A collagen plug with shape memory to seal iatrogenic fetal membrane defects after fetoscopic surgery.

Iatrogenic preterm premature rupture of fetal membranes (iPPROM) after fetal surgery remains a strong trigger for premature birth. As fetal membrane defects do not heal spontaneously and amniotic fluid leakage and chorioamniotic membrane separation may occur, we developed a biocompatible, fetoscopically-applicable collagen plug with shape memory to prevent leakage. This plug expands directly upon employment and seals fetal membranes, hence preventing amniotic fluid leakage and potentially iPPROM. Lyophilized type I collagen plugs were given shape memory and crimped to fit through a fetoscopic cannula (Ø 3 mm). Expansion of the plug was examined in phosphate buffered saline (PBS). Its sealing capacity was studied ex vivo using human fetal membranes, and in situ in a porcine bladder model. The crimped plug with shape memory expanded and tripled in diameter within 1 min when placed into PBS, whereas a crimped plug without shape memory did not. In both human fetal membranes and porcine bladder, the plug expanded in the defect, secured itself and sealed the defect without membrane rupture. In conclusion, collagen plugs with shape memory are promising as medical device for rapid sealing of fetoscopic defects in fetal membranes at the endoscopic entry point.

Maternal anxiety forecasts shorter prolongation of pregnancies complicated by early-onset preeclampsia.

PURPOSE: In early-onset preeclampsia, each additional day of pregnancy prolongation reduces offspring infant mortality about 9%. We evaluated if maternal stress at admission to hospital for early-onset preeclampsia predicted admission-to-delivery intervals in days. METHODS: This prospective, longitudinal cohort-study involved 15 singleton pregnancies with a diagnosis of preeclampsia before 34 weeks gestation with intended expectant management. Upon hospital admission, maternal psychological stress was assessed with questionnaires and physiological stress with hair cortisol. Hair samples were analyzed in three hair segments representing the preconception period, and the first and second trimester of pregnancy. RESULTS: Mean pregnancy prolongation was 16.2 days. Higher maternal anxiety at hospital admission significantly correlated with shorter admission-to-delivery intervals (r = - 0.54, p = 0.04). Chronically increased hair cortisol concentrations (i.e. from preconception through the second trimester) of pregnancy tended to be related to shorter admission-to-delivery intervals (p <. 10). CONCLUSION: Higher reported anxiety is, and chronically high hair cortisol tended to be, related with fewer days of prolongation from admission to delivery in women with early-onset preeclampsia. These findings suggest that maternal stress might be a potential determinant of disease progression. Future research into early innovative stress-reducing interventions for early-onset preeclampsia may shed more light on the etiology and treatment of this disease.

Use of holmium laser for umbilical cord transection in a monoamniotic pregnancy threatened by an acardiac co-twin: a case report.

BACKGROUND: Twin reversed arterial perfusion sequence is a rare complication of monochorionic multifetal pregnancies. In this syndrome, the acardiac twin has a nonfunctional heart, while the other twin, the pump twin, has normal development. The pump twin perfuses the acardiac twin and is therefore at risk for cardiac decompensation. In monoamniotic cases, the normal co-twin is also at risk of sudden death due to cord entanglement. Treatment consists of coagulation and transection of the acardiac's umbilical cord. We report the first intrauterine use in pregnancy of a Ho:yttrium aluminum garnet laser to safely and successfully transect the umbilical cord after Nd:yttrium aluminum garnet coagulation. CASE PRESENTATION: A 30-year-old Caucasian woman was referred to our fetal-maternal medicine unit at 9 weeks gestation with a monochorionic-monoamniotic twin pregnancy complicated by an acardiac twin. After counseling, she opted for an elective intervention to minimize the risks to the pump twin. At 16 weeks, fetoscopy was performed using a single 2-mm entry port. Through this port, a 1.0-mm fetoscope and a 0.365-mm laser fiber were introduced. Under fetoscopic sight and ultrasound (Doppler) guidance, the umbilical cord of the acardiac twin was first coagulated by laser energy using a Nd:yttrium aluminum garnet laser and then, using the same fiber, transected using a Ho:yttrium aluminum garnet laser. The patient underwent cesarean section at 38 weeks and delivered a healthy baby. CONCLUSIONS: We present the first report on intrauterine use of an Ho:yttrium aluminum garnet laser in human pregnancy. Ho:yttrium aluminum garnet laser energy can be successfully and safely used for umbilical cord transection and carries fewer risks than other methods of transection.

