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Maternal Fatigue after Postpartum Anemia Treatment with Intravenous Ferric Carboxymaltose vs. Intravenous Ferric Derisomaltose vs. Oral Ferrous Sulphate: A Randomized Controlled Trial
Bombač Tavčar, L., Hrobat, H., Gornik, L., Preložnik Zupan, I., Vidmar Šimic, M., Pečlin, P., Kavšek, G., Lučovnik, M.
Journal of clinical medicine. 2024;13(3)
Abstract
(1) Background: Postpartum anemia is a common maternal complication and is recognized as a cause of impaired quality of life, reduced cognitive abilities, and fatigue. Efficient iron supplementation for the treatment of postpartum anemia is an essential component of high-quality maternal care. The optimal mode of iron supplementation has not been determined yet, whether oral or intravenous. The objective of this study was to compare postpartum anemia treatment with intravenous ferric carboxymaltose, intravenous ferric derisomaltose, and oral ferrous sulfate. (2) Methods: A single-center, open-label, randomized controlled trial. Women with hemoglobin < 100 g/L within 48 h postpartum were randomly allocated to receive intravenous ferric carboxymaltose, intravenous ferric derisomaltose, or oral ferrous sulfate. Intravenous iron was given in one or two doses, while ferrous sulfate was given as two 80 mg tablets once daily. The primary outcome was maternal fatigue measured by the Multidimensional Fatigue Inventory (MFI) six weeks postpartum. Hemoglobin, ferritin, and transferrin saturation levels were analyzed as secondary outcomes. A Kruskal-Wallis test was used for group comparison (p < 0.05 significant). (3) Results: Three hundred women were included. The MFI score at six weeks postpartum did not differ between groups (median 38 (inter-quartile range (IQR) 29-47) in the ferric carboxymaltose group, median 34 (IQR 26-42) in the ferric derisomaltose group, and median 36 (IQR 25-47) in the ferrous sulfate group; p = 0.26). Participants receiving oral iron had lower levels of hemoglobin (135 (131-139) vs. 134 (129-139) vs. 131 (125-137) g/L; p = 0.008), ferritin (273 (198-377) vs. 187 (155-246) vs. 24 (17-37) µg/L; p < 0.001) and transferrin saturation (34 (28-38) vs. 30 (23-37) vs. 24 (17-37) %; p < 0.001) than those receiving ferric carboxymaltose or ferric derisomaltose. (4) Conclusions: Intravenous ferric carboxymaltose, intravenous ferric derisomaltose, and oral ferrous sulfate had similar impacts on maternal fatigue at six weeks postpartum despite improved laboratory parameters in the intravenous groups.
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Low-Dose Elagolix for the Treatment of Heavy Menstrual Bleeding in Patients With Uterine Leiomyomas: A Randomized Controlled Trial
Brown, E., Kroll, R., Li, H., Ng, J., Pinsky, B., Rodriguez, J. W., Thomas, J., Snabes, M. C.
Obstetrics and gynecology. 2023
Abstract
OBJECTIVE To evaluate the safety and efficacy of elagolix 150 mg once-daily monotherapy in patients with heavy menstrual bleeding associated with uterine leiomyomas. METHODS A phase 4, randomized, double-blind, placebo-controlled, 6-month treatment study was conducted in premenopausal patients aged 18-51 years with heavy menstrual bleeding (defined as menstrual blood loss greater than 80 mL during one menstrual cycle) associated with uterine leiomyomas. Patients were randomized 2:1 to receive elagolix 150 mg once daily or placebo. The primary endpoint was reduction in menstrual blood loss volume to less than 80 mL at the final month and at least a 50% reduction in menstrual blood loss volume from baseline to the final month. RESULTS Of 82 randomized patients, 54 received elagolix 150 mg and 28 received placebo. With elagolix, 49.4% (95% CI 35.1-63.8%) of patients met the primary endpoint, compared with 23.3% (95% CI 7.2-39.5%) of patients who received placebo (P=.035). Statistically significant differences between elagolix and placebo in mean reduction of menstrual blood loss from baseline were seen as early as month 1 (P<.05 for months 1-3 and 5). Significantly more patients receiving elagolix experienced suppression of bleeding compared with placebo (P=.036). Greater improvements were observed in the elagolix group (vs placebo) in the proportion of patients with amenorrhea, in hemoglobin concentrations, and in health-related quality of life. No serious or severe adverse events were reported for elagolix, compared with 7.1% of participants in the placebo group having serious adverse events (coronavirus disease 2019 [COVID-19] n=1, enlarged uvula n=1). Three patients (5.6%) discontinued elagolix due to adverse events. CONCLUSION Elagolix 150 mg once-daily monotherapy significantly improved heavy menstrual bleeding associated with uterine leiomyomas compared with placebo in premenopausal patients. Treatment with elagolix 150 mg once daily was generally well-tolerated in this study, with no new safety signals. FUNDING SOURCE AbbVie Inc. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, NCT03886220.
