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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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The impact of the Safe Delivery Application on knowledge and skills managing postpartum haemorrhage in a low resource setting: a cluster randomized controlled trial in West Wollega region, Ethiopia
Christiansen, A. H., Sørensen, B. L., Boas, I. M., Bedesa, T., Fekede, W., Nielsen, H. S., Lund, S.
Reproductive health. 2023;20(1):91
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Abstract
BACKGROUND Postpartum haemorrhage is one of the leading causes of maternal mortality in low-income countries. Improving health workers' competencies in obstetric emergencies in low-income settings, has been recognized as an important factor in preventing maternal mortality and morbidity. mHealth interventions in maternal and newborn health care has shown the potential to improve health service delivery. Strong study designs such as randomized controlled trials are missing to estimate the effectiveness of the mHealth interventions. METHODS Between August 2013 and August 2014, 70 health facilities in West Wollega Region, Ethiopia were included and randomized to intervention or control in a cluster randomized controlled trial. At intervention facilities birth attendants were provided with a smartphone with the SDA installed. Of 176 midwives and "health extension workers," 130 completed at 12 months follow-up. At baseline and after 6- and 12-months participants were assessed. Knowledge was tested by a Key Feature Questionnaire, skills by an Objective Structured Assessment of Technical Skills in a structured role-play scenario. RESULTS Baseline skills scores were low and comparable with a median of 12/100 in the intervention and the control group. After 6 months skills had doubled in the intervention group (adjusted mean difference 29.6; 95% CI 24.2-35.1 compared to 1·8; 95% CI - 2.7 to 6.3 in the control group). At 12 months skills had further improved in the intervention group (adjusted mean difference 13.3; 95% CI 8.3-18.3 compared to 3.1; 95% CI - 1.0 to 7.3 in the control group). Knowledge scores also significantly improved in the intervention group compared to the control (adjusted mean difference after 12 months 8.5; 95% CI 2.0-15.0). CONCLUSION The Safe Delivery App more than doubled clinical skills for managing postpartum haemorrhage among birth attendants making it an attractive tool to reduce maternal mortality. TRIAL REGISTRATION Clinicaltrial.gov Identifier NCT01945931. September 5, 2013. Maternal mortality caused by postpartum haemorrhage is a major public health concern in many low-income countries. Having access to skilled health care professionals during pregnancy and childbirth can prevent maternal deaths related to postpartum haemorrhage. mHealth interventions like the Safe Delivery App (SDA), a smartphone application, has shown the potential to improve the quality of care in emergency situations related to childbirth in low-income health system settings.This study examines the SDA as a training/education tool for improving health workers’ competencies and performances in managing postpartum haemorrhage. The SDA contained animated instruction videos on how to prevent and treat postpartum haemorrhage and a list of essential drugs and basic equipment.In Ethiopia, 70 health facilities and 176 birth attendants were included in a randomized controlled trial. The intervention group received a smartphone with the SDA installed and half a day of introduction to the use of the app. Birth attendants’ skills and knowledge in managing postpartum haemorrhage in the control and the intervention group were tested at baseline, 6 and 12 months after intervention.Our study found that the SDA is an effective tool to improve and sustain birth attendants’ knowledge and skills in the management of postpartum haemorrhage in a rural, low-resource health system setting in Ethiopia, which confirms findings in other non-randomized studies examining the SDA on the management of postpartum haemorrhage. eng
PICO Summary
Population
Midwives and health extension workers attending deliveries in 70 health facilities in Ethiopia (n= 176).
Intervention
Smartphone application ‘Safe Delivery App’ (SDA), (35 facilities, n= 87).
Comparison
No provision of the SDA (35 facilities, n= 89).
Outcome
The total scores in skills and knowledge tests for management of postpartum haemorrhage were the outcomes of this cluster randomised controlled trial. A total of 130 (74%) health workers completed the 6 and 12 months follow up, 65 in each arm, and were included in the analysis. Baseline skills scores were low and comparable with a median of 12/100 in the intervention and the control group. After 6 months skills had doubled in the intervention group (adjusted mean difference 29.6; 95% CI [24.2, 35.1] compared to 1.8; 95% CI [-2.7, 6.3] in the control group). At 12 months skills had further improved in the intervention group (adjusted mean difference 13.3; 95% CI [8.3, 18.3] compared to 3.1; 95% CI [-1.0, 7.3] in the control group). Knowledge scores also significantly improved in the intervention group compared to the control (adjusted mean difference after 12 months 8.5; 95% CI [2.0, 15.0]).
