Pregnant women's willingness to participate in a randomized trial comparing induction of labor at 39 weeks versus expectant management: A survey in the Netherlands

IntroductionA randomized controlled trial (RCT) in the United States, the ARRIVE trial, has indicated that induction of labor (IOL) in low-risk nulliparous women with a gestational age (GA) of 39 weeks compared to expectant management (EM) resulted in a significant lower rate of cesarean deliveries. The Dutch maternity care system is different compared to the United States with, among other factors, an overall significantly lower percentage of caesarean sections (CS). To investigate whether IOL has a favorable outcome in the Dutch maternity care system, a new trial is advised. In this questionnaire-based study we aim to evaluate whether Dutch low-risk pregnant women would be willing to participate in an RCT comparing IOL at 39 weeks to EM. Materials and methodsWe conducted an online survey in 2020 in the Netherlands. Respondent recruitment took place both in outpatient clinics at hospitals and midwife practices and via social media. Inclusion criteria were pregnant women with singleton gestation, GA ≤ 39 weeks, age 18 years or older and residency in the Netherlands. Exclusion criteria were multiple gestation, a history of a CS, planned IOL or CS in current pregnancy and GA > 39 weeks. A subgroup was formed of low risk (receiving primary care) nulliparous women with a gestational age between 34 and 39 weeks, comparable with the ARRIVE trial. ResultsThree hundred eighty respondents participated. Of all respondents (nulli- and multiparous), 47 (12.4%) would be willing to participate in the hypothetical RCT and 70 (18.4%) might be willing to participate. Amongst the 70 women in the subgroup 11 women (15.7%) would be willing to participate and 17 (24.3%) might be willing to participate. Discussion and conclusionCalculating sample size in a country with a low CS rate, in relation to 69.2% of women are not willing to participate in an RCT comparing IOL at 39 weeks with EM, would require >18.000 women to be counselled for participation. We believe such a study is a challenge in the Netherlands

Early nasogastric tube feeding in optimising treatment for hyperemesis gravidarum: The MOTHER randomised controlled trial (Maternal and Offspring outcomes after Treatment of HyperEmesis by Refeeding)

Background: Hyperemesis gravidarum (HG), or intractable vomiting during pregnancy, is the single most frequent cause of hospital admission in early pregnancy. HG has a major impact on maternal quality of life and has repeatedly been associated with poor pregnancy outcome such as low birth weight. Currently, women with HG are admitted to hospital for intravenous fluid replacement, without receiving specific nutritional attention. Nasogastric tube feeding is sometimes used as last resort treatment. At present no randomised trials on dietary or rehydration interventions have been performed. Small observational studies indicate that enteral tube feeding may have the ability to effectively treat dehydration and malnutrition and alleviate nausea and vomiting symptoms. We aim to evaluate the effectiveness of early enteral tube feeding in addition to standard care on nausea and vomiting symptoms and pregnancy outcomes in HG patients. Methods/Design: The MOTHER trial is a multicentre open label randomised controlled trial ( www.studies-obsgyn.nl/mother ). Women ≥ 18 years hospitalised for HG between 5 + 0 and 19 + 6 weeks gestation are eligible for participation. After informed consent participants are randomly allocated to standard care with intravenous rehydration or early enteral tube feeding in addition to standard care. All women keep a weekly diary to record symptoms and dietary intake until 20 weeks gestation. The primary outcome will be neonatal birth weight. Secondary outcomes will be the 24-h Pregnancy Unique Quantification of Emesis and nausea score (PUQE-24), maternal weight gain, dietary intake, duration of hospital stay, number of readmissions, quality of life and side-effects. Also gestational age at birth, placental weight, umbilical cord plasma lipid concentration and neonatal morbidity will be evaluated. Analysis will be according to the intention to treat principle. Discussion: With this trial we aim to clarify whether early enteral tube feeding is more effective in treating HG than intravenous rehydration alone and improves pregnancy outcome. Trial registration: Trial registration number: NTR4197. Date of registration: October 2nd 2013