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Induction of labor and risk of postpartum hemorrhage in women with vaginal delivery: A propensity score analysis
Braund, S., Deneux-Tharaux, C., Sentilhes, L., Seco, A., Rozenberg, P., Goffinet, F.
International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics. 2023
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.
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Cut umbilical cord milking (C-UCM) as a mode of placental transfusion in non-vigorous preterm neonates: a randomized controlled trial
Bora, R. L., Bandyopadhyay, S., Saha, B., Mukherjee, S., Hazra, A.
European journal of pediatrics. 2023
Abstract
Routine practice of delayed cord clamping (DCC) is the standard of care in vigorous neonates. However there is no consensus on the recommended approach to placental transfusion in non-vigorous neonates. In this trial, we tried to examine the effect of cut umbilical cord milking (C-UCM) as compared to early cord clamping (ECC) on hematological and clinical hemodynamic parameters in non-vigorous preterm neonates of 30-35 weeks gestation. The primary outcome assessed was venous hematocrit (Hct) at 48 (± 4) hours of postnatal age. The important secondary outcomes assessed were serum ferritin at 6 weeks of age, mean blood pressure in the initial transitional phase along with important neonatal morbidities and potential complications. In this single centre randomized controlled trial, 134 non vigorous neonates of 30-35 weeks gestation were allocated in a 1:1 ratio to either C-UCM (n = 67) or ECC (n = 67). For statistical analysis, unpaired Student t and Chi square or Fisher's exact test were used. The mean Hct at 48 h was higher in the C-UCM group as compared to the control group, 50.24(4.200) vs 46.16(2.957), p < .0001. Also significantly higher was the mean Hct at 12 h, 6 weeks and mean serum ferritin at 6 weeks of age in the milked group (p < .0001). Mean blood pressure at 1 h and 6 h was also significantly higher in the milked arm. Need for transfusion and inotropes was less in the milked group but not statistically significant. No significant difference in potential complications was observed between the groups. Conclusion: C-UCM stabilizes initial blood pressure and results in higher hematocrit and improved iron stores. It can be an alternative to DCC in non-vigorous preterm neonates of 30-35 weeks' gestation. Further large multicentric studies are needed to fully establish its efficacy and safety. Trial registration: CTRI/2021/12/038606; registration date December 14, 2021. What is Known: • DCC is the routinely recommended method of placental transfusion for vigorous neonates but no consensus exist for neonates requiring resuscitation at birth. • C-UCM is easier to perform in non-vigorous neonates but there is paucity of studies in the preterm population. What is New: • C-UCM is effective as well as safe in non-vigorous preterm neonates of 30-35 weeks gestational age. • C-UCM holds promise as an alternative to DCC, especially in resource limited settings and in situations where the later is not feasible.
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Incidence of postpartum depression after treatment of postpartum anaemia with intravenous ferric carboxymaltose, intravenous ferric derisomaltose or oral ferrous sulphate: A randomized clinical trial
Bombač Tavčar, L., Hrobat, H., Gornik, L., Globevnik Velikonja, V., Lučovnik, M.