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Randomized Trial of Early Detection and Treatment of Postpartum Hemorrhage
Gallos I, Devall A, Martin J, Middleton L, Beeson L, Galadanci H, Alwy Al-Beity F, Qureshi Z, Hofmeyr GJ, Moran N, et al
The New England journal of medicine. 2023
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Abstract
BACKGROUND Delays in the detection or treatment of postpartum hemorrhage can result in complications or death. A blood-collection drape can help provide objective, accurate, and early diagnosis of postpartum hemorrhage, and delayed or inconsistent use of effective interventions may be able to be addressed by a treatment bundle. METHODS We conducted an international, cluster-randomized trial to assess a multicomponent clinical intervention for postpartum hemorrhage in patients having vaginal delivery. The intervention included a calibrated blood-collection drape for early detection of postpartum hemorrhage and a bundle of first-response treatments (uterine massage, oxytocic drugs, tranexamic acid, intravenous fluids, examination, and escalation), supported by an implementation strategy (intervention group). Hospitals in the control group provided usual care. The primary outcome was a composite of severe postpartum hemorrhage (blood loss, ≥1000 ml), laparotomy for bleeding, or maternal death from bleeding. Key secondary implementation outcomes were the detection of postpartum hemorrhage and adherence to the treatment bundle. RESULTS A total of 80 secondary-level hospitals across Kenya, Nigeria, South Africa, and Tanzania, in which 210,132 patients underwent vaginal delivery, were randomly assigned to the intervention group or the usual-care group. Among hospitals and patients with data, a primary-outcome event occurred in 1.6% of the patients in the intervention group, as compared with 4.3% of those in the usual-care group (risk ratio, 0.40; 95% confidence interval [CI], 0.32 to 0.50; P<0.001). Postpartum hemorrhage was detected in 93.1% of the patients in the intervention group and in 51.1% of those in the usual-care group (rate ratio, 1.58; 95% CI, 1.41 to 1.76), and the treatment bundle was used in 91.2% and 19.4%, respectively (rate ratio, 4.94; 95% CI, 3.88 to 6.28). CONCLUSIONS Early detection of postpartum hemorrhage and use of bundled treatment led to a lower risk of the primary outcome, a composite of severe postpartum hemorrhage, laparotomy for bleeding, or death from bleeding, than usual care among patients having vaginal delivery. (Funded by the Bill and Melinda Gates Foundation; E-MOTIVE ClinicalTrials.gov number, NCT04341662.).
PICO Summary
Population
Patients undergoing vaginal delivery enrolled in the E-MOTIVE cluster-randomised trial in 80 hospitals across Kenya, Nigeria, South Africa and Tanzania (n= 210,132).
Intervention
Multicomponent clinical intervention, including a calibrated blood-collection drape for early detection of postpartum haemorrhage and a bundle of first-response treatments (uterine massage, oxytocic drugs, tranexamic acid, intravenous fluids, examination, and escalation), supported by an implementation strategy, (intervention group, 40 hospitals).
Comparison
Usual care, estimating blood loss visually and using various interventions for postpartum haemorrhage in accordance with local or national guidelines, (usual-care group, 40 hospitals).
Outcome
The primary outcome was a composite of severe postpartum haemorrhage (blood loss, ≥1000 ml), laparotomy for bleeding, or maternal death from bleeding. Among hospitals and patients with data, a primary-outcome event occurred in 1.6% of the patients in the intervention group, as compared with 4.3% of those in the usual-care group (risk ratio, 0.40; 95% confidence interval (CI), [0.32, 0.50]). Postpartum haemorrhage was detected in 93.1% of the patients in the intervention group and in 51.1% of those in the usual-care group (rate ratio, 1.58; 95% CI [1.41, 1.76]), and the treatment bundle was used in 91.2% and 19.4%, respectively (rate ratio, 4.94; 95% CI [3.88, 6.28]).