Economic evaluation of a randomized controlled trial comparing mifepristone and misoprostol with misoprostol alone in the treatment of early pregnancy loss.

BACKGROUND: In case of early pregnancy loss (EPL) women can either choose for expectant, medical or surgical management. One week of expectant management is known to lead to spontaneous abortion in approximately 50% of women. Medical treatment with misoprostol is known to be safe and less costly than surgical management, however less effective in reaching complete evacuation of the uterus. Recently, a number of trials showed that prompt treatment with the sequential combination of mifepristone with misoprostol is superior to misoprostol alone in reaching complete evacuation. In this analysis we evaluate whether the sequential combination of mifepristone with misoprostol is cost-effective compared to misoprostol alone, in the treatment of EPL. METHODS AND FINDINGS: A cost-effectiveness analysis (CEA) from a healthcare perspective was performed alongside a randomised controlled trial (RCT) in which standard treatment with misoprostol only was compared with a combination of mifepristone and misoprostol, in women with EPL after a minimum of one week of unsuccessful management. A limited societal perspective scenario was added. This RCT, the Triple M trial, was a multicentre, randomized, double-blinded, placebo-controlled trial executed at 17 hospitals in the Netherlands. The trial started on June 27th 2018, and ended prematurely in January 2020 due to highly significant outcomes from the predefined interim-analysis. We included 351 women with a diagnosis of EPL between 6 and 14 weeks gestation after at least one week of unsuccessful expectant management. They were randomized between double blinded pre-treatment with oral mifepristone 600mg (N = 175) or placebo (N = 176) taken on day one, both followed by misoprostol orally. In both groups, an intention-to-treat analysis was performed for 172 patients, showing a significant difference in success rates between participants treated with mifepristone and misoprostol versus those treated with misoprostol alone (79.1% vs 58.7% respectively). In this cost-effective analysis we measured the direct, medical costs related to treatment (planned and unplanned hospital visits, medication, additional treatment) and indirect costs based on the IMTA Productivity Cost Questionnaire (iPCQ). Quality Adjusted Life Years (QALY's) were calculated from participants' scores on the SF-36 questionnaires sent digitally at treatment start, and one, two and six weeks later. We found medical treatment with placebo followed by misoprostol to be 26% more expensive compared to mifepristone followed by misoprostol (p = 0.001). Mean average medical costs per patient were significantly lower in the mifepristone group compared to the placebo group (€528.95 ± 328.93 vs €663.77 ± 456.03, respectively; absolute difference €134.82, 95% CI 50,46-219,18, p = 0.002). Both indirect costs and QALY's were similar between both groups. CONCLUSION: The sequential combination of mifepristone with misoprostol is cost-effective compared with misoprostol alone, for treatment of EPL after a minimum of one week of unsuccessful expectant management.

Effects of a Personal Health Record in Maternity Care: A Stepped-Wedge Trial.

To improve both the active involvement of pregnant women in their maternal health and multidisciplinary collaboration between maternal care professionals, we introduced a personal health record (PHR) in routine maternity care. We studied the effects of this intervention on the percentage of uncomplicated births, women's perspectives on quality of care, and the collaboration between health care professionals. We performed a stepped-wedge cluster randomized controlled trial with four clusters and 13 maternity health centers (community-based midwife practices and hospitals) in one collaborative area. In total, 7350 pregnant women and 220 health care professionals participated. Uncomplicated births accounted for 51.8% (95% CI 50.1-53.9%) of total births in the control group and 55.0% (CI 53.5-56.5%) of total births in the intervention group (p = 0.289). Estimated means revealed that the differences detected in the stepped-wedge study were due to time and not the intervention. Women's perspectives on quality of care and collaboration between health care professionals revealed no relevant differences between the control and intervention groups. The introduction of the PHR resulted in no significant effect on the chosen measures of quality of maternal care. The suggested positive effect in the raw data was a local trend which was less visible in the national database, and thus might be related to subtle changes toward an improved collaborative culture in the study region.