European journal of obstetrics & gynecology and reproductive biology: X. 2023;20:100247
Abstract
OBJECTIVES This study aimed to explore whether the type of iron preparation used to treat postpartum anaemia affects the incidence of postpartum depression and whether the risk of postpartum depression is higher in postpartum patients with anaemia who were adequately treated compared to the general postpartum population. STUDY DESIGN Single-center, open-label, randomized trial. Women were allocated to receive intravenous ferric carboxymaltose, intravenous ferric derisomaltose or oral ferrous sulphate. Intravenous iron was given in one or two doses, while ferrous sulphate as two 80 mg tablets once daily. Primary outcome was postpartum depression measured by Edinburgh Postnatal Depression Scale (EPDS) six weeks postpartum. Haematological parameters were analyzed as secondary outcomes. Kruskal-Wallis test was used for group comparison (p < 0.05 significant). The chi-square test was applied to compare categorical variables as well as the group of all subjects treated for anaemia in the study with the historical data for the Slovenian postpartum population. RESULTS Three-hundred women with postpartum anemia (hemoglobin < 100 g/L within 48-hours postpartum) were included between September 2020 and March 2022 in tertiary perinatal center. Most characteristics were similar across groups. EPDS score at six weeks postpartum did not differ between groups. The treatment modality of postpartum anaemia did not have a statistically significant effect on the EPDS score six weeks after treatment (p = 0.10), nor did it have a statistically significant effect on the difference in EPDS scores before and after treatment (p = 0.68). The proportions of participants who scored 10 or more points on the EPDS scores at six weeks postpartum were not statistically different between the groups (p = 0.79). The proportion of participants with an EPDS score of 10 or more at six weeks postpartum in the total study population did not differ significantly from previously reported proportion of postpartum women with EPDS score of 10 or more in the general population (12 % vs. 21 %; p < 0.001). CONCLUSIONS Maternal depression at 6 weeks postpartum did not differ in women treated for postpartum anemia with intravenous ferric carboxymaltose, intravenous ferric derisomaltose or oral ferrous sulphate. Participants with postpartum anaemia who are adequately treated with either oral or intravenous iron preparations are not at a higher risk of postpartum depression than the general population at six weeks postpartum.
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Placental cord drainage vs delayed cord clamping at elective caesarean section: A randomised controlled trial
Fahy, M. J., Ko, C., Maynard, M., Kalian, K. N.
The Australian & New Zealand journal of obstetrics & gynaecology. 2023
Abstract
BACKGROUND Placental cord drainage (PCD) after vaginal birth accelerates placental delivery by 2.85 minutes, but reduces blood loss by only 77 mL. AIMS To determine if PCD at elective caesarean section accelerates placental delivery, compared to delayed cord clamping (DCC). MATERIALS AND METHODS This randomised controlled trial randomised 100 women undergoing elective caesarean sections to receive either PCD for 60 sec after birth, or DCC for 60 sec. The primary outcome was time from birth until placental delivery. Secondary outcomes included estimated blood loss (EBL), postoperative haemoglobin drop, rates of postpartum haemorrhage (PPH), manual removal of placenta and blood transfusion. RESULTS There was no significant difference in timing of placental delivery (PCD 122 sec vs DCC 123.5 sec, P = 0.717). There were no significant differences in EBL (PCD 425 mL vs DCC 400 mL, P = 0.858), postoperative haemoglobin drop (PCD 12 g/L vs DCC 15 g/L, P = 0.297), PPH rate (PCD 45.8% vs DCC 44.4%, P = 0.893, relative risk (RR) 1.03, 95% confidence interval (CI) 0.66-1.62), manual removal rate (PCD 2.1% vs DCC 4.4%, P = 0.609, RR 0.47, 95% CI 0.04-4.99) or transfusion rate (PCD 4.2% vs DCC 0%, P = 0.495). CONCLUSIONS PCD did not accelerate placental delivery at caesarean compared with DCC. Given that both PCD and DCC groups had faster placental deliveries than quoted in the literature at caesarean (200 sec), it could be postulated that DCC is mimicking the effect of PCD through passive transfusion to the neonate. This supports routine use of DCC at elective caesarean section.