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Recombinant von Willebrand factor and tranexamic acid for heavy menstrual bleeding in patients with mild and moderate von Willebrand disease in the USA (VWDMin): a phase 3, open-label, randomised, crossover trial
Ragni, M. V., Rothenberger, S. D., Feldman, R., Nance, D., Leavitt, A. D., Malec, L., Kulkarni, R., Sidonio, R., Jr., Kraut, E., Lasky, J., et al
The Lancet. Haematology. 2023
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BACKGROUND Heavy menstrual bleeding occurs in 80% of women with von Willebrand disease and is associated with iron deficiency and poor response to current therapies. International guidelines indicate low certainty regarding effectiveness of hormonal therapy and tranexamic acid. Although von Willebrand factor (VWF) concentrate is approved for bleeds, no prospective trials guide its use in heavy menstrual bleeding. We aimed to compare recombinant VWF with tranexamic acid for reducing heavy menstrual bleeding in patients with von Willebrand disease. METHODS VWDMin, a phase 3, open-label, randomised crossover trial, was done in 13 haemophilia treatment centres in the USA. Female patients aged 13-45 years with mild or moderate von Willebrand disease, defined as VWF ristocetin cofactor less than 0·50 IU/mL, and heavy menstrual bleeding, defined as a pictorial blood assessment chart (PBAC) score more than 100 in one of the past two cycles were eligible for enrolment. Participants were randomly assigned (1:1) to two consecutive cycles each of intravenous recombinant VWF, 40 IU/kg over 5-10 min on day 1, and oral tranexamic acid 1300 mg three times daily on days 1-5, the order determined by randomisation. The primary outcome was a 40-point reduction in PBAC score by day 5 after two cycles of treatment. Efficacy and safety were analysed in all patients with any post-baseline PBAC scores. The trial was stopped early due to slow recruitment on Feb 15, 2022, by a data safety monitoring board request, and was registered at ClinicalTrials.gov, NCT02606045. FINDINGS Between Feb 12, 2019, and Nov 16, 2021, 39 patients were enrolled, 36 of whom completed the trial (17 received recombinant VWF then tranexamic acid and 19 received tranexamic acid then recombinant VWF). At the time of this unplanned interim analysis (data cutoff Jan 27, 2022), median follow-up was 23·97 weeks (IQR 21·81-28·14). The primary endpoint was not met, neither treatment corrected PBAC score to the normal range. Median PBAC score was significantly lower after two cycles with tranexamic acid than with recombinant VWF (146 [95% CI 117-199] vs 213 [152-298]; adjusted mean treatment difference 46 [95% CI 2-90]; p=0·039). There were no serious adverse events or treatment-related deaths and no grade 3-4 adverse events. The most common grade 1-2 adverse events were mucosal bleeding (four [6%] patients during tranexamic acid treatment vs zero during recombinant VWF treatment) and other bleeding (four [6%] vs two [3%]). INTERPRETATION These interim data suggest that recombinant VWF is not superior to tranexamic acid in reducing heavy menstrual bleeding in patients with mild or moderate von Willebrand disease. These findings support discussion of treatment options for heavy menstrual bleeding with patients based on their preferences and lived experience. FUNDING National Heart Lung Blood Institute (National Institutes of Health).
PICO Summary
Population
Patients aged 13-45 years with mild or moderate von Willebrand disease and heavy menstrual bleeding, enrolled in the VWDMin randomised crossover trial in 13 haemophilia treatment centres in the USA (n= 36).
Intervention
Recombinant von Willebrand factor (VWF) then tranexamic acid (n= 17).
Comparison
Tranexamic acid then recombinant VWF (n= 19).
Outcome
The trial was stopped early due to slow recruitment. Median follow-up was 23.97 weeks (IQR= 21.81, 28.14). The primary outcome was a 40-point reduction in pictorial blood assessment chart (PBAC) score by day 5 after two cycles of treatment. The primary endpoint was not met, neither treatment corrected PBAC score to the normal range. Median PBAC score was significantly lower after two cycles with tranexamic acid than with recombinant VWF (146; 95% CI [117, 199] vs. 213; [152, 298]; adjusted mean treatment difference 46; 95% CI [2, 90]). There were no serious adverse events or treatment-related deaths and no grade 3-4 adverse events. The most common grade 1-2 adverse events were mucosal bleeding (four [6%] patients during tranexamic acid treatment vs. zero during recombinant VWF treatment) and other bleeding (four [6%] vs. two [3%]).