Differences in hair cortisol concentrations and reported anxiety in women with preeclampsia versus uncomplicated pregnancies.

This Dutch multicenter case-controlled study investigated whether cortisol concentrations and psychosocial stress during pregnancy differed between women with early-onset preeclampsia, late-onset preeclampsia, and uncomplicated pregnancies. Cortisol concentrations were analyzed in three hair segments representing the preconception period, first, and second trimester of pregnancy. Cortisol trajectories differed, with early-onset preeclampsia showing steeper increases in cortisol and higher cortisol concentrations during the second trimester. Reported anxiety in women with preeclampsia was higher compared to women with uncomplicated pregnancies. These results indicate that measures of cortisol and reported anxiety differ between early-onset, late-onset preeclampsia, and uncomplicated pregnancies.

Acardius anceps with neck cyst and cleft palate: Three dimensional skeletal computed tomography reconstruction with discussion of the literature.

Acardiac twinning is a rare anomaly of monochorionic twin pregnancies. Acardiac fetuses lack a functional heart but are passively perfused by arterial blood from their pump co-twin causing the acardiac body to be hypoxemic. In this report, we present an acardius anceps, therapeutically laser separated from its pump twin at 16 weeks. The healthy pump twin and macerated acardiac body were born at 40 3/7 weeks. A three dimensional (3D) reconstruction was made by CT images, showing cranial bones, spinal column, pelvis and lower extremities but absent arms. A cyst in the neck of the acardiac twin was identified by postnatal sonography; this was also described in four literature cases, and was additionally observed by us in two other acardiac twins. Median cleft palate was identified by oral cavity inspection but undetectable in the reconstruction. In the literature, we found 21 other acardiac anceps twins with a cleft palate. From the two larger published series, with 12 clefts in 21 acardiac anceps twins, a cleft palate occurs in over 50% during acardiac twinning. Our first hypothesis is that acardiac fetuses develop an oral cleft palate when acardiac onset starts prior to 11 weeks, because 11 weeks includes the period of embryonic oral cavity formation, and no cleft occurs when onset starts later than 11 weeks. Our second hypothesis is that cysts and cleft palates are more common in acardiac twins than currently known, likely reflecting that acardiac bodies are hypoxemic and that hypoxia contributes to the development of both cysts and clefts.

Mifepristone and misoprostol versus misoprostol alone for uterine evacuation after early pregnancy failure: study protocol for a randomized double blinded placebo-controlled comparison (Triple M Trial).

BACKGROUND: Early pregnancy failure (EPF) is a common complication of pregnancy. If women do not abort spontaneously, they will undergo medical or surgical treatment in order to remove the products of conception from the uterus. Curettage, although highly effective, is associated with a risk of complications; medical treatment with misoprostol is a safe and less expensive alternative. Unfortunately, after 1 week of expectant management in case of EPF, medical treatment with misoprostol has a complete evacuation rate of approximately 50%. Misoprostol treatment results may be improved by pre-treatment with mifepristone; its effectiveness has already been proven for other indications of pregnancy termination. This study will test the hypothesis that, in EPF, the sequential combination of mifepristone with misoprostol is superior to the use of misoprostol alone in terms of complete evacuation (primary outcome), patient satisfaction, complications, side effects and costs (secondary outcomes). METHODS: The trial will be performed multi-centred, prospectively, two-armed, randomised, double-blinded and placebo-controlled. Women with confirmed EPF by ultrasonography (6-14 weeks), managed expectantly for at least 1 week, can be included and randomised to pre-treatment with oral mifepristone (600 mg) or oral placebo (identical in appearance). Randomisation will take place after receiving written consent to participate. In both arms pre-treatment will be followed by oral misoprostol, which will start 36-48 h later consisting of two doses 400 µg (4 hrs apart), repeated after 24 h if no tissue is lost. Four hundred sixty-four women will be randomised in a 1:1 ratio, stratified by centre. Ultrasonography 2 weeks after treatment will determine short term treatment effect. When the gestational sac is expulsed, expectant management is advised until 6 weeks after treatment when the definitive primary endpoint, complete or incomplete evacuation, will be determined. A sonographic endometrial thickness < 15 mm using only the allocated therapy by randomisation is considered as successful treatment. Secondary outcome measures (patient satisfaction, complications, side effects and costs) will be registered using a case report form, patient diary and validated questionnaires (Short Form 36, EuroQol-VAS, Client Satisfaction Questionnaire, iMTA Productivity Cost Questionnaire). DISCUSSION: This trial will answer the question if, in case of EPF, after at least 1 week of expectant management, sequential treatment with mifepristone and misoprostol is more effective than misoprostol alone to achieve complete evacuation of the products of conception. TRIAL REGISTRATION: Clinicaltrials.gov (d.d. 02-07-2017): NCT03212352. Trialregister.nl (d.d. 03-07-2017): NTR6550. EudraCT number (d.d. 07-08-2017): 2017-002694-19. File number Commisie Mensgebonden Onderzoek (d.d. 07-08-2017): NL 62449.091.17.

