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2.
J Matern Fetal Neonatal Med ; 36(2): 2251076, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37673791

ABSTRACT

OBJECTIVE: To quantify the association between prophylactic radiologic interventions and perioperative blood loss in women with risk factors for placenta accreta spectrum disorder (PAS). METHODS: We conducted a retrospective nationwide cohort study of women with risk factors for placenta accreta spectrum disorder who underwent planned cesarean section in 69 Dutch hospitals between 2008 and 2013. All women had two risk factors for PAS: placenta previa/anterior low-lying placenta and a history of cesarean section(s). Women with and without ultrasonographic signs of PAS were studied as two separate groups. We compared the total blood loss of women with prophylactic radiologic interventions, defined as preoperative placement of balloon catheters or sheaths in the internal iliac or uterine arteries, with that of a control group consisting of women without prophylactic radiologic interventions using multivariable regression. We evaluated maternal morbidity by the number of red blood cell (RBC) units transfused within 24 h following childbirth (categories: 0, 1-3, >4), duration of hospital admission, and need for intensive care unit (ICU) admission. RESULTS: A total of 350 women with placenta previa/anterior low-lying placenta and history of cesarean section(s) were included: 289 with normal ultrasonography, of whom 21 received prophylactic radiologic intervention, and 61 had abnormal ultrasonography, of whom 22 received prophylactic intervention. Among women with normal ultrasonography without prophylactic intervention (n = 268), the median blood loss was 725 mL (interquartile range (IQR) 500-1500) vs. 1000 mL (IQR 550-1750) in women with intervention (n = 21); the adjusted difference in blood loss was 9 mL (95% confidence interval (CI) -315-513), p = .97). Among women with abnormal ultrasonography, those without prophylactic intervention (n = 39) had a median blood loss of 2500 mL (IQR 1200-5000) vs. 1750 mL (IQR 775-4000) in women with intervention (n = 22); the adjusted difference in blood loss was -1141 mL (95% CI -1694- -219, p = .02). Results of outcomes on maternal morbidity were comparable among women with and without prophylactic intervention. CONCLUSION: These findings suggest that prophylactic radiologic interventions prior to planned cesarean section may help to limit perioperative blood loss in women with clear signs of placenta accreta spectrum disorder on ultrasonography, but there was no evidence of a difference within the subgroup without such ultrasonographic signs. The use of these interventions should be discussed in a multidisciplinary shared decision-making process, including discussions of potential benefits and possible complications. TRIAL REGISTRATION: Netherlands Trial Registry, https://onderzoekmetmensen.nl/en/trial/28238, identifier NL4210 (NTR4363).


Subject(s)
Placenta Accreta , Placenta Previa , Postpartum Hemorrhage , Pregnancy , Female , Humans , Postpartum Hemorrhage/etiology , Postpartum Hemorrhage/prevention & control , Cesarean Section/adverse effects , Blood Loss, Surgical/prevention & control , Cohort Studies , Placenta Accreta/diagnostic imaging , Placenta Accreta/prevention & control , Retrospective Studies
3.
BJOG ; 130(12): 1493-1501, 2023 11.
Article in English | MEDLINE | ID: mdl-37113103

ABSTRACT

OBJECTIVE: Analysis of atypical cases of uterine rupture, namely, uterine rupture occurring in unscarred, preterm or prelabour uteri. DESIGN: Descriptive multi-country population-based study. SETTING: Ten high-income countries within the International Network of Obstetric Survey Systems. POPULATION: Women with unscarred, preterm or prelabour ruptured uteri. METHODS: We merged prospectively collected individual patient data in ten population-based studies of women with complete uterine rupture. In this analysis, we focused on women with uterine rupture of unscarred, preterm or prelabour ruptured uteri. MAIN OUTCOME MEASURES: Incidence, women's characteristics, presentation and maternal and perinatal outcome. RESULTS: We identified 357 atypical uterine ruptures in 3 064 923 women giving birth. Estimated incidence was 0.2 per 10 000 women (95% CI 0.2-0.3) in the unscarred uteri, 0.5 (95% CI 0.5-0.6) in the preterm uteri, 0.7 (95% CI 0.6-0.8) in the prelabour uteri, and 0.5 (95% CI 0.4-0.5) in the group with no previous caesarean. Atypical uterine rupture resulted in peripartum hysterectomy in 66 women (18.5%, 95% CI 14.3-23.5%), three maternal deaths (0.84%, 95% CI 0.17-2.5%) and perinatal death in 62 infants (19.7%, 95% CI 15.1-25.3%). CONCLUSIONS: Uterine rupture in preterm, prelabour or unscarred uteri are extremely uncommon but were associated with severe maternal and perinatal outcome. We found a mix of risk factors in unscarred uteri, most preterm uterine ruptures occurred in caesarean-scarred uteri and most prelabour uterine ruptures in 'otherwise' scarred uteri. This study may increase awareness among clinicians and raise suspicion of the possibility of uterine rupture under these less expected conditions.