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Randomized Controlled Trial Comparing Ferrous Sulfate and Iron Sucrose in Iron Deficiency Anemia in Pregnancy
Chauhan N, Dogra P, Sharma R, Kant S, Soni M
Cureus. 2023;15(2):e34858
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Abstract
INTRODUCTION Anemia among pregnant women is one of the major health concerns for healthcare workers. The management becomes a concern in the pregnancy where the question arises of which is better the intravenous iron sucrose or the oral ferrous sulfate tablets. To answer this, a randomized control trial comparing both the treatment options in a tertiary care government hospital was set up in the hilly terrains of India. This study discusses the effectiveness and practical aspect of using both, which seems to be the better out of both, and why. METHODS The study was conducted as a parallel-group, open-label randomized controlled trial (RCT) in the Department of Obstetrics and Gynecology of a tertiary care government hospital in India, with approximately 4,000 delivery loads annually. Ethical clearance was obtained from the institute's ethics committee (IEC), and the trial was registered with the Clinical Trial Registry of India (REF/2022/06/055013). Two hundred sixty-eight pregnant women between 18 and 45 years of age with moderate iron deficiency anemia (IDA) (hemoglobin (Hb) 7-9g/dl, microcytic-hypochromic, and serum ferritin <30ng/ml) were included in the study. Patients were randomly divided into two groups: group 1 with 134 patients to receive intravenous iron sucrose and group 2 with 134 patients to receive oral ferrous sulfate tablets. RESULTS The intravenous iron sucrose is superior in terms of tolerability and correction of iron deficiency anemia during pregnancy. CONCLUSION It yields a quicker rise in Hb and serum ferritin with no major side effects. In the difficult terrain of Himachal Pradesh, this makes IV iron sucrose a better option for anemic pregnant women who do not have easy access to health facilities resulting in a large number of them reaching hospitals with moderate to severe anemia at a later gestation.
PICO Summary
Population
Pregnant women with moderate iron deficiency anaemia (n= 268).
Intervention
Intravenous iron sucrose (n= 134).
Comparison
Oral ferrous sulfate tablets (n= 134).
Outcome
All women were followed up at four weeks after drug administration and at 36 weeks of gestation to check for the rise in serum ferritin and haemoglobin (Hb). The mean Hb after four weeks of therapy was 11.76 ± 1.29g/dl and 10.84 ± 0.67g/dl in the intravenous iron sucrose and oral ferrous sulfate group, respectively. The Hb at four weeks post-treatment was significantly higher in the intravenous group compared to the oral group. The mean Hb (g/dl) at 36 weeks of gestation was 12 ± 1.1g/dl and 11.28 ± 0.59g/dl in the intravenous iron sucrose and oral ferrous sulfate groups, respectively. The difference between the two groups was statistically significant. The rise in haemoglobin was 3.48g/dl and was significantly high in the intravenous iron sucrose group compared to the oral ferrous sulfate group which was 2.39g/dl after four weeks of treatment. The rise was 3.6g/dl and 2.82g/dl in the intravenous iron sucrose and oral ferrous sulfate group, respectively, at 36 weeks of gestation, and the difference was significant.
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LIBERTY Randomized Withdrawal Study: Relugolix Combination Therapy for Heavy Menstrual Bleeding Associated With Uterine Fibroids
Al-Hendy, A., Venturella, R., Arjona Ferreira, J. C., Li, Y., Soulban, G., Wagman, R. B., Lukes, A. S.