Current and future expectations of mifepristone treatment in early pregnancy failure: a survey among Dutch gynaecologists.

To investigate the current and future addition of mifepristone to misoprostol treatment in case of early pregnancy failure (EPF), a digital questionnaire was distributed to a representative sample of all Dutch hospitals (25/79). In non-teaching centres, the presence of a local protocol was significantly lower compared to academic and teaching hospitals (p=.012). If a local protocol was present, the first choice of treatment was medical in 54.5%. Four respondents (16%) always prescribed mifepristone in case of EPF. The most common reason not prescribing mifepristone was the lack of sufficient scientific evidence. An average increase in success rate of 21.7% was desired to prescribe mifepristone in the future for EPF. Completeness of evacuation of products of conception from the uterus was usually assessed after 1 week by ultrasonography combined with clinical signs. If a complete evacuation was not achieved by the initial medical treatment, expectant management was proposed just as often as surgical intervention. Impact Statement What is already known on this subject? In case of early pregnancy failure (EPF), women can choose from both expectant medical (misoprostol, whether or not combined with mifepristone) and surgical (D and C) treatment. In The Netherlands, a national guideline concerning the treatment of EPF is still lacking. A questionnaire performed by Verschoor et al. ( 2014 ) showed there was a large practice variety between Dutch clinics. What the results of this study add? In this study, a representative sample of all Dutch clinics received a questionnaire about the treatment of EPF. The results confirm a large practice variation regarding treatment of EPF. The first choice of treatment, the medical treatment regimen, and the assessment of whether or not the treatment have been variations of successful between clinics. With regards to the addition of mifepristone to the medical treatment regime with misoprostol, gynaecologists are willing to consider mifepristone if an improvement of efficacy of approximately 20% is scientifically proven. What the implications are of these findings for clinical practice and/or further research? In our opinion, these results emphasise the need for a national guideline concerning the treatment of EPF. Our results also demonstrate that, if the addition of mifepristone to medical treatment with misoprostol proves to be more efficient than misoprostol alone, gynaecologists are willing to prescribe mifepristone in the future. Whether the addition is indeed more effective than misoprostol alone, will be the subject of a multicentre, double-blind, placebo-controlled randomised controlled trial, planned to begin in the first half of 2018.

Management of late-term pregnancy in midwifery- and obstetrician-led care.