Subject(s)
Perinatal Death , Uterine Rupture , Infant, Newborn , Infant , Pregnancy , Female , Humans , Uterine Rupture/epidemiology , Uterine Rupture/etiology , Uterine Rupture/surgery , Incidence , Uterus/surgery , Hysterectomy , Pregnancy Outcome/epidemiology
4.
Health Sci Rep ; 5(5): e664, 2022 Sep.
Article in English | MEDLINE | ID: mdl-35949672

ABSTRACT

Background and Aims: To analyze outcomes of nationwide local audits of uterine rupture to draw lessons for clinical care. Methods: Descriptive cohort study. Critical incident audit sessions within all local perinatal cooperation groups in the Netherlands. Women who sustained uterine rupture between January 1st, 2017 and December 31st, 2019. Main Outcome Measures: Improvable factors, recommendations, and lessons learned for clinical care. Women's case histories were discussed in multidisciplinary perinatal audit sessions. Participants evaluated care against national and local clinical guidelines and common professional standards to identify improvable factors. Cases and outcomes were registered in a nationwide database. Results: One hundred and fourteen women who sustained uterine rupture were discussed in local perinatal audit sessions by 40-60 participants on average: A total of 111 (97%) were multiparous of whom 107 (94%) had given birth by cesarean section in a previous pregnancy. The audit revealed 178 improvable factors and 200 recommendations. Six percent (N = 11) of the improvable factors were identified as very likely and 18% (N = 32) as likely to have a relationship with the outcome or occurrence of uterine rupture. Improvable factors were related to inadequate communication, absent, or unclear documentation, delay in diagnosing the rupture, and suboptimal management of labor. Speak up in case a suspicion arises, escalating care by involving specialist obstetricians, addressing the importance of accurate documentation, and improving training related to fetal monitoring were the most frequent recommendations and should be topics for team (skills and drills) training. Conclusions: Through a nationwide incident audit of uterine rupture, we identified improvable factors related to communication, documentation, and organization of care. Lessons learned include "speaking up," improving the transfer of information and team training are crucial to reduce the incidence of uterine rupture.

5.
Acta Obstet Gynecol Scand ; 101(4): 450-460, 2022 Apr.
Article in English | MEDLINE | ID: mdl-35238018

ABSTRACT

INTRODUCTION: Obstetric hemorrhage-related deaths are rare in high income countries. Yet, with increasing incidences of obstetric hemorrhage in these countries, it is of utmost importance to learn lessons from each obstetric hemorrhage-related death to improve maternity care. Our objective was to calculate the obstetric hemorrhage-related maternal mortality ratio (MMR), assess causes of obstetric hemorrhage-related deaths, and identify lessons learned. MATERIAL AND METHODS: Nationwide mixed-methods prospective case-series with confidential enquiries into maternal deaths due to obstetric hemorrhage in the Netherlands from January 1, 2006 to December 31, 2019. RESULTS: The obstetric hemorrhage-related MMR in the Netherlands in 2006-2019 was 0.7 per 100 000 livebirths and was not statistically significantly different compared with the previous MMR of 1.0 per 100 000 livebirths in 1993-2005 (odds ratio 0.70, 95% confidence interval 0.38-1.30). Leading underlying cause of hemorrhage was retained placenta. Early recognition of persistent bleeding, prompt involvement of a senior clinician and timely management tailored to the cause of hemorrhage with attention to coagulopathy were prominent lessons learned. Also, timely recourse to surgical interventions, including hysterectomy, in case other management options fail to stop bleeding came up as an important lesson in several obstetric hemorrhage-related deaths. CONCLUSIONS: The obstetric hemorrhage-related MMR in the Netherlands in 2006-2019 has not substantially changed compared to the MMR of the previous enquiry in 1993-2005. Although obstetric hemorrhage is commonly encountered by maternity care professionals, it is important to remain vigilant for possible adverse maternal outcomes and act upon an ongoing bleeding following birth in a more timely and adequate manner. Our confidential enquiries still led to important lessons learned with clinical advice to professionals as how to improve maternity care and avoid maternal deaths. Drawing lessons from maternal deaths should remain a qualitative and moral imperative.


Subject(s)
Maternal Death , Maternal Health Services , Obstetrics , Female , Hemorrhage , Humans , Maternal Death/etiology , Netherlands/epidemiology , Pregnancy
6.
Acta Obstet Gynecol Scand ; 101(4): 441-449, 2022 04.
Article in English | MEDLINE | ID: mdl-35352820