American journal of obstetrics and gynecology. 2023
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Editor's Choice
Abstract
BACKGROUND In the pivotal LIBERTY 1 and 2 trials and long-term extension (LTE) study, once-daily relugolix combination therapy (relugolix CT: relugolix 40 mg, estradiol 1 mg, norethindrone acetate 0.5 mg) reduced menstrual blood loss (MBL) volume and pain in women with uterine fibroids (UF). Relugolix CT was well tolerated, with preservation of bone mineral density (BMD) through 52 weeks. OBJECTIVE To report the 2-year relugolix CT efficacy and safety results of the phase 3 LIBERTY randomized withdrawal study (RWS). STUDY DESIGN Women with UF-associated heavy menstrual bleeding (HMB) who completed the 24-week LIBERTY 1 or 2 trials followed by the 28-week LTE study (up to 52 weeks total treatment), and who met responder criteria (MBL volume <80 mL and ≥50% reduction from pivotal study baseline at week 48 (Week 24 of LTE) were randomized 1:1 to blinded treatment with relugolix CT or placebo for 52 weeks (total treatment period:104 weeks). For women who had a relapse of HMB during the study (MBL volume ≥80 mL), open-label relugolix CT was offered. Primary endpoint was the proportion of women who maintained MBL volume <80 mL through week 76 (Week 24 of RWS). Secondary endpoints included time to MBL volume ≥80 mL, proportion of women who maintained a MBL volume of <80 mL through week 104 (over the 52-week randomized treatment period), the proportion of women achieving or maintaining amenorrhea at week 76/end-of-treatment and change in UFS-Qol BPD and symptom severity scores. Analyses were performed in the modified intent-to-treat (mITT) population including all randomized women who received ≥1 dose of study drug. RESULTS Of the 229 randomized women (relugolix CT:115, placebo:114), 228 received study drug and 175 (76.7%) completed the RWS. Through week 76, 78.4% of women on relugolix CT maintained MBL volume <80 mL vs 15.1% in the placebo group difference of 63.4% [95%CI:52.9%-73.9%];p < 0.0001). At week 104, 69.8% of women on relugolix CT maintained MBL volume <80 mL vs 11.8% in the placebo group (difference of 58.0% [95%CI:47.0%-69.1%];p<0.0001 ). Through week 104, 88.3% of women on placebo relapsed with HMB (median time to relapse of 5.9 weeks). Among the 89 women in the placebo group who relapsed and received open-label rescue treatment, 87 women responded to relugolix CT, with an MBL volume <80 mL. The proportion of women who achieved or maintained amenorrhea were 57.4% vs 13.3% at week 76 (difference of 44.1% [95%CI:33.10%-55.1];p<0.0001) and 58.3% vs 10.6% at week 104 (difference 47.6% [95%CI:37.0%-58.3%];nominal p<0.0001) for relugolix CT and the placebo group, respectively. Relugolix CT was generally well tolerated; no new safety signals were identified, and the adverse event profile over the second year was consistent with that reported through the first year of treatment. BMD remained stable in women who received relugolix CT from week 52 to week 104. In women continuously treated with relugolix CT up to 2 years, BMD was generally preserved. CONCLUSIONS After 2 years of treatment with relugolix CT, there was evidence of durability of effect in maintaining low MBL volume in women with symptomatic UF. Most women had return of HMB and associated symptoms after treatment cessation, which improved upon retreatment with relugolix CT. Relugolix CT was well tolerated, the adverse event profile remained consistent and mean BMD was generally preserved through 2 years of treatment.
PICO Summary
Population
Women with uterine fibroid-associated heavy menstrual bleeding who completed the 24-week LIBERTY 1 or 2 trials (n= 229).
Intervention
Relugolix combination therapy (CT), (n= 115).
Comparison
Placebo (n= 114).
Outcome
The LIBERTY randomized withdrawal study was conducted to evaluate the 2-year relugolix CT efficacy and safety results. Relugolix CT was generally well tolerated; no new safety signals were identified, and the adverse event profile over the second year was consistent with that reported through the first year of treatment. Bone mineral density (BMD) remained stable in women who received relugolix CT from week 52 to week 104. In women continuously treated with relugolix CT up to 2 years, BMD was generally preserved.
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Effective management of foetal anaemia in Rh(D) alloimmunised pregnant women with intrauterine transfusion: a Systematic Review
Prescott, B., Jackson, D. E.
Hematology, transfusion and cell therapy. 2023
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Editor's Choice
Abstract
BACKGROUND Foetal anaemia is caused by a severe pregnancy complication, haemolytic disease of the foetus and newborn. Intrauterine transfusions (IUTs) are performed to treat foetal anaemia in alloimmunised pregnant women. If left untreated hydrops can develop thereby reducing the chance of survival. Survival rates have improved but the procedure is not without complications. Procedure-related complications can be associated with early gestational age, hence delaying IUT could improve outcomes. This review aims to determine the effectiveness and safety of IUTs by examining survival and mortality rates, procedure-related complications with associated foetal mortality and the influence of hydrops. STUDY DESIGN AND METHOD A systematic review was conducted by searching keywords in four scientific databases from January 2000 to April 2022. A meta-analysis was performed with the OpenMeta-Analyst software using an arcsine transformed proportion with the binary random-effects model and maximum likelihood method. RESULTS Fifteen studies were identified as eligible and used in the meta-analysis. The forest plots all showed statistically significant outcomes with heterogeneity of data. Results indicated a greater foetal survival rate with IUT to treat anaemic foetuses, a low foetal mortality rate, and low risk of procedure-related complications associated with foetal loss but a higher risk of foetal mortality when hydrops is present. CONCLUSION The findings of this systematic review and meta-analysis provide evidence that IUT is a safe and effective treatment for foetal anaemia in the absence of hydrops when experienced personnel perform the procedure to minimise the risk of procedure-related complications.