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Treatment of unfavorable bleeding patterns in contraceptive implant users: a randomized clinical trial of curcumin
Edelman A, Boniface E, Schrote K, Messerle-Forbes M, O'Donnell A, Jensen JT, Han L
American journal of obstetrics and gynecology. 2023
Abstract
BACKGROUND Some users of the etonogestrel contraceptive implant experience bothersome bleeding which can reduce contraceptive satisfaction and continuation. Few strategies exist to manage this bleeding. The exact mechanism of progestin-induced bleeding is unknown but it is likely multi-factorial (e.g. impaired angiogenesis, 'leaky' fragile vasculature, and inflammation). Curcumin, the active ingredient in turmeric, has anti-inflammatory, anti-proliferative, and anti-angiogenic proprieties which may make it a useful agent for implant-associated bothersome bleeding. OBJECTIVE To evaluate whether curcumin decreases frequent or prolonged bleeding or spotting in contraceptive implant users. STUDY DESIGN The study was a randomized, double blind, placebo-controlled trial. We enrolled etonogestrel implant users with frequent or prolonged bleeding or spotting and randomized them to either 600 mg Theracumin HP (Immunovites, Las Vegas, NV) or placebo daily for 30 days. We defined "frequent" as two or more independent bleeding or spotting episodes and "prolonged" as 7 or more consecutive days of bleeding or spotting in a 30-day interval. Implant use was confirmed by clinical exam as well as a negative gonorrhea/chlamydia and pregnancy test. Enrolled participants initiated study treatmentfollowing three consecutive days of bleeding or spotting; if no bleeding or spotting occurred within 30-days of enrollment, subjects were withdrawn from the study. Study treatments were encapsulated to maintain a similar appearance. Participants used text messages to record daily bleeding patterns and study drug compliance. We defined bleeding as a day that required the use of protection with a pad, tampon, or liner, and spotting as a day with minimal blood loss that did not require the use of any protection. Our primary outcome was the total number of days without bleeding or spotting during the 30 days of study drug or placebo exposure. Secondary outcomes including total number of bleeding-free days, bleeding episodes, and satisfaction. A sample size of 22 per group provided 80% power at an alpha 0.05 to demonstrate a 6-day difference between groups. RESULTS From February 2021 to November 2022, 58 individuals enrolled in the study with 93% (n=54) completing 30 days of treatment (curcumin 26, placebo 28). One individual in the curcumin arm did not experience a qualifying bleeding event and thus never initiated treatment and, per protocol, was withdrawn from the study. Participant characteristics did not differ between groups including length of implant use at study enrollment [placebo: 521 days (SD 305), curcumin 419 days (SD 264)]. Study groups did not differ in regard to any bleeding-related outcome [mean days without bleeding or spotting: curcumin 16.7 (SD 6.9), placebo 17.5 (SD 4.8), p = 0.62; mean bleeding-free days: curcumin 23.4 (SD 4.9), placebo 22.4 (SD 4.5), p = 0.44; bleeding episodes: curcumin 2.0 (SD 0.8), placebo 2.1 (SD 0.8), p = 0.63]. Satisfaction with the implant as contraception and acceptability of bleeding over the study period also did not differ by study group (p = 0.54 and p = 0.30, respectively). CONCLUSION Daily use of curcumin did not improve bleeding patterns in users of the etonorgestrel contraceptive implant experiencing frequent or prolonged bleeding patterns.
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A randomized trial comparing the 52-mg levonorgestrel system to combination oral contraceptives for treatment of heavy menstrual bleeding
Matteson, K. A., Valcin, J., Raker, C. A., Clark, M. A.