ABSTRACT

INTRODUCTION: To calculate the maternal mortality ratio (MMR) for 2006-2018 in the Netherlands and compare this with 1993-2005, and to describe women's characteristics, causes of death and improvable factors. MATERIAL AND METHODS: We performed a nationwide, cohort study of all maternal deaths between January 1, 2006 and December 31, 2018 reported to the Audit Committee Maternal Mortality and Morbidity. Main outcome measures were the national MMR and causes of death. RESULTS: Overall MMR was 6.2 per 100 000 live births, a decrease from 12.1 in 1993-2005 (risk ratio [RR] 0.5). Women with a non-western ethnic background had an increased MMR compared with Dutch women (MMR 6.5 vs. 5.0, RR 1.3). The MMR was increased among women with a background from Surinam/Dutch Antilles (MMR 14.7, RR 2.9). Half of all women had an uncomplicated medical history (79/161, 49.1%). Of 171 pregnancy-related deaths within 1 year postpartum, 102 (60%) had a direct and 69 (40%) an indirect cause of death. Leading causes within 42 days postpartum were cardiac disease (n = 21, 14.9%), hypertensive disorders (n = 20, 14.2%) and thrombosis (n = 19, 13.5%). Up to 1 year postpartum, the most common cause of death was cardiac disease (n = 32, 18.7%). Improvable care factors were identified in 76 (47.5%) of all deaths. CONCLUSIONS: Maternal mortality halved in 2006-2018 compared with 1993-2005. Cardiac disease became the main cause. In almost half of all deaths, improvable factors were identified and women with a background from Surinam/Dutch Antilles had a threefold increased risk of death compared with Dutch women without a background of migration.


Subject(s)
Maternal Death , Pregnancy Complications , Cause of Death , Cohort Studies , Female , Humans , Netherlands/epidemiology , Pregnancy , Pregnancy Complications/etiology
7.
PLoS Med ; 19(2): e1003892, 2022 02.
Article in English | MEDLINE | ID: mdl-35104279

ABSTRACT

BACKGROUND: Preterm birth is the leading cause of neonatal morbidity and mortality. The recurrence rate of spontaneous preterm birth is high, and additional preventive measures are required. Our objective was to assess the effectiveness of low-dose aspirin compared to placebo in the prevention of preterm birth in women with a previous spontaneous preterm birth. METHODS AND FINDINGS: We performed a parallel multicentre, randomised, double-blinded, placebo-controlled trial (the APRIL study). The study was performed in 8 tertiary and 26 secondary care hospitals in the Netherlands. We included women with a singleton pregnancy and a history of spontaneous preterm birth of a singleton between 22 and 37 weeks. Participants were randomly assigned to aspirin 80 mg daily or placebo initiated between 8 and 16 weeks of gestation and continued until 36 weeks or delivery. Randomisation was computer generated, with allocation concealment by using sequentially numbered medication containers. Participants, their healthcare providers, and researchers were blinded for treatment allocation. The primary outcome was preterm birth <37 weeks of gestation. Secondary outcomes included a composite of poor neonatal outcome (bronchopulmonary dysplasia, periventricular leukomalacia > grade 1, intraventricular hemorrhage > grade 2, necrotising enterocolitis > stage 1, retinopathy of prematurity, culture proven sepsis, or perinatal death). Analyses were performed by intention to treat. From May 31, 2016 to June 13, 2019, 406 women were randomised to aspirin (n = 204) or placebo (n = 202). A total of 387 women (81.1% of white ethnic origin, mean age 32.5 ± SD 3.8) were included in the final analysis: 194 women were allocated to aspirin and 193 to placebo. Preterm birth <37 weeks occurred in 41 (21.2%) women in the aspirin group and 49 (25.4%) in the placebo group (relative risk (RR) 0.83, 95% confidence interval (CI) 0.58 to 1.20, p = 0.32). In women with ≥80% medication adherence, preterm birth occurred in 24 (19.2%) versus 30 (24.8%) women (RR 0.77, 95% CI 0.48 to 1.25, p = 0.29). The rate of the composite of poor neonatal outcome was 4.6% (n = 9) versus 2.6% (n = 5) (RR 1.79, 95% CI 0.61 to 5.25, p = 0.29). Among all randomised women, serious adverse events occurred in 11 out of 204 (5.4%) women allocated to aspirin and 11 out of 202 (5.4%) women allocated to placebo. None of these serious adverse events was considered to be associated with treatment allocation. The main study limitation is the underpowered sample size due to the lower than expected preterm birth rates. CONCLUSIONS: In this study, we observed that low-dose aspirin did not significantly reduce the preterm birth rate in women with a previous spontaneous preterm birth. However, a modest reduction of preterm birth with aspirin cannot be ruled out. Further research is required to determine a possible beneficial effect of low-dose aspirin for women with a previous spontaneous preterm birth. TRIAL REGISTRATION: Dutch Trial Register (NL5553, NTR5675) https://www.trialregister.nl/trial/5553.