PICO Summary
Population
Rh(D) alloimmunised pregnant women (15 studies).
Intervention
Systematic review and meta-analysis to determine the effectiveness and safety of intrauterine transfusions (IUTs).
Comparison
Outcome
The forest plots all showed statistically significant outcomes with heterogeneity of data. Results indicated a greater foetal survival rate with IUT to treat anaemic foetuses, a low foetal mortality rate, and low risk of procedure-related complications associated with foetal loss but a higher risk of foetal mortality when hydrops is present.
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Maternal low and high hemoglobin concentrations and associations with adverse maternal and infant health outcomes: an updated global systematic review and meta-analysis
Young MF, Oaks BM, Rogers HP, Tandon S, Martorell R, Dewey KG, Wendt AS
BMC pregnancy and childbirth. 2023;23(1):264
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Abstract
BACKGROUND Growing evidence suggests low and high maternal hemoglobin (Hb) concentrations may have adverse consequences for maternal and child health. There remain questions on specific Hb thresholds to define anemia and high Hb as well as how cutoffs may vary by anemia etiology and timing of assessment. METHODS We conducted an updated systematic review (using PubMed and Cochrane Review) on low (< 110 g/L) and high (≥ 130 g/L) maternal Hb concentrations and associations with a range of maternal and infant health outcomes. We examined associations by timing of Hb assessment (preconception; first, second, and third trimesters, as well as at any time point in pregnancy), varying cutoffs used for defining low and high hemoglobin concentrations and performed stratified analyses by iron-deficiency anemia. We conducted meta-analyses to obtain odds ratios (OR) and 95% confidence intervals. RESULTS The updated systematic review included 148 studies. Low maternal Hb at any time point in pregnancy was associated with: low birthweight, LBW (OR (95% CI) 1.28 (1.22-1.35)), very low birthweight, VLBW (2.15 (1.47-3.13)), preterm birth, PTB (1.35 (1.29-1.42)), small-for-gestational age, SGA (1.11 (1.02-1.19)), stillbirth 1.43 (1.24-1.65)), perinatal mortality (1.75 (1.28-2.39)), neonatal mortality (1.25 (1.16-1.34), postpartum hemorrhage (1.69 (1.45-1.97)), transfusion (3.68 (2.58-5.26)), pre-eclampsia (1.57 (1.23-2.01)), and prenatal depression (1.44 (1.24-1.68)). For maternal mortality, the OR was higher for Hb < 90 (4.83 (2.17-10.74)) than for Hb < 100 (2.87 (1.08-7.67)). High maternal Hb was associated with: VLBW (1.35 (1.16-1.57)), PTB (1.12 (1.00-1.25)), SGA (1.17 (1.09-1.25)), stillbirth (1.32 (1.09-1.60)), maternal mortality (2.01 (1.12-3.61)), gestational diabetes (1.71 (1.19-2.46)), and pre-eclampsia (1.34 (1.16-1.56)). Stronger associations were noted earlier in pregnancy for low Hb and adverse birth outcomes while the role of timing of high Hb was inconsistent. Lower Hb cutoffs were associated with greater odds of poor outcomes; for high Hb, data were too limited to identify patterns. Information on anemia etiology was limited; relationships did not vary by iron-deficiency anemia. CONCLUSION Both low and high maternal Hb concentrations during pregnancy are strong predictors of adverse maternal and infant health outcomes. Additional research is needed to establish healthy reference ranges and design effective interventions to optimize maternal Hb during pregnancy.
PICO Summary
Population
Women during pregnancy or preconception (148 studies, n= 13,839,327).
Intervention
Updated systematic review on low (< 110 g/L) and high (≥ 130 g/L) maternal haemoglobin (Hb) concentrations and associations with adverse maternal and infant health outcomes.