Management of late-term pregnancy in midwifery- and obstetrician-led care. BACKGROUND: Since there is no consensus regarding the optimal management in late-term pregnancies (≥41.0 weeks), we explored the variety of management strategies in late-term pregnancy in the Netherlands to identify the magnitude of this variety and the attitude towards late-term pregnancy. METHODS: Two nationwide surveys amongst all midwifery practices (midwifery-led care) and all hospitals with an obstetric unit (obstetrician-led care) were performed with questions on timing, frequency and content of consultations/surveillance in late-term pregnancy and on timing of induction. Propositions about late-term pregnancy were assessed using Likert scale questions. RESULTS: The response rate was 40% (203/511) in midwifery-led care and 92% (80/87) in obstetrician-led care. All obstetric units made regional protocols with their collaborating midwifery practices about management in late-term pregnancy. Most midwifery-led care practices (93%) refer low-risk women at least once for consultation in obstetrician-led care in late-term pregnancy. The content of consultations varies among hospitals. Membrane sweeping is performed more in midwifery-led care compared to obstetrician-led care (90% vs 31%, p < 0.001). Consultation at 41 weeks should be standard care according to 47% of midwifery-led care practices and 83% of obstetrician-led care units (p < 0.001). Induction of labour at 41.0 weeks is offered less often to women in midwifery-led care in comparison to obstetrician-led care (3% vs 21%, p < 0.001). CONCLUSIONS: Substantial practice variation exists within and between midwifery-and obstetrician-led care in the Netherlands regarding timing, frequency and content of antenatal monitoring in late-term pregnancy and timing of labour induction. An evidence based interdisciplinary guideline will contribute to a higher level of uniformity in the management in late- term pregnancies.

Perinatal death beyond 41 weeks pregnancy: an evaluation of causes and substandard care factors as identified in perinatal audit in the Netherlands.

BACKGROUND: Late- and postterm pregnancy are associated with adverse perinatal outcomes, like perinatal death. We evaluated causes of death and substandard care factors (SSFs) in term and postterm perinatal death. METHODS: We used data from the Perinatal Audit Registry of the Netherlands (PARS). Women with a term perinatal death registered in PARS were stratified by gestational age into early-/full-term (37.0-40.6) and late-/postterm (≥41.0 weeks) death. Cause of death and SSFs ≥41 weeks were scored and classified by the local perinatal audit teams. RESULTS: During 2010-2012, 947/479,097 (0.21%) term deaths occurred, from which 707 cases (75%) were registered and could be used for analyses. Five hundred ninety-eight early-/full-term and 109 late-/postterm audited deaths were registered in the PARS database. Of all audited cases of perinatal death in the PARS database, 55.2% in the early-/fullterm group occurred antepartum compared to 42.2% in the late-/postterm group, while intrapartum death occurred in 7.2% in the early-/full-term group compared to 19.3% in the late-/postterm group in the audited cases from the PARS database. According to the local perinatal audit, the most relevant causes of perinatal death ≥41 weeks were antepartum asphyxia (7.3%), intrapartum asphyxia (9.2%), neonatal asphyxia (10.1%) and placental insufficiency (10.1%). In the group with perinatal death ≥41 weeks there was ≥1SSF identified in 68.8%. The most frequent SSFs concerned inadequate cardiotocography (CTG) evaluation and/or classification (10.1%), incomplete registration or documentation in medical files (4.6%) or inadequate action on decreased foetal movements (4.6%). CONCLUSIONS: In the Netherlands Perinatal Audit Registry, stillbirth occurred relatively less often antepartum and more often intrapartum in pregnancies ≥41 weeks compared to pregnancies at 37.0-40.6 weeks in the audited cases from the PARS database. Foetal, intrapartum and neonatal asphyxia were identified more frequently as cause of death in pregnancies ≥41 weeks. The most identified SSFs related to death in pregnancies ≥41 weeks concerned inadequate CTG monitoring (evaluation, classification, registration or documentation) and inadequate action on decreased foetal movements.

Major obstetric hemorrhage: Patients' perspective on the quality of care.

OBJECTIVES: Major obstetric hemorrhage (MOH) is the leading cause of severe maternal morbidity and mortality, and can have a significant impact on a woman's life. This study aims to gain insight into the patients reported experiences (PREs) and outcomes (PROs) after a major obstetric hemorrhage, and to investigate which patients are most at risk for negative experiences. MATERIAL AND METHODS: A Consumer Assessment of Healthcare Providers and Systems (CAHPS) based questionnaire was developed covering items on the PREs and PROs, and send to all patients with blood loss exceeding 2500 ml in six hospitals over the period of 2008-2012. A regression analysis was performed to find determinants for negative experiences. RESULTS: In total 372 of the 570 questionnaires were returned. Women scored the overall care before, during and after the MOH with a mean of 7.67, 7.62 and 7.28, respectively. However, most PRE items individually were scored suboptimal, with items regarding information supply scoring the lowest. Our results on the PROs showed 81% of the women (362) sustaining extreme fatigue, whereas problems with concentration (53% of 373 women), memory (49% of 353), or reliving (49% of 356) and irritability (51% of 355) were also frequently endured. Negative long term effects were observed in 28% of the women (106 of 372). We found 'year of the MOH longer ago', 'a lower total blood loss' and 'a large location of birth' to be determinants for negative experiences. CONCLUSIONS: Women frequently reported negative experiences and outcomes following a MOH. Information supply after an MOH concerning both physical and psychological complaints is essential for the improvement of care.