Subject(s)
Aspirin/administration & dosage , Obstetric Labor, Premature/prevention & control , Adult , Dose-Response Relationship, Drug , Double-Blind Method , Female , Humans , Netherlands , Pregnancy , Premature Birth/prevention & control
8.
Article in English | MEDLINE | ID: mdl-33322495

ABSTRACT

With postpartum hemorrhage (PPH) continuing to be the leading cause of maternal mortality in most low-resource settings, an audit of the quality of care in health facilities is essential. The purpose of this study was to identify areas of substandard care and establish recommendations for the management of PPH in Hiwot Fana Specialized University Hospital, eastern Ethiopia. Using standard criteria (n = 8) adapted to the local hospital setting, we audited 45 women with PPH admitted from August 2018 to March 2019. Four criteria were agreed as being low: IV line-setup (32 women, 71.1%), accurate postpartum vital sign monitoring (23 women, 51.1%), performing typing and cross-matching (22 women, 48.9%), and fluid intake/output chart maintenance (6 women, 13.3%). In only 3 out of 45 women (6.7%), all eight standard criteria were met. Deficiencies in the case of note documentation and clinical monitoring, non-availability of medical resources and blood for transfusion, as well as delays in clinical management were identified. The audit created awareness, resulting in self-reflection of current practice and promoted a sense of responsibility to improve care among hospital staff. Locally appropriate recommendations and an intervention plan based on available resources were formulated.


Subject(s)
Clinical Audit , Postpartum Hemorrhage/therapy , Ethiopia , Female , Hospitals, University , Humans , Maternal Mortality , Pregnancy
9.
J Glob Health ; 10(1): 01041310, 2020 Jun.
Article in English | MEDLINE | ID: mdl-32373341

ABSTRACT

BACKGROUND: Although maternal near miss (MNM) is often considered a 'great save' because the woman survived life-threatening complications, these complications may have resulted in loss of a child or severe neonatal morbidity. The objective of this study was to assess proportion of perinatal mortality (stillbirths and early neonatal deaths) in a cohort of women with MNM in eastern Ethiopia. In addition, we compared perinatal outcomes among women who fulfilled the World Health Organization (WHO) and the sub-Saharan African (SSA) MNM criteria. METHODS: In a prospective cohort design, women with potentially life-threatening conditions (PLTC) (severe postpartum hemorrhage, severe pre-(eclampsia), sepsis/severe systemic infection, and ruptured uterus) were identified every day from January 1st, 2016, to April 30th, 2017, and followed until discharge in the two main hospitals in Harar, Ethiopia. Maternal and perinatal outcomes were collected using both sets of criteria. Numbers and proportions of stillbirths and early neonatal deaths were computed and compared. RESULTS: Of 1054 women admitted with PTLC during the study period, 594 women fulfilled any of the MNM criteria. After excluding near misses related to abortion, ectopic pregnancy or among undelivered women, 465 women were included, in whom 149 (32%) perinatal deaths occurred: 132 (88.6%) stillbirths and 17 (11.4%) early neonatal deaths. In absolute numbers, the SSA criteria picked up more perinatal deaths compared to the WHO criteria, but the proportion of perinatal deaths was lower in SSA group compared to the WHO (149/465, 32% vs 62/100, 62%). Perinatal mortality was more likely among near misses with antepartum hemorrhage (adjusted odds ratio (aOR) = 4.81; 95% CI = 1.76-13.20), grand multiparous women (aOR = 4.31; 95% confidence interval CI = 1.23-15.25), and women fulfilling any of the WHO near miss criteria (aOR = 4.89; 95% CI = 2.17-10.99). CONCLUSION: WHO MNM criteria pick up fewer perinatal deaths, although perinatal mortality occurred in a larger proportion of women fulfilling the WHO MNM criteria compared to the SSA MNM criteria. As women with MNM have increased risk of perinatal deaths (in both definitions), a holistic care addressing the needs of the mother and baby should be considered in management of women with MNM.


Subject(s)
Mothers/statistics & numerical data , Near Miss, Healthcare , Perinatal Death , Stillbirth/epidemiology , Adult , Ethiopia , Female , Humans , Infant , Infant, Newborn , Maternal Death , Postpartum Hemorrhage , Pregnancy , Pregnancy Complications/mortality , Prenatal Care , Prospective Studies
11.
Int J Womens Health ; 12: 255-263, 2020.
Article in English | MEDLINE | ID: mdl-32308499

ABSTRACT

OBJECTIVES: To assess life-threatening complications among women admitted with severe hypertensive disorders of pregnancy and compare applicability of World Health Organization (WHO) maternal near-miss (MNM) criteria and the recently adapted sub-Saharan African (SSA) MNM criteria in eastern Ethiopia. METHODS: Of 1,054 women admitted with potentially life-threatening conditions between January 2016 and April 2017, 562 (53.3%) had severe preeclampsia/eclampsia. We applied the definition of MNM according to the WHO MNM criteria and the SSA MNM criteria. Logistic regression was performed to identify factors associated with severe maternal outcomes (MNMs and maternal deaths). RESULTS: The SSA MNM criteria identified 285 cases of severe maternal outcomes: 271 MNMs and 14 maternal deaths (mortality index 4.9%). The WHO criteria identified 50 cases of severe maternal outcomes: 36 MNMs and 14 maternal deaths (mortality index 28%). The MNM ratio was 36.6 per 1,000 livebirths according to the SSA MNM criteria and 4.9 according to the WHO criteria. More than 80% of women in both groups had MNM events on arrival or within 12 hours after admission. Women without antenatal care, from rural areas, referred from other facilities, and with concomitant hemorrhage more often developed severe maternal outcomes. CONCLUSION: Regarding hypertensive disorders of pregnancy, the SSA tool is more inclusive than the WHO tool, while still maintaining a considerably high mortality index indicating severity of included cases. This may enable more robust audits. Strengthening the referral system and improving prevention and management of obstetric hemorrhage in women with hypertensive disorders of pregnancy are required to avert severe maternal outcomes.