American journal of obstetrics and gynecology. 2023
Abstract
BACKGROUND The levonorgestrel intrauterine system and combined oral contraceptives are the two most commonly used non-surgical treatments for heavy menstrual bleeding in the United States. However, there are limited data on their relative effectiveness and on their impact on bleeding-specific quality of life. OBJECTIVE To compare the effectiveness of the 52-mg levonorgestrel intrauterine system to combined oral contraceptives for improving quality of life among individuals who self-report heavy menstrual bleeding. We hypothesized that the levonorgestrel intrauterine system would be more effective than combined oral contraceptives at 6 months and 12 months post-treatment. STUDY DESIGN We conducted a pragmatic randomized trial of individuals who self-reported heavy menstrual bleeding. Individuals were eligible if they did not have contraindications to either the levonorgestrel intrauterine system or combined oral contraceptives and were determined to have a non-structural cause of heavy menstrual bleeding. Eligible and consenting participants were randomized in a 1:1 ratio to receive a 52 mg levonorgestrel intrauterine system or a monophasic 30 or 35 mcg ethinyl-estradiol containing combined oral contraceptive. The main outcome was mean change in bleeding-related quality of life, measured by the 20-question Menstrual Bleeding Questionnaire (score range 0-75), at 6 and 12 months. Differences in group means and confidence intervals for the Menstrual Bleeding Questionnaire score were computed by multivariable linear mixed effects regression. Twenty-four participants per group were needed to detect a 10-point difference in change in mean Menstrual Bleeding Questionnaire score between individuals treated with the LNG IUS and individuals treated with COCs at each follow-up timepoint. RESULTS Sixty-two individuals were randomized to treatment (n=29 allocated to levonorgestrel intrauterine system and n=33 allocated to combined oral contraceptives) and included in the intention-to-treat analyses. Nineteen (of the 29) received the levonorgestrel intrauterine system and 31(of the 33) received combined oral contraceptives. Eleven percent identified as Black or African American and 44% identified as Hispanic or Latina. Participant characteristics were similar between study groups. Bleeding- quality of life increased in both study arms as reflected by a significant decrease in Menstrual Bleeding Questionnaire scores beginning at 6 weeks follow-up. In the main intention to treat analyses (n=62), there were no differences in mean change in Menstrual Bleeding Questionnaire scores at 6 months (difference=-2.5, 95% CI -10.0 to +5.0) or 12 months (difference=-1.1, 95% CI -8.7 to +6.5). Findings were similar in the subsets of participants with any follow-up visits (n=52) and who completed all follow-up visits (n=42). In the per-protocol analyses (n=47), a significantly greater decrease in Menstrual Bleeding Questionnaire score was seen in the levonorgestrel intrauterine system arm at 6 months post-treatment (difference= -7.0, 95% CI -13.8 to -0.2) but not at 12 months (difference=-4.8, 95% CI -11.8 to 2.3) when compared to the combined oral contraceptive arm. CONCLUSION No significant differences in change of bleeding-related quality of life were observed between the levonorgestrel intrauterine system and combined oral contraceptives at 6 or 12 months. Patients should be counseled that the levonorgestrel intrauterine system and combined oral contraceptives are both effective options for improving bleeding-related quality of life.
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Comparison of quantitative and calculated postpartum blood loss after vaginal delivery
Madar, H., Sentilhes, L., Goffinet, F., Bonnet, M. P., Rozenberg, P., Deneux-Tharaux, C.
American journal of obstetrics & gynecology MFM. 2023;:101065
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Editor's Choice
Abstract
BACKGROUND Because there is no consensual method of assessing postpartum blood loss, the comparability and relevance of the postpartum hemorrhage-related literature is questionable. Quantitative blood loss assessment using a volumetric technique with a graduated collector bag has been proposed to overcome limitations of intervention-based outcomes but remains partly subjective and potentially biased by amniotic fluid or missed out-of-bag losses. Calculated blood loss based on laboratory parameters has been published and used as an objective method expected to reflect total blood loss, but few studies have compared quantitative with calculated blood loss. OBJECTIVE This study aimed to compare the distribution of postpartum blood loss after vaginal delivery assessed by two methods - quantitative and calculated blood loss - and the incidence of abnormal blood loss with each method. STUDY DESIGN The data came from the merged database of 3 multicenter, randomized controlled trials, all testing different interventions to prevent postpartum blood loss in individuals with a singleton live fetus ≥ 35 weeks, born vaginally. All 3 trials measured blood loss volume by using a graduated collector bag. Hematocrit was measured in the eighth or ninth month of gestation and on day 2 postpartum. The two primary outcomes were: quantitative blood loss defined by the total volume of blood loss measured in a graduated collector bag, and calculated blood loss mathematically defined from the peripartum hematocrit change (estimated blood volume × [(antepartum hematocrit - postpartum hematocrit)/antepartum hematocrit], where estimated blood volume (mL) = booking weight (kg) × 85). We modelled the association between positive quantitative blood loss and positive calculated blood loss with polynomial regression and calculated the Spearman correlation coefficient. RESULTS Among the 8341 individuals included in this analysis, the median quantitative blood loss (100 mL, interquartile range 50-275) was significantly lower than the median calculated blood loss (260 mL, interquartile range 0-630) (P<.05). The incidence of abnormal blood loss was lower with quantitative blood loss than calculated blood loss for blood loss ≥ 500 mL, ≥ 1000 mL and ≥ 2000 mL, respectively, it was 9.6% (799/8341) vs 32.3% (2691/8341), 2.1% (176/8341) vs 11.5% (959/8341), and 0.1% (10/8341) vs 1.4% (117/8341); (P<.05). Quantitative blood loss and calculated blood loss were significantly but moderately correlated (Spearman coefficient=0.44; P<.05). The association between them was not linear, and their difference tended to increase with blood loss. Negative calculated blood loss values occurred in 23% (1958/8341) of individuals; among them, more than 99% (1939/1958) had quantitative blood loss ≤ 500 mL. CONCLUSION Quantitative and calculated blood loss were significantly but moderately correlated after vaginal delivery. However, clinicians should be aware that quantitative blood loss is lower than calculated blood loss, with a difference that tended to rise as blood loss increased.
