second/physiology , Lactates , Placenta , Postpartum Hemorrhage/epidemiology , Pregnancy
13.
J Clin Anesth ; 81: 110874, 2022 10.
Article in English | MEDLINE | ID: mdl-35662057

ABSTRACT

STUDY OBJECTIVE: Fibrinogen concentrate is used to treat severe postpartum hemorrhage despite limited evidence of its effectiveness in obstetric settings. We aimed to explore the association between its administration and maternal outcomes in women with severe postpartum hemorrhage. DESIGN, SETTING AND PATIENTS: This secondary analysis of the EPIMOMS prospective population-based study, exploring severe maternal morbidity, as defined by national expert consensus (2012-2013, 182,309 deliveries, France), included all women with severe postpartum hemorrhage and transfused with red blood cells during active bleeding. MEASUREMENTS: The primary endpoint was maternal near-miss or death, and the secondary endpoint the total number of red blood cells units transfused. INTERVENTIONS: We studied fibrinogen concentrate administration as a binary variable and then by the timing of its administration. We used multivariable analysis and propensity score matching to account for potential indication bias. MAIN RESULTS: Among the 730 women with severe postpartum hemorrhage and transfused, 313 (42.9%) received fibrinogen concentrate, and 142 (19.5%) met near-miss criteria or died. The risk of near-miss or death was not significantly lower among the women treated with fibrinogen concentrate than among those not treated, in either the multivariable analysis (adjusted RR = 1.03; 95% CI, 0.72-1.49; P = 0.855) or the propensity score analysis (RR = 0.85; 95% CI, 0.55-1.32; P = 0.477). Among women treated with fibrinogen concentrate, administration more than three hours after red blood cell transfusion started was associated with a higher risk of near-miss or death than administration before or within 30 min after the transfusion began (adjusted RR = 2.07; 95% CI, 1.10-3.89; P = 0.024). Results were similar for the secondary endpoint. CONCLUSIONS: The use of fibrinogen concentrate in severe postpartum hemorrhage needing red blood cell transfusion during active bleeding is not associated with improved maternal outcomes.


Subject(s)
Hemostatics , Postpartum Hemorrhage , Cohort Studies , Female , Fibrinogen/therapeutic use , Hemostatics/therapeutic use , Humans , Postpartum Hemorrhage/therapy , Pregnancy , Propensity Score , Prospective Studies
14.
BJOG ; 129(10): 1676-1685, 2022 09.
Article in English | MEDLINE | ID: mdl-35384244

ABSTRACT

OBJECTIVE: To compare the management and outcomes of women with placenta accreta spectrum (PAS) in France and the UK. DESIGN: Two population-based cohorts. SETTING: All obstetrician-led hospitals in the UK and maternity hospitals in eight French regions. POPULATION: A cohort of 219 women with PAS in France and a cohort of 154 women with PAS in the UK. METHODS: The management and outcomes of women with PAS were compared between the UK and France. MAIN OUTCOME MEASURES: Median blood loss, severe postpartum haemorrhage (≥3 l), postpartum infection and damage to surrounding organs. RESULTS: The management of PAS differed between the two countries: a larger proportion of women with PAS in the UK had a caesarean hysterectomy compared with France (43% vs 26%, p < 0.001), whereas in France a larger proportion of women with PAS received a uterus-preserving approach compared with the UK (36% vs 19%, p < 0.001). The total median blood loss in the UK was 3 l (IQR 1.7-6.5 l), compared with 1 l (IQR 0.5-2.5 l) in France; more women with PAS had a severe postpartum haemorrhage (PPH) in the UK compared with women with PAS in France (58% vs 21%, p < 0.001) [Correction added on 06 May 2022, after first online publication: '24 hour' has been changed to 'total' in the preceding sentence]. There was no difference between the UK and French populations for postpartum infection or organ damage. CONCLUSIONS: The UK and France have very different approaches to managing PAS, with more women in France receiving a uterine-conserving approach and more women in the UK undergoing caesarean hysterectomy. A life-threatening haemorrhage was more common in the UK than in France, which may be the result of differential management and/or the organisation of the healthcare systems. In women with placenta accreta spectrum, severe haemorrhage was more common in the UK than in France. TWEETABLE ABSTRACT: In women with placenta accreta spectrum, severe haemorrhage was more common in the UK than in France.