12.
JAMA Netw Open ; 2(11): e1915628, 2019 11 01.
Article in English | MEDLINE | ID: mdl-31730187

ABSTRACT

Importance: Early plasma transfusion for women with severe postpartum hemorrhage (PPH) is recommended to prevent coagulopathy. However, there is no comparative, quantitative evidence on the association of early plasma transfusion with maternal outcomes. Objective: To compare the incidence of adverse maternal outcomes among women who received plasma during the first 60 minutes of persistent PPH vs women who did not receive plasma for similarly severe persistent PPH. Design, Setting, and Participants: This multicenter cohort study used a consecutive sample of women with persistent PPH, defined as PPH refractory to first-line measures to control bleeding, between January 1, 2011, and January 1, 2013. Time-dependent propensity score matching was used to select women who received plasma during the first 60 minutes of persistent PPH and match each of them with a woman who had shown the same severity and received the same treatment of PPH but who had not received plasma at the moment of matching. Transfusions were not guided by coagulation tests. Statistical analysis was performed from June 2018 to June 2019. Exposures: Transfusion of plasma during the first 60 minutes of persistent PPH vs no or later plasma transfusion. Main Outcomes and Measures: Incidence of adverse maternal outcomes, defined as a composite of death, hysterectomy, or arterial embolization. Results: This study included 1216 women (mean [SD] age, 31.6 [5.0] years) with persistent PPH, of whom 932 (76.6%) delivered vaginally and 780 (64.1%) had PPH caused by uterine atony. Seven women (0.6%) died because of PPH, 62 women (5.1%) had a hysterectomy, and 159 women (13.1%) had arterial embolizations. Among women who received plasma during the first 60 minutes of persistent PPH, 114 women could be matched with a comparable woman who had not received plasma at the moment of matching. The incidence of adverse maternal outcomes was similar between the women, with adverse outcomes recorded in 24 women (21.2%) who received early plasma transfusion and 23 women (19.9%) who did not receive early plasma transfusion (odds ratio, 1.09; 95% CI, 0.57-2.09). Results of sensitivity analyses were comparable to the primary results. Conclusions and Relevance: In this cohort study, initiation of plasma transfusion during the first 60 minutes of persistent PPH was not associated with adverse maternal outcomes compared with no or later plasma transfusion, independent of severity of PPH.


Subject(s)
Blood Component Transfusion , Plasma , Postpartum Hemorrhage/therapy , Puerperal Disorders/epidemiology , Time-to-Treatment , Adult , Cohort Studies , Female , Humans , Incidence
13.
BMC Pregnancy Childbirth ; 19(1): 361, 2019 Oct 17.
Article in English | MEDLINE | ID: mdl-31623631

ABSTRACT

BACKGROUND: The absence of a uniform and clinically relevant definition of severe postpartum haemorrhage hampers comparative studies and optimization of clinical management. The concept of persistent postpartum haemorrhage, based on refractoriness to initial first-line treatment, was proposed as an alternative to common definitions that are either based on estimations of blood loss or transfused units of packed red blood cells (RBC). We compared characteristics and outcomes of women with severe postpartum haemorrhage captured by these three types of definitions. METHODS: In this large retrospective cohort study in 61 hospitals in the Netherlands we included 1391 consecutive women with postpartum haemorrhage who received either ≥4 units of RBC or a multicomponent transfusion. Clinical characteristics and outcomes of women with severe postpartum haemorrhage defined as persistent postpartum haemorrhage were compared to definitions based on estimated blood loss or transfused units of RBC within 24 h following birth. Adverse maternal outcome was a composite of maternal mortality, hysterectomy, arterial embolisation and intensive care unit admission. RESULTS: One thousand two hundred sixty out of 1391 women (90.6%) with postpartum haemorrhage fulfilled the definition of persistent postpartum haemorrhage. The majority, 820/1260 (65.1%), fulfilled this definition within 1 h following birth, compared to 819/1391 (58.7%) applying the definition of ≥1 L blood loss and 37/845 (4.4%) applying the definition of ≥4 units of RBC. The definition persistent postpartum haemorrhage captured 430/471 adverse maternal outcomes (91.3%), compared to 471/471 (100%) for ≥1 L blood loss and 383/471 (81.3%) for ≥4 units of RBC. Persistent postpartum haemorrhage did not capture all adverse outcomes because of missing data on timing of initial, first-line treatment. CONCLUSION: The definition persistent postpartum haemorrhage identified women with severe postpartum haemorrhage at an early stage of haemorrhage, unlike definitions based on blood transfusion. It also captured a large majority of adverse maternal outcomes, almost as large as the definition of ≥1 L blood loss, which is commonly applied as a definition of postpartum haemorrhage rather than severe haemorrhage.