Comparison
Outcome
Low maternal Hb at any time point in pregnancy was associated with: Low birthweight, very low birthweight (VLBW), preterm birth (PTB), small-for-gestational age (SGA), stillbirth, perinatal mortality, neonatal mortality, postpartum haemorrhage, transfusion, pre-eclampsia, and prenatal depression. For maternal mortality, the OR was higher for Hb < 90 (OR, 4.83; 95% CI [2.17, 10.74]) than for Hb < 100 (OR, 2.87; 95% CI [1.08, 7.67]). High maternal Hb was associated with: VLBW, PTB, SGA, stillbirth, maternal mortality, gestational diabetes, and pre-eclampsia. Stronger associations were noted earlier in pregnancy for low Hb and adverse birth outcomes while the role of timing of high Hb was inconsistent.
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Placental Transfusion Strategies in Preterm Infants in Low- and Middle-Income Countries: A Systematic Review and Network Meta-Analysis
Ramaswamy VV, Bandyopadhyay T, Abiramalatha T, Shaik NB, Pullattayil SAk, Jasani B, Hegde V, Trevisanuto D, Weiner GM
Neonatology. 2022;:1-16
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Editor's Choice
Abstract
INTRODUCTION Placental transfusion strategies in preterm newborns have not been evaluated in low- and middle-income countries (LMICs). The objective of this systematic review was to compare placental transfusion strategies in preterm newborns in LMICs, including delayed cord clamping (DCC) for various time intervals, DCC until cord pulsations stop, umbilical cord milking, and immediate cord clamping (ICC). METHODS Medline, Embase, CINAHL, and CENTRAL were searched from inception. Observational studies and randomized controlled trials (RCTs) were included. Two authors independently extracted data for Bayesian random-effects network meta-analysis (NMA) if more than 3 interventions reported an outcome or a pairwise meta-analysis was utilized. RESULTS Among newborns <34 weeks of gestation, NMA of 9 RCTs could not rule out benefit or harm for survival from DCC 30-60 s compared to ICC: relative risk (RR) (95% credible interval) 0.96 (0.78-1.12), moderate certainty, or any included strategy compared to each other (low to very low certainty). Among late preterm newborns, DCC 120 s might be associated with improved survival: RR (95% confidence interval) 1.11 (1.01-1.22), very low certainty. We could not detect differences in the risk of intraventricular hemorrhage grade > II and bronchopulmonary dysplasia for any included intervention (low to very low certainty). DCC 60 s and 120 s might improve the hematocrit level among all preterm newborns (very low certainty), and DCC 45 s may decrease the risk of receipt of inotropes among newborns <34 weeks of gestation (low certainty). CONCLUSIONS In LMICs, DCC for 60 s and 120 s might improve hematocrit level in preterm newborns, and DCC for 45 s may decrease the risk of receipt of inotropes in newborns <34 weeks, with no conclusive effect on survival.
PICO Summary
Population
Preterm newborns in low- and middle-income countries (9 studies).
Intervention
Delayed cord clamping (DCC) for various time intervals.
Comparison
DCC until cord pulsations stop. Umbilical cord milking. Immediate cord clamping (ICC).
Outcome
Network meta-analysis of 9 randomised controlled trials could not rule out benefit or harm for survival from DCC 30-60s compared to ICC: relative risk (RR), (95% credible interval) 0.96 (0.78 to 1.12), moderate certainty, or any included strategy compared to each other (low to very low certainty). Among late preterm newborns, DCC 120s might be associated with improved survival: RR (95% confidence interval) 1.11 (1.01 to 1.22), very low certainty. Differences were not detected in the risk of intraventricular hemorrhage grade > II and bronchopulmonary dysplasia for any included intervention (low to very low certainty). DCC 60s and 120s might improve the haematocrit level among all preterm newborns (very low certainty), and DCC 45 s may decrease the risk of receipt of inotropes among newborns <34 weeks of gestation (low certainty).
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10.