Subject(s)
Placenta Accreta , Postpartum Hemorrhage , Cesarean Section , Female , Humans , Hysterectomy , Placenta Accreta/epidemiology , Placenta Accreta/surgery , Postpartum Hemorrhage/epidemiology , Postpartum Hemorrhage/surgery , Pregnancy , Retrospective Studies , United Kingdom/epidemiology
16.
Anesth Analg ; 134(3): 581-591, 2022 03 01.
Article in English | MEDLINE | ID: mdl-33989204

ABSTRACT

BACKGROUND: Severe acute maternal morbidity (SAMM) accounts for any life-threatening complication during pregnancy or after delivery. Measuring and monitoring SAMM seem critical to assessing the quality of maternal health care. The objectives were to explore the validity of intensive care unit (ICU) admission as an indicator of SAMM by characterizing the profile of women admitted to an ICU and of their ICU stay, according to the association with other SAMM criterion. METHODS: We performed a secondary analysis of the 2540 women with SAMM included in the epidemiology of severe acute maternal morbidity (EPIMOMS) multiregional prospective population-based study (2012-2013, n = 182,309 deliveries). The EPIMOMS definition of SAMM, based on national experts' consensus, is a combination of diagnosis, organ dysfunctions, and intervention criteria, including ICU admission. Among women with SAMM, we identified characteristics associated with maternal ICU admission with or with no other SAMM criterion compared with ICU admission, by using multivariable multinomial logistic regression models. RESULTS: Overall, 511 women were admitted to an ICU during or up to 42 days after pregnancy, for a population-based rate of 2.8 of 1000 deliveries (511/182,309; 95% confidence interval [CI], 2.6-3.1); 15.5% of them (79/511; 95% CI, 12.4-18.9) had no other SAMM criterion compared with ICU admission. Among women with SAMM, the odds of ICU admission with no other morbidity criterion were increased in women with preexisting medical conditions (adjusted odds ratio (aOR), 2.13; 95% CI, 1.17-3.86) and cesarean before labor (aOR, 3.12; 95% CI, 1.47-6.64). Women admitted to ICU with no other SAMM criterion had more often decompensation of a preexisting condition, no interventions for organ support, and a shorter length of stay than women admitted with other SAMM criteria. CONCLUSIONS: Among women with SAMM, 1 in 5 is admitted to an ICU; 15.5% of those admitted in ICU have no other SAMM criterion and a less acute condition. These results challenge the use of ICU admission as a criterion of SAMM.


Subject(s)
Intensive Care Units/statistics & numerical data , Patient Admission/statistics & numerical data , Pregnancy Complications/epidemiology , Adult , Cesarean Section , Female , Humans , Length of Stay , Maternal Health Services , Population , Preexisting Condition Coverage , Pregnancy , Pregnancy Complications/therapy , Prospective Studies , United States/epidemiology
17.
Am J Obstet Gynecol ; 226(6): 839.e1-839.e24, 2022 06.
Article in English | MEDLINE | ID: mdl-34914894

ABSTRACT

BACKGROUND: Placenta accreta spectrum is a life-threatening condition that has increased dramatically in recent decades along with cesarean rates worldwide. Cesarean hysterectomy is widely practiced in women with placenta accreta spectrum; however, the maternal outcomes after cesarean hysterectomy have not been thoroughly compared with the maternal outcomes after alternative approaches, such as conservative management. OBJECTIVE: This study aimed to compare the severe maternal outcomes between women with placenta accreta spectrum treated with cesarean hysterectomy and those treated with conservative management (leaving the placenta in situ). STUDY DESIGN: From a source population of 520,114 deliveries in 176 hospitals (PACCRETA study), we designed an observational cohort of women with placenta accreta spectrum who had either a cesarean hysterectomy or a conservative management (the placenta left in situ) during cesarean delivery. Clinicians prospectively identified women meeting the inclusion criteria and included them at delivery. Data collection started only after the women had received information and agreed to participate in the study in the immediate postpartum period. The primary outcome was the transfusion of >4 units of packed red blood cells within 6 months after delivery. Secondary outcomes were other maternal complications within 6 months. We used propensity score weighting to account for potential indication bias. RESULTS: Here, 86 women had conservative management and 62 women had cesarean hysterectomy for placenta accreta spectrum during cesarean delivery. The primary outcome occurred in 14 of 86 women in the conservative management group (16.3%) and 36 of 61 (59.0%) in the cesarean hysterectomy group (risk ratio in propensity score weighted model, 0.29; 95% confidence interval, 0.19-0.45). The rates of hysterectomy, total estimated blood loss exceeding 3000 mL, any blood product transfusion, adjacent organ injury, and nonpostpartum hemorrhage-related severe maternal morbidity were lower with conservative management than with cesarean hysterectomy (all adjusted, P≤.02); but, the rates of arterial embolization, endometritis, and readmission within 6 months of discharge were higher with conservative management than with cesarean hysterectomy. CONCLUSION: Among women with placenta accreta spectrum who underwent cesarean delivery, conservative management was associated with a lower risk of transfusion of >4 units of packed red blood cells within 6 months than cesarean hysterectomy.