Subject(s)
Blood Transfusion/methods , Postpartum Hemorrhage/therapy , Adult , Embolization, Therapeutic/methods , Female , Follow-Up Studies , Humans , Hysterectomy/methods , Incidence , Infant, Newborn , Male , Netherlands/epidemiology , Postpartum Hemorrhage/diagnosis , Postpartum Hemorrhage/epidemiology , Pregnancy , Prognosis , Retrospective Studies , Risk Factors , Severity of Illness Index , Survival Rate/trends
14.
BMJ Open ; 9(8): e029808, 2019 08 18.
Article in English | MEDLINE | ID: mdl-31427334

ABSTRACT

INTRODUCTION: In women with gestational diabetes mellitus (GDM) requiring pharmacotherapy, insulin was the established first-line treatment. More recently, oral glucose lowering drugs (OGLDs) have gained popularity as a patient-friendly, less expensive and safe alternative. Monotherapy with metformin or glibenclamide (glyburide) is incorporated in several international guidelines. In women who do not reach sufficient glucose control with OGLD monotherapy, usually insulin is added, either with or without continuation of OGLDs. No reliable data from clinical trials, however, are available on the effectiveness of a treatment strategy using all three agents, metformin, glibenclamide and insulin, in a stepwise approach, compared with insulin-only therapy for improving pregnancy outcomes. In this trial, we aim to assess the clinical effectiveness, cost-effectiveness and patient experience of a stepwise combined OGLD treatment protocol, compared with conventional insulin-based therapy for GDM. METHODS: The SUGAR-DIP trial is an open-label, multicentre randomised controlled non-inferiority trial. Participants are women with GDM who do not reach target glycaemic control with modification of diet, between 16 and 34 weeks of gestation. Participants will be randomised to either treatment with OGLDs, starting with metformin and supplemented as needed with glibenclamide, or randomised to treatment with insulin. In women who do not reach target glycaemic control with combined metformin and glibenclamide, glibenclamide will be substituted with insulin, while continuing metformin. The primary outcome will be the incidence of large-for-gestational-age infants (birth weight >90th percentile). Secondary outcome measures are maternal diabetes-related endpoints, obstetric complications, neonatal complications and cost-effectiveness analysis. Outcomes will be analysed according to the intention-to-treat principle. ETHICS AND DISSEMINATION: The study protocol was approved by the Ethics Committee of the Utrecht University Medical Centre. Approval by the boards of management for all participating hospitals will be obtained. Trial results will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NTR6134; Pre-results.


Subject(s)
Diabetes, Gestational/drug therapy , Glyburide/therapeutic use , Hypoglycemic Agents/therapeutic use , Metformin/therapeutic use , Administration, Oral , Blood Glucose/drug effects , Cost-Benefit Analysis , Diabetes, Gestational/blood , Drug Therapy, Combination , Equivalence Trials as Topic , Female , Gestational Age , Humans , Insulin/therapeutic use , Multicenter Studies as Topic , Pregnancy , Pregnancy Outcome
15.
Eur J Obstet Gynecol Reprod Biol ; 237: 145-150, 2019 Jun.
Article in English | MEDLINE | ID: mdl-31051417

ABSTRACT

BACKGROUND: Maternal cardiac arrest is a complex and demanding clinical situation requiring a well-attuned team effort of healthcare workers of multiple disciplines. A recent report on maternal cardiac arrest in the United Kingdom reported a rise in incidence over a span of 10 years, while maternal mortality increased in the United States between 2000 and 2014. However, reported causes of maternal cardiac arrest differed between both countries. OBJECTIVE(S): To determine the incidence, causes and management of maternal cardiac arrest in the Netherlands and compare incidence with previous estimates in the Netherlands and the United Kingdom. STUDY DESIGN: Using the Netherlands Obstetric Surveillance System, all Dutch cases of maternal cardiac arrest during a three-year period (2013-2016) were prospectively collected. Complete casefile copies were obtained for analysis. Main outcome measures were incidence of maternal cardiac arrest and cardiac arrest in pregnancy, use of perimortem caesarean section if appropriate and maternal death. RESULTS: The monthly card return rate was 97%; 18 women with cardiac arrest during pregnancy and 20 postpartum met the inclusion criteria. Incidence of maternal cardiac arrest was 7.6 per 100,000 pregnancies and 3.6 per 100,000 pregnancies excluding postpartum maternal cardiac arrest. Main causes were pulmonary embolism (n = 9), major obstetric hemorrhage (n = 7) and amniotic fluid embolism (n = 6). Aortocaval compression relief and perimortem caesarean section were performed in 9/14 (29%) and 11/14 (79%) respectively in pregnancies 20 weeks gestational age onwards. Twenty-two women died, representing a case fatality rate of 58% (95% CI 42-72%). CONCLUSION(S): There is a higher incidence of cardiac arrest in pregnancy compared to both previous estimates in the Netherlands and recently established figures in the United Kingdom. Main causes of maternal cardiac arrest are potentially preventable and/or treatable complications of pregnancy. Insufficient use of critical elements of obstetric resuscitation identifies the need for enhanced obstetric emergency training for obstetric and non-obstetric first responders.