Development of a tailored strategy to improve postpartum hemorrhage guideline adherence.

BACKGROUND: Despite the introduction of evidence based guidelines and practical courses, the incidence of postpartum hemorrhage shows an increasing trend in developed countries. Substandard care is often found, which implies an inadequate implementation in high resource countries. We aimed to reduce the gap between evidence-based guidelines and clinical application, by developing a strategy, tailored to current barriers for implementation. METHODS: The development of the implementation strategy consisted of three phases, supervised by a multidisciplinary expert panel. In the first phase a framework of the strategy was created, based on barriers to optimal adherence identified among professionals and patients together with evidence on effectiveness of strategies found in literature. In the second phase, the tools within the framework were developed, leading to a first draft. In the third phase the strategy was evaluated among professionals and patients. The professionals were asked to give written feedback on tool contents, clinical usability and inconsistencies with current evidence care. Patients evaluated the tools on content and usability. Based on the feedback of both professionals and patients the tools were adjusted. RESULTS: We developed a tailored strategy to improve guideline adherence, covering the trajectory of the third trimester of pregnancy till the end of the delivery. The strategy, directed at professionals, comprehending three stop moments includes a risk assessment checklist, care bundle and time-out procedure. As patient empowerment tools, a patient passport and a website with patient information was developed. The evaluation among the expert panel showed all professionals to be satisfied with the content and usability and no discrepancies or inconsistencies with current evidence was found. Patients' evaluation revealed that the information they received through the tools was incomplete. The tools were adjusted accordingly to the missing information. CONCLUSION: A usable, tailored strategy to implement PPH guidelines and practical courses was developed. The next step is the evaluation of the strategy in a feasibility trial. TRIAL REGISTRATION: Clinical trial registration: The Fluxim study, registration number: NCT00928863 .

Subsequent pregnancy outcome after mid-trimester termination of pregnancy for preeclampsia.

BACKGROUND: In this study we determined the outcome of subsequent pregnancies after termination of pregnancy for preeclampsia, with the purpose of presenting data useful for counselling these women on future pregnancies. STUDY DESIGN: The cohort consisted of 131 women with a history of termination of pregnancy for preeclampsia. RESULTS: Data of 79 pregnancies were available for analysis, including 13 women with chronic hypertension and 16 women with thrombophilia. There were seven miscarriages (8.8%) and 72 ongoing pregnancies. Low-dose aspirin was prescribed for 64 women (89%). The mean gestational age at delivery was 356/7 ± 4 weeks with a mean birth weight of 2571 ± 938 g. Overall recurrence rate for preeclampsia was 29% at a mean gestational age of 32 weeks. Thirty-eight women had an uncomplicated pregnancy (53%). The women with chronic hypertension had the highest recurrence rate of 38%. Neonatal mortality was 4%. CONCLUSION: The course of subsequent pregnancies after mid-trimester termination for preeclampsia is uncomplicated in 53% with a recurrence rate for preeclampsia of 29%. The mean gestational age at delivery was 11 weeks later and birth weight 2000 g higher than in the index pregnancy.

Shared agenda making for quality improvement; towards more synergy in maternity care.