Subject(s)
Placenta Accreta , Cesarean Section , Conservative Treatment , Female , Humans , Hysterectomy , Placenta Accreta/epidemiology , Placenta Accreta/surgery , Pregnancy , Prospective Studies , Retrospective Studies
18.
Obstet Gynecol ; 139(1): 63-72, 2022 01 01.
Article in English | MEDLINE | ID: mdl-34856568

ABSTRACT

OBJECTIVE: To assess the prevalence of posttraumatic stress disorder (PTSD) symptoms and identify characteristics associated with it 2 months after singleton vaginal delivery at or near term. METHODS: We conducted an ancillary cohort study of the TRAAP (TRAnexamic Acid for Preventing postpartum hemorrhage after vaginal delivery) randomized controlled trial in 15 French hospitals in 2015-2016. Women who had singleton vaginal delivery after 35 weeks of gestation were enrolled. After randomization, characteristics of labor and delivery were prospectively collected and paid special attention to postpartum blood loss. Posttraumatic stress disorder profile and provisional diagnosis were assessed 2 months after childbirth by two self-administered questionnaires: the IES-R (Impact of Event Scale-Revised) and the TES (Traumatic Event Scale). Associations between potential risk factors and PTSD symptoms were analyzed by multivariable logistic or linear regression modeling, depending on the type of dependent variable. RESULTS: Questionnaires were returned by 2,740 of 3,891 women for the IES-R and 2,785 of 3,891 women for the TES (70.4% and 71.6% response rate). The prevalence of PTSD symptoms was 4.9% (95% CI 4.1-5.8%; 137/2,785) with the TES, and the prevalence of PTSD provisional diagnosis was 1.6% (95% CI 1.2-2.1%; 44/2,740), with the IES-R and 0.4% (95% CI 0.2-0.8%; 9/2,080) with the TES. Characteristics associated with a higher risk of PTSD in multivariable analysis were vulnerability factors - notably migrant status and history of psychiatric disorder (adjusted odds ratio [aOR] 2.7 95% CI 1.4-5.2) - and obstetric factors - notably induced labor (aOR 1.5 95% CI 1.0-2.2), being labor longer than 6 hours (aOR 1.7 95% CI 1.1-2.5), postpartum hemorrhage of 1,000 mL or more (aOR 2.0 95% CI 1.0-4.2), and bad memories of delivery at day 2 postpartum (aOR 4.5 95% CI 2.4-8.3) as assessed with the IES-R. Results were similar with the TES. CONCLUSION: Approximately 1 of 20 women with vaginal delivery have PTSD symptoms at 2 months postpartum. History of psychiatric disorder, postpartum hemorrhage, and bad memories of deliveries at day 2 were the main factors associated with a PTSD profile.