PICO Summary
Population
Patients who gave birth vaginally, participating in the TRACOR, CYTOCINON, and TRAAP randomised controlled trials (RCTs) in several French maternity units (n= 8,341).
Intervention
This study aimed to compare the distribution of postpartum blood assessed by two methods - quantitative and calculated blood loss - and the incidence of abnormal blood loss with each method.
Comparison
Outcome
The data came from 3 RCTs testing different interventions to prevent postpartum blood loss. All 3 trials measured blood loss volume by using a graduated collector bag. The authors modelled the association between positive quantitative blood loss and positive calculated blood loss with polynomial regression and calculated the Spearman correlation coefficient. The median quantitative blood loss (100 mL, IQR= 50, 275) was significantly lower than the median calculated blood loss (260 mL, IQR= 0, 630). The incidence of abnormal blood loss was lower with quantitative blood loss than calculated blood loss. Quantitative blood loss and calculated blood loss were significantly but moderately correlated (Spearman coefficient= 0.44). The association between them was not linear, and their difference tended to increase with blood loss. Negative calculated blood loss values occurred in 23% (1,958/8,341) of individuals; among them, more than 99% (1,939/1,958) had quantitative blood loss ≤ 500 mL.
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Shock index as a predictor of postpartum haemorrhage after vaginal delivery: Secondary analysis of a multicentre randomised controlled trial
Madar, H., Deneux-Tharaux, C., Sentilhes, L.
BJOG : an international journal of obstetrics and gynaecology. 2023
Abstract
OBJECTIVE To describe the shock index (SI) distribution during the first 2 hours after delivery and to evaluate its performance when measured 15 and 30 minutes after delivery for predicting postpartum haemorrhage (PPH) occurrence in the general population of parturients after vaginal delivery. DESIGN Secondary analysis of a multicentre randomised controlled trial testing prophylactic administration of tranexamic acid versus placebo in addition to prophylactic oxytocin to prevent PPH. SETTING 15 French maternity units in 2015-2016. SAMPLE 3891 women with a singleton live fetus ≥35 weeks, born vaginally. METHODS For each PPH-related predicted outcome, we calculated the area under the receiver operating characteristic curve (AUROC) values of the SI at 15 and 30 minutes after delivery and its predictive performance for SI cut-off values of 0.7, 0.9 and 1.1. MAIN OUTCOME MEASURES Quantitative blood loss ≥1000 ml (QBL ≥1000 ml) measured in a graduated collector bag and provider-assessed clinically significant PPH (cPPH). RESULTS Prevalence of QBL ≥1000 ml and cPPH was respectively 2.7% (104/3839) and 9.1% (354/3891). The distributions of the SI at 15 and 30 minutes after delivery were similar with a median value of 0.73 and 97th percentile of 1.11 for both. The AUROC values of the 15-minute SI for discriminating QBL ≥1000 ml and cPPH were respectively 0.66 (lower limit of the 95% confidence interval [LCI] 0.60) and 0.56 (LCI 0.52); and for the 30-minute SI 0.68 (LCI 0.61) and 0.49 (LCI 0.43). CONCLUSIONS The shock index at 15 and 30 minutes after delivery did not satisfactorily predict either QBL ≥1000 ml or clinical PPH.