OBJECTIVES: Professionals in maternity care have started working in a network approach. To further enhance the efficacy of this multidisciplinary maternity network, the identification of priorities for improvement is warranted. The aim of this study was to create key recommendations for the improvement agenda, in co-production with patients and professionals. STUDY DESIGN: We conducted a Delphi study to inventory (round 1), prioritize (round 2) and eventually approve (round 3) the improvement agenda for the maternity network. Both patients and professionals joined this study. Initial input for the study consisted of experiences from 397 patients, collected using the ReproQ questionnaire. In round 1, the expert panel, gave improvement recommendations, based on the ReproQ results. This resulted in 11 recommendations. In the second round, the expert panel prioritised these recommendations. In the consensus meeting then finally the concrete improvement agenda was composed. RESULTS: Priority scores differed considerably between patients and professionals in seven items, while four items received similar priority scores from both groups. The four most important improvement activities were: Realise more single bedrooms in hospitals; Create more opportunities for the continued presence of the community midwife during labour; Initiate a digital patient record view system for the network with a view function for patients; and Introduce a case manager for pregnant woman. CONCLUSION: Based on patient experience and the active involvement of patients and professionals, we were able to compose the shared agenda for quality improvement in maternity care.

Which Factors Contribute to False-Positive, False-Negative, and Invalid Results in Fetal Fibronectin Testing in Women with Symptoms of Preterm Labor?

Objective We assessed the influence of external factors on false-positive, false-negative, and invalid fibronectin results in the prediction of spontaneous delivery within 7 days. Methods We studied symptomatic women between 24 and 34 weeks' gestational age. We performed uni- and multivariable logistic regression to estimate the effect of external factors (vaginal soap, digital examination, transvaginal sonography, sexual intercourse, vaginal bleeding) on the risk of false-positive, false-negative, and invalid results, using spontaneous delivery within 7 days as the outcome. Results Out of 708 women, 237 (33%) had a false-positive result; none of the factors showed a significant association. Vaginal bleeding increased the proportion of positive fetal fibronectin (fFN) results, but was significantly associated with a lower risk of false-positive test results (odds ratio [OR], 0.22; 95% confidence intervals [CI], 0.12-0.39). Ten women (1%) had a false-negative result. None of the investigated factors was significantly associated with a significantly higher risk of false-negative results. Twenty-one tests (3%) were invalid; only vaginal bleeding showed a significant association (OR, 4.5; 95% CI, 1.7-12). Conclusion The effect of external factors on the performance of qualitative fFN testing is limited, with vaginal bleeding as the only factor that reduces its validity.

Use of social network analysis in maternity care to identify the profession most suited for case manager role.

OBJECTIVE: To improve Dutch maternity care, professionals start working in interdisciplinary patient-centred networks, which includes the patients as a member. The introduction of the case manager is expected to work positively on both the individual and the network level. However, case management is new in Dutch maternity care. The present study aims to define the profession that would be most suitable to fulfil the role of case manager. DESIGN: The maternal care network in the Nijmegen region was determined by using Social Network Analysis (SNA). SNA is a quantitative methodology that measures and analyses patient-related connections between different professionals working in a network. To identify the case manager we focused on the position, reach, and connections in the network of the maternal care professionals. SETTING: Maternity healthcare professionals in a single region of the Netherlands with an average of 4,500 births/year. PARTICIPANTS: The participants were 214 individual healthcare workers from eight different professions. MEASUREMENTS AND FINDINGS: The total network showed 3948 connections between 214 maternity healthcare professionals with a density of 0.08. Each profession had some central individuals in the network. The 52 community-based midwives were responsible for 51% of all measured connections. The youth health doctors and nurses were mostly situated on the periphery and less connected. The betweenness centrality had the highest score in obstetricians and community-based midwives. Only the community-based midwives had connections with all other groups of professions. Almost all professionals in the network could reach other professionals in two steps.

Comparison of the Actim Partus test and the fetal fibronectin test in the prediction of spontaneous preterm birth in symptomatic women undergoing cervical length measurement.