Subject(s)
Delivery, Obstetric , Puerperal Disorders/psychology , Stress Disorders, Post-Traumatic/psychology , Adult , Cohort Studies , Diagnostic and Statistical Manual of Mental Disorders , Double-Blind Method , Female , France , Humans , Pregnancy , Psychometrics , Risk Factors , Surveys and Questionnaires
19.
Paediatr Perinat Epidemiol ; 36(2): 171-180, 2022 03.
Article in English | MEDLINE | ID: mdl-34964499

ABSTRACT

BACKGROUND: Severe maternal morbidity (SMM) is a key indicator of maternal health. Generally explored without distinction by the timing of the event, it mainly reflects postpartum SMM. Although antepartum (pre-labour) SMM presents specific challenges in its need to optimise the risk-benefit balance for both mother and foetus, its features remain inadequately explored. OBJECTIVES: We explored risk factors of antepartum SMM and described adverse delivery and neonatal outcomes associated with antepartum SMM. METHODS: We designed a population-based nested case-control study based on data from the EPIMOMS study (119 maternity hospitals of 6 French regions, 2012-2013, N = 182,309 deliveries in the source cohort). This study included all women with antepartum SMM (cases, n = 601) compared to a randomly selected sample of women who gave birth without SMM in the same hospitals (controls, n = 3651). Antepartum SMM risk factors were identified with multivariable logistic regression following imputations for missing data. RESULTS: Antepartum SMM complicated 0.33% (95% confidence interval [CI] 0.30, 0.36) of pregnancies. Antepartum SMM risk factors were maternal age ≥35 years (adjusted odds ratio [OR] 1.55, 95% CI 1.22, 1.97), increased body mass index (OR for 5 kg/m2 increase, 1.24, 95% CI 1.14, 1.36), maternal birth in sub-Saharan Africa (OR 1.80, 95% CI 1.29, 2.53), pre-existing medical condition (OR 2.56, 95% CI 1.99, 3.30), nulliparity (OR 2.26, 95% CI 1.83, 2.80), previous pregnancy-related hypertensive disorders (OR 4.94, 95% CI 3.36, 7.26), multiple pregnancy (OR 5.79, 95% CI 3.75, 7.26), irregular prenatal care (OR 1.86, 95% CI 1.27, 2.72). For women with antepartum SMM, preterm delivery, neonatal mortality and transfer to the neonatal intensive care unit were 10 times more frequent than for controls. Emergency caesarean and general anaesthesia were more frequent in women with antepartum SMM. CONCLUSIONS: Antepartum SMM is rare but associated with increased rates of adverse delivery and neonatal outcomes.


Subject(s)
Pregnancy Complications , Adult , Case-Control Studies , Female , Humans , Infant, Newborn , Maternal Age , Pregnancy , Pregnancy Complications/etiology , Pregnancy, Multiple , Risk Factors
20.
PLoS One ; 16(1): e0244933, 2021.
Article in English | MEDLINE | ID: mdl-33481835

ABSTRACT

BACKGROUND: This study aimed to compare incidence, management and outcomes of women transfused their blood volume or more within 24 hours during pregnancy or following childbirth. METHODS: Combined analysis of individual patient data, prospectively collected in six international population-based studies (France, United Kingdom, Italy, Australia, the Netherlands and Denmark). Massive transfusion in major obstetric haemorrhage was defined as transfusion of eight or more units of red blood cells within 24 hours in a pregnant or postpartum woman. Causes, management and outcomes of women with massive transfusion were compared across countries using descriptive statistics. FINDINGS: The incidence of massive transfusion was approximately 21 women per 100,000 maternities for the United Kingdom, Australia and Italy; by contrast Denmark, the Netherlands and France had incidences of 82, 66 and 69 per 100,000 maternities, respectively. There was large variation in obstetric and haematological management across countries. Fibrinogen products were used in 86% of women in Australia, while the Netherlands and Italy reported lower use at 35-37% of women. Tranexamic acid was used in 75% of women in the Netherlands, but in less than half of women in the UK, Australia and Italy. In all countries, women received large quantities of colloid/crystalloid fluids during resuscitation (>3·5 litres). There was large variation in the use of compression sutures, embolisation and hysterectomy across countries. There was no difference in maternal mortality; however, variable proportions of women had cardiac arrests, renal failure and thrombotic events from 0-16%. INTERPRETATION: There was considerable variation in the incidence of massive transfusion associated with major obstetric haemorrhage across six high-income countries. There were also large disparities in both transfusion and obstetric management between these countries. There is a requirement for detailed evaluation of evidence underlying current guidance. Furthermore, cross-country comparison may empower countries to reference their clinical care against that of other countries.


Subject(s)
Blood Transfusion/statistics & numerical data , Delivery, Obstetric/statistics & numerical data , Internationality , Observational Studies as Topic , Adult , Data Collection , Female , Humans , Pregnancy
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