Кредитний механізм реалізації фінансової стратегії розвитку великого промислового регіону

Мета даної статті полягає в розробці на основі системного підходу концепції вдосконалення кредитного механізму реалізації фінансової стратегії розвитку великого промислового регіону, яка призведе до підвищення його прибутковості

Counseling and surveillance of obstetric risks for female childhood, adolescent, and young adult cancer survivors: recommendations from the International Late Effects of Childhood Cancer Guideline Harmonization Group

Female childhood, adolescent, and young adult cancer survivors have an increased risk of adverse pregnancy outcomes related to their cancer- or treatment-associated sequelae. Optimal care for childhood, adolescent, and young adult cancer survivors can be facilitated by clinical practice guidelines that identify specific adverse pregnancy outcomes and the clinical characteristics of at-risk subgroups. However, national guidelines are scarce and vary in content. Here, the International Late Effects of Childhood Cancer Guideline Harmonization Group offers recommendations for the counseling and surveillance of obstetrical risks of childhood, adolescent, and young adult survivors. A systematic literature search in MEDLINE database (through PubMed) to identify all available evidence published between January 1990 and December 2018. Published articles on pregnancy and perinatal or congenital risks in female cancer survivors were screened for eligibility. Study designs with a sample size larger than 40 pregnancies in childhood, adolescent, and young adult cancer survivors (diagnosed before the age of 25 years, not pregnant at that time) were eligible. This guideline from the International Late Effects of Childhood Cancer Guideline Harmonization Group systematically appraised the quality of available evidence for adverse obstetrical outcomes in childhood, adolescent, and young adult cancer survivors using Grading of Recommendations Assessment, Development, and Evaluation methodology and formulated recommendations to enhance evidence-based obstetrical care and preconception counseling of female childhood, adolescent, and young adult cancer survivors. Healthcare providers should discuss the risk of adverse obstetrical outcomes based on cancer treatment exposures with all female childhood, adolescent, and young adult cancer survivors of reproductive age, before conception. Healthcare providers should be aware that there is no evidence to support an increased risk of giving birth to a child with congenital anomalies (high-quality evidence). Survivors treated with radiotherapy to volumes exposing the uterus and their healthcare providers should be aware of the risk of adverse obstetrical outcomes such as miscarriage (moderate-quality evidence), premature birth (high-quality evidence), and low birthweight (high-quality evidence); therefore, high-risk obstetrical surveillance is recommended. Cardiomyopathy surveillance is reasonable before pregnancy or in the first trimester for all female survivors treated with anthracyclines and chest radiation. Female cancer survivors have increased risks of premature delivery and low birthweight associated with radiotherapy targeting the lower body and thereby exposing the uterus, which warrant high-risk pregnancy surveillance

Incidence, Indications, Risk Factors, and Outcomes of Emergency Peripartum Hysterectomy Worldwide: A Systematic Review and Meta-analysis