Subject(s)
Heart Arrest/epidemiology , Pregnancy Complications, Cardiovascular/epidemiology , Adult , Female , Humans , Incidence , Maternal Mortality , Netherlands/epidemiology , Pregnancy , Risk Factors
16.
Hypertens Pregnancy ; 38(2): 78-88, 2019 May.
Article in English | MEDLINE | ID: mdl-30892981

ABSTRACT

OBJECTIVE: To perform an external validation of all published prognostic models for first-trimester prediction of the risk of developing preeclampsia (PE). METHODS: Women <14 weeks of pregnancy were recruited in the Netherlands. All systematically identified prognostic models for PE that contained predictors commonly available were eligible for external validation. RESULTS: 3,736 women were included; 87 (2.3%) developed PE. Calibration was poor due to overestimation. Discrimination of 9 models for LO-PE ranged from 0.58 to 0.71 and of 9 models for all PE from 0.55 to 0.75. CONCLUSION: Only a few easily applicable prognostic models for all PE showed discrimination above 0.70, which is considered an acceptable performance.


Subject(s)
Models, Theoretical , Pre-Eclampsia/diagnosis , Adult , Female , Humans , Pregnancy , Prognosis , Prospective Studies , Risk Assessment
17.
BMC Pregnancy Childbirth ; 19(1): 79, 2019 Feb 26.
Article in English | MEDLINE | ID: mdl-30808325

ABSTRACT

BACKGROUND: Applicability of the World Health Organization (WHO) maternal near miss criteria in low-income settings is not systematically addressed in the literature. The objective of this review was to determine the applicability of the WHO maternal near miss tool in sub-Saharan Africa. METHODS: We searched PubMed, Embase, Popline, CINAHL, AJOL, and Google scholar using key words for maternal near miss and sub-Saharan Africa. Studies which applied the WHO maternal near miss criteria, containing clear definitions, and published between January 1st, 2009 and December 31st, 2017 were included. Two authors independently extracted data. Quantitative analysis and narrative synthesis were conducted, and medians with interquartile range (IQR) were calculated for summarizing the findings. Methodological quality of the studies was assessed using the Estabrook's quality assessment and validity tool. RESULTS: Fifteen studies from nine countries comprising 227,077 participants were included. Median maternal near miss ratio was 24.2 (IQR: 12.4-35.8) per 1000 live births ranging from 4.4 in a population-based study in South Africa to 198 in a rural private hospital in Nigeria. Eight studies reported challenges in implementing the WHO maternal near miss tool, especially related to the threshold for blood transfusion, and availability of several laboratory-based criteria. In three studies, local adaptations were made. CONCLUSION: This review showed that the WHO maternal near miss tool is not uniformly applied in sub-Saharan Africa. Therefore, a common adaptation for the region is required to increase its applicability.


Subject(s)
Maternal Health Services/statistics & numerical data , Maternal Mortality , Near Miss, Healthcare/standards , Pregnancy Complications/mortality , Quality Assurance, Health Care/standards , Africa South of the Sahara , Female , Humans , Near Miss, Healthcare/methods , Pregnancy , Quality Assurance, Health Care/methods , World Health Organization
18.
Eur J Obstet Gynecol Reprod Biol ; 235: 49-56, 2019 Apr.
Article in English | MEDLINE | ID: mdl-30784827

ABSTRACT

OBJECTIVE: To determine the association between increasing volumes of crystalloids and colloids administered before transfusion of packed red blood cells in women with persistent postpartum haemorrhage and adverse maternal outcomes. STUDY DESIGN: Retrospective cohort study in the Netherlands. Women with persistent postpartum haemorrhage and known clear fluids volume for resuscitation were included. Women who received ≤2 L of clear fluids were the reference group. We determined the effect of every additional litre of clear fluids on total blood loss, severe maternal morbidity and mortality. Results were adjusted for patient and bleeding characteristics. RESULTS: Of the 883 included women, 199 received ≤2 L of clear fluids. Median blood loss for the reference group was 2.9 L (interquartile range 2.2-3.4). Adjusted mean difference in blood loss compared with the reference group was 0.2 L (95% confidence interval -0.1 to 0.5) for women in the >2 to ≤3 L, 0.4 L (0.1-0.7) for the >3 to ≤4 L category, 0.6 L (0.5-0.7) for the >4 to ≤5 L category, and 1.9 L (1.5-2.3) for the >5 to ≤7 L category. Adjusted odds ratios for adverse maternal outcomes were 1.0 (0.7-1.6), 1.2 (0.8-1.9), 1.8 (1.1-3.1) and 4.4 (2.6-7.5) for women in the 2 to ≤3 L category, >3 to ≤4 L, >4 to ≤5 L, and >5 to ≤7 L volume categories respectively. Results were similar in strata of different severities of bleeding. CONCLUSION: Clear fluids volume >4 L was independently associated with adverse maternal outcome in women with persistent postpartum haemorrhage.