OBJECTIVE: To compare the accuracy of the Actim Partus test and fetal fibronectin (fFN) test in the prediction of spontaneous preterm delivery within seven days in symptomatic women undergoing cervical length measurement. STUDY DESIGN: We performed a post-hoc analysis on frozen samples of a nationwide cohort study in all 10 perinatal centres in the Netherlands. We selected samples from women with signs of preterm labour between 24 and 34 weeks of gestational age and a cervical length below 30mm. Delivery within seven days after initial assessment was the primary endpoint. We calculated sensitivity, specificity, and positive and negative predictive values for the combination of both the Actim Partus test and fFN test with cervical length. A test was considered positive in case of a cervical length between 15 and 30mm with a positive Actim Partus or fFN test, and a cervical length below 15mm regardless the test result. RESULTS: In total, samples of 350 women were tested, of whom 69 (20%) delivered within seven days. Eighty-four women had a positive Actim Partus test and 162 women a positive fFN test, of whom 54 (64%) and 63 (39%) delivered within seven days, respectively. Ninety-seven women had a cervical length below 15mm, of whom 50 (52%) delivered within seven days. Sensitivity, specificity, positive and negative predictive values of combining cervical length with the Actim Partus test or the fFN test were 91%, 75%, 47% and 97%, and 96%, 58%, 36% and 98%, respectively. CONCLUSION: According to this post-hoc study, in combination with cervical length, the Actim Partus test could be used as an alternative for the fFN test to identify women who will not deliver within seven days after presentation. Further evidence should be collected in a prospective comparative study.

Terminating pregnancy for severe hypertension when the fetus is considered non-viable: a retrospective cohort study.

OBJECTIVE: To investigate frequency and practise of termination of pregnancy for early-onset hypertensive disorders where the fetus is considered to be non-viable. STUDY DESIGN: Retrospective cohort study in all Dutch tertiary perinatal care centres (n=10), between January 2000 and January 2014. All women who underwent termination of pregnancy, without fetal surveillance or intention to intervene for fetal reasons, for early-onset hypertensive disorders in pregnancy, were analyzed. Women eligible for this study were identified in the local delivery databases. Medical records were used to collect relevant data. RESULTS: Between January 2000 and January 2014, 2,456,584 women delivered in The Netherlands, of which 238,448 (9.7%) in a tertiary care centre. A total of 161 pregnancy terminations (11-12 per year) for severe early-onset preeclampsia were identified, including 6 women with a twin pregnancy. Mean gestational age at termination was 172 days (GA 244/7)±9.4 days. In 70% of cases termination was performed at or shortly after 24 weeks' gestation. 74.5% of women developed HELLP syndrome (n=96), eclampsia (n=10) or needed admission to an ICU (n=14). Birth weight was below 500g in 64% of cases. In 69% of the cases the estimated fetal weight was within a 10% margin of the actual birth weight. CONCLUSION: Termination of pregnancy for early-onset hypertensive disorders without intervention for fetal indication occurs approximately 12 times per year in The Netherlands. More data are needed to investigate contemporary best practice regarding termination of pregnancy for early-onset hypertensive indications at the limits of fetal viability. Considering the frequency of maternal complications, termination of pregnancy and not expectant management should be considered for all women presenting with severe early onset hypertensive disorders at the limits of fetal viability.

Improving maternity care using a personal health record: study protocol for a stepped-wedge, randomised, controlled trial.

BACKGROUND: A personal health record (PHR) is an online application through which individuals can access, manage, and share their health information in a private, secure, and confidential environment. Personal health records empower patients, facilitate collaboration among healthcare professionals, and improve health outcomes. Given these anticipated positive effects, we want to implement a PHR, named MyPregn@ncy, in a Dutch maternity care setting and to evaluate its effects in routine care. This paper presents the study protocol. METHODS/DESIGN: The effects of implementing a PHR in maternity care on patients and professionals will be identified in a stepped-wedge, cluster-randomised, controlled trial. The study will be performed in the region of Nijmegen, a Dutch area with an average of 4,500 births a year and more than 230 healthcare professionals involved in maternity care. Data analyses will describe the effects of MyPregn@ncy on health outcomes in maternity care, quality of care from the patients' perspectives, and collaboration among healthcare professionals. Additionally, a process evaluation of the implementation of MyPregn@ncy will be performed. Data will be collected using data from the Dutch perinatal registry, questionnaires, interviews, and log data. DISCUSSION: The study is expected to yield new information about the effects, strengths, possibilities, and challenges to the implementation and usage of a PHR in routine maternal care settings. Results may lead to new insights and improvements in the quality of maternal and perinatal care. TRIAL REGISTRATION: Netherlands Trial Register: NTR4063.