OBJECTIVE:To describe the incidence, indications, risk factors, outcomes, and management of emergency peripartum hysterectomy globally and to compare outcomes among different income settings.DATA SOURCES:PubMed, MEDLINE, EMBASE, ClinicalTrials.gov, Cochrane Library, Web of Science, and Emcare databases up to December 10, 2021.METHODS OF STUDY SELECTION:Update of a systematic review and meta-analysis (2016). Studies were eligible if they reported the incidence of emergency peripartum hysterectomy, defined as surgical removal of the uterus for severe obstetric complications up to 6 weeks postpartum. Title and abstract screening and full-text review were performed using Endnote data-management software. Of 8,775 articles screened, 26 were included that were published after 2015, making the total number of included studies 154. A subanalysis was performed for the outcomes of interest per income setting.TABULATION, INTEGRATION, AND RESULTS:The meta-analysis included 154 studies: 14,409 emergency peripartum hysterectomies were performed in 17,127,499 births in 42 countries. Overall pooled incidence of hysterectomy was 1.1 per 1,000 births (95% CI 1.0-1.3). The highest incidence was observed in lower middle-income settings (3/1,000 births, 95% CI 2.5-3.5), and the lowest incidence was observed in high-income settings (0.7/1,000 births, 95% CI 0.5-0.8). The most common indications were placental pathology (38.0%, 95% CI 33.9-42.4), uterine atony (27.0%, 95% CI 24.6-29.5), and uterine rupture (21.2%, 95% CI 17.8-25.0). In lower middle-income countries, uterine rupture (44.5%, 95% CI 36.6-52.7) was the most common indication; placental pathology (48.4%, 95% CI 43.5-53.4) was most frequent in high-income settings. To prevent hysterectomy, uterotonic medication was used in 2,706 women (17%): 53.2% received oxytocin, 44.6% prostaglandins, and 17.3% ergometrine. Surgical measures to prevent hysterectomy were taken in 80.5% of women, the most common being compressive techniques performed in 62.6% (95% CI 38.3-81.9). The most common complications were febrile (29.7%, 95% CI 25.4-34.3) and hematologic (27.5%, 95% CI 20.4-35.9). The overall maternal case fatality rate was 3.2 per 100 emergency peripartum hysterectomies (95% CI 2.5-4.2) and was higher in lower middle-income settings (11.2/100 emergency peripartum hysterectomies 95% CI 8.9-14.1) and lower in high-income settings (1.0/100 emergency peripartum hysterectomies 95% CI 0.6-1.6).CONCLUSION:Substantial differences across income settings exist in the incidence of emergency peripartum hysterectomy. Women in lower-income settings have a higher risk of undergoing emergency peripartum hysterectomy and suffer more procedure-related morbidity and mortality. The frequency of emergency peripartum hysterectomy is likely to increase in light of increasing cesarean delivery rates

Maternal cardiac arrest in the Netherlands: A nationwide surveillance study

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

Thromboprophylaxis with low-molecular-weight heparin insufficient in high-risk pregnancy

OBJECTIVE: To evaluate the efficacy and safety of thromboprophylaxis with a low of low-molecular-weight heparin (LMWH) in women with an intermediate to high risk of pregnancy-related venous thromboembolism (VTE).DESIGN: Retrospective cohort study.METHODS: We collected data from all pregnant women with an intermediate or high risk of VTE in the period 1996-2009. In accordance with protocol, pregnant women with an intermediate risk of VTE were treated with a prophylactic dose of LMWH for 6 weeks post partum, and pregnant women with a high risk were treated with a prophylactic dose of LMWH during the pregnancy and for 6 weeks post partum. Efficacy was defined as the incidence of VTE during pregnancy or &lt; 3 months post partum, and safety as the incidence of post-partum haemorrhage (PPH) (&gt; 500 ml blood loss) or severe PPH (&gt; 1,000 ml blood loss).RESULTS: We analysed 34 women (44 pregnancies) with an intermediate risk and 57 women (82 pregnancies) with a high risk of VTE. The incidence of pregnancy-related VTE despite thromboprophylaxis was 5.5% (95% CI: 2.4-12.3). All VTEs occurred in high-risk women, and risk was higher post partum than ante partum: 7.0% (95% CI: 2.9-16.7) and 1.8% (95% CI: 0.4-9.2%), respectively. The risk of PPH was 21.6% (95% CI: 14.3-31.3) and of severe PPH 9.1% (95% CI: 4.7-16.9) and was comparable in women who used LMWH during pregnancy and those who started LMWH post partum.CONCLUSION: There was a considerable risk of pregnancy-related VTE in high-risk women despite a prophylactic dose of LMWH during pregnancy and in the post partum period. For these women thromboprophylaxis with a low, prophylactic dose of LMWH appeared to be insufficient.</p