Postpartum hemorrhage drills or simulations and adverse outcomes: a systematic review and Bayesian meta-analysis
Mendez-Figueroa H, Bell CS, Wagner SM, Pedroza C, Gupta M, Mulder I, Lee K, Blackwell SC, Bartal MF, Chauhan SP
The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians. 2022;:1-12
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Editor's Choice
Abstract
OBJECTIVE To compare the rates of adverse outcomes with postpartum hemorrhage (PPH) before and after implementation of drills or simulation exercises. STUDY ELIGIBILITY CRITERIA We included all English studies that reported on rates of PPH and associated complications during the pre- and post-implementation of interventional exercises. STUDY APPRASIAL AND SYNTHESIS METHODS Two investigators independently reviewed the abstracts, and full articles for eligibility of all studies. Inconsistencies related to study evaluation or data extraction were resolved by a third author. The co-primary outcomes were the rate of PPH and of any transfusion; the secondary outcomes included admission to the intensive care unit (ICU), transfusion ≥ 4 units of packed red blood cells, hysterectomy, or maternal death. Study effects were combined by Bayesian meta-analysis and reported as risk ratios (RR) and 95% credible intervals (Cr). RESULTS We reviewed 142 full length articles. Of these, 18 publications, with 355,060 deliveries-150,562 (42%) deliveries during the pre-intervention and 204,498 (57.6%) deliveries in the post-interventional period-were included in the meta-analysis. Using the Newcastle-Ottawa Scale, only three studies were considered good quality, and none of them were done in the US. The rate of PPH prior to intervention was 5.06% and 5.46% afterwards (RR 1.09, 95% CI 0.87-1.36; probability of reduction in the diagnosis being 21%). The likelihood of transfusion decreased from 1.68% in the pre-intervention to 1.27% in the post-intervention period (RR 0.80, 95% Cr 0.57-1.09). The overall probability of reduction in transfusion was 93%, albeit it varied among studies done in non-US countries (96%) versus in the US (23%). Transfusion of 4 units or more of blood occurred in 0.44% of deliveries before intervention and 0.37% afterwards (RR of 0.85, 95% CI 0.50-1.52), with the overall probability of reduction being 72% (76% probability of reduction in studies from non-US countries and 49% reduction with reports from the US). Surgical interventions to manage PPH, which was not reported in any US studies, occurred in 0.14% before intervention and 0.28% afterwards (RR 1.29; 95% CI 0.56-3.06; probability of reduction 27%). Admission to the ICU occurred in 0.10% before intervention and 0.08% subsequently (RR 0.92, 95% CI 0.58-1.43), with the overall probability of reduction being 65% (81% in studies from non-US countries and 27% from the study done in the US). Maternal death occurred in 0.17% in the pre-intervention period and 0.09% during the post-intervention (RR 0.62, 95% CI 0.33-1.05; probability of reduction 93% in studies from non-US countries and 82% in one study from the US). CONCLUSIONS Interventions to reduce the sequelae of PPH are associated with decrease in adverse outcomes. The conclusion, however, ought not to be accepted reflexively for the US population. All of the studies on the topic done in the US are of poor quality and the associated probability of reduction in sequelae are consistently lower than those done in other countries. SYNOPSIS Since the putative benefits of PPH drills or simulation exercises are based on poor quality pre- and post-intervention trials, policies recommending them ought to be revisited.
PICO Summary
Population
Postpartum haemorrhage patients (PPH), (18 studies with 355,060 deliveries).
Intervention
Systematic review and Bayesian meta-analysis to compare the rates of adverse outcomes with (PPH) before and after implementation of drills or simulation exercises.
Comparison
Outcome
The meta-analysis included 150,562 (42%) deliveries during the pre-intervention and 204,498 (57.6%) deliveries in the post-interventional period. The rate of PPH prior to intervention was 5.06% and 5.46% afterwards (RR 1.09, 95% CI 0.87-1.36; probability of reduction in the diagnosis being 21%). The likelihood of transfusion decreased from 1.68% in the pre-intervention to 1.27% in the post-intervention period (RR 0.80, 95% Cr 0.57-1.09). The overall probability of reduction in transfusion was 93%, albeit it varied among studies done in non-US countries (96%) versus in the US (23%). Transfusion of 4 units or more of blood occurred in 0.44% of deliveries before intervention and 0.37% afterwards (RR of 0.85, 95% CI 0.50-1.52), with the overall probability of reduction being 72% (76% probability of reduction in studies from non-US countries and 49% reduction with reports from the US). Surgical interventions to manage PPH, which was not reported in any US studies, occurred in 0.14% before intervention and 0.28% afterwards (RR 1.29; 95% CI 0.56-3.06; probability of reduction 27%). Admission to the ICU occurred in 0.10% before intervention and 0.08% subsequently (RR 0.92, 95% CI 0.58-1.43), with the overall probability of reduction being 65% (81% in studies from non-US countries and 27% from the study done in the US). Maternal death occurred in 0.17% in the pre-intervention period and 0.09% during the post-intervention (RR 0.62, 95% CI 0.33-1.05; probability of reduction 93% in studies from non-US countries and 82% in one study from the US).