Subject(s)
Fluid Therapy/adverse effects , Postpartum Hemorrhage/therapy , Adult , Blood Transfusion/methods , Colloids/administration & dosage , Crystalloid Solutions/administration & dosage , Female , Fluid Therapy/methods , Humans , Netherlands , Pregnancy , Retrospective Studies , Treatment Outcome
19.
Acta Obstet Gynecol Scand ; 98(6): 795-804, 2019 06.
Article in English | MEDLINE | ID: mdl-30667050

ABSTRACT

INTRODUCTION: Incidence of massive transfusion after birth was high in the Netherlands between 2004 and 2006 compared with other high-income countries. This study investigated incidence, causes, management and outcome of women receiving massive transfusion due to postpartum hemorrhage in the Netherlands in more recent years. MATERIAL AND METHODS: Data for all pregnant women who received eight or more units of packed red blood cells from a gestational age of 20 weeks and within the first 24 hours after childbirth, during 2011 and 2012, were obtained from a nationwide retrospective cohort study, including 61 hospitals with a maternity unit in the Netherlands. RESULTS: Incidence of massive transfusion due to postpartum hemorrhage decreased to 65 per 100 000 births (95% CI 56-75) between 2011 and 2012, from 91 per 100 000 births (95% CI 81-101) between 2004 and 2006, while median blood loss increased from 4500 mL (interquartile range 3250-6000) to 6000 mL (interquartile range 4500-8000). Uterine atony remained the leading cause of hemorrhage. Thirty percent (53/176) underwent peripartum hysterectomy between 2011 and 2012, compared with 25% (83/327) between 2004 and 2006. Case fatality rate for women who received massive transfusion due to postpartum hemorrhage was 2.3% (4/176) between 2011 and 2012, compared with 0.9% (3/327) between 2004 and 2006. CONCLUSIONS: The incidence of postpartum hemorrhage with massive transfusion decreased in the Netherlands between both time frames, but remained an important cause of maternal mortality and morbidity, including peripartum hysterectomy. National surveillance of maternal morbidity and mortality due to postpartum hemorrhage through an improved and continuous registration with confidential enquiries may lead to the identification of clear improvements of maternal care.


Subject(s)
Blood Transfusion , Blood Volume , Hysterectomy , Postpartum Hemorrhage , Prenatal Care/standards , Uterine Inertia/epidemiology , Adult , Blood Transfusion/methods , Blood Transfusion/statistics & numerical data , Female , Humans , Hysterectomy/methods , Hysterectomy/statistics & numerical data , Incidence , Mortality/trends , Netherlands/epidemiology , Postpartum Hemorrhage/epidemiology , Postpartum Hemorrhage/etiology , Postpartum Hemorrhage/therapy , Pregnancy , Quality Improvement/organization & administration , Retrospective Studies
20.
Acta Obstet Gynecol Scand ; 98(3): 342-350, 2019 03.
Article in English | MEDLINE | ID: mdl-30346039

ABSTRACT

INTRODUCTION: There have been many efforts in the last decade to decrease the incidence of eclampsia and its related complications in the Netherlands, such as lowering thresholds for treatment of hypertension and mandatory professional training. To determine the impact of these policy changes on incidence and outcomes, we performed a nationwide registration of eclampsia, 10 years after the previous registration. MATERIAL AND METHODS: Cases of eclampsia were prospectively collected using the Netherlands Obstetric Surveillance System (NethOSS; 2013-2016) in all hospitals with a maternity unit in the Netherlands. Complete case file copies were obtained for comparative analysis of individual level data with the previous cohort (2004-2006). Primary outcome measure was incidence of eclampsia; main secondary outcomes were antihypertensive and magnesium sulfate use, and maternal and perinatal mortality. RESULTS: NethOSS identified 88 women with eclampsia. The incidence decreased from 6.2/10 000 in 2004-2006 to 1.8/10 000 births (relative risk [RR] 0.28, 95% confidence interval [CI] 0.22-0.36). Increases in the use of antihypertensive medication (61/82 vs 35/216; RR 18.4, 95% CI 9.74-34.70) and magnesium sulfate treatment (82/82 vs 201/216; RR 1.08, 95% CI 1.04-1.12) were observed. There was one intrauterine death following termination of pregnancy. No cases of neonatal mortality were reported in NethOSS compared with 11 in the LEMMoN. Maternal death occurred in one woman compared vs three in the previous registration. CONCLUSIONS: There has been a strong reduction of eclampsia and associated perinatal mortality in the Netherlands over the last decade. Management changes and increased awareness may have contributed to this reduction.


Subject(s)
Delivery, Obstetric/statistics & numerical data , Eclampsia/epidemiology , Adult , Antihypertensive Agents/therapeutic use , Eclampsia/therapy , Female , Humans , Incidence , Infant, Newborn , Magnesium Sulfate/therapeutic use , Monitoring, Physiologic , Netherlands/epidemiology , Perinatal Mortality , Pre-Eclampsia/epidemiology , Pregnancy , Young Adult
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