Surgical treatment for tubal disease in women due to undergo in vitro fertilisation.

BACKGROUND: Tubal disease accounts for 20% of infertility cases. Hydrosalpinx, caused by distal tubal occlusion leading to fluid accumulation in the tube(s), is a particularly severe form of tubal disease negatively affecting the outcomes of assisted reproductive technology (ART). It is thought that tubal surgery may improve the outcome of ART in women with hydrosalpinges. OBJECTIVES: To assess the effectiveness and safety of tubal surgery in women with hydrosalpinges prior to undergoing conventional in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI). SEARCH METHODS: We searched the Cochrane Gynaecology and Fertility (CGF) Group trials register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, DARE, and two trial registers on 8 January 2020, together with reference checking and contact with study authors and experts in the field to identify additional trials. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing surgical treatment versus no surgical treatment, or comparing surgical interventions head-to-head, in women with tubal disease prior to undergoing IVF. DATA COLLECTION AND ANALYSIS: We used Cochrane's standard methodological procedures. The primary outcomes were live birth rate (LBR) and surgical complication rate per woman randomised. Secondary outcomes included clinical, multiple and ectopic pregnancy rates, miscarriage rates and mean numbers of oocytes retrieved and of embryos obtained. MAIN RESULTS: We included 11 parallel-design RCTs, involving a total of 1386 participants. The included trials compared different types of tubal surgery (salpingectomy, tubal occlusion or transvaginal aspiration of hydrosalpingeal fluid) to no tubal surgery, or individual interventions to one another. We assessed no studies as being at low risk of bias across all domains, with the main limitations being lack of blinding, wide confidence intervals and low event and sample sizes. We used GRADE methodology to rate the quality of the evidence. Apart from one moderate-quality result in one review comparison, the evidence provided by these 11 trials ranged between very low- to low-quality. Salpingectomy versus no tubal surgery No included study reported on LBR for this comparison. We are uncertain of the effect of salpingectomy on surgical complications such as the rate of conversion to laparotomy (Peto odds ratio (OR) 5.80, 95% confidence interval (CI) 0.11 to 303.69; one RCT; n = 204; very low-quality evidence) and pelvic infection (Peto OR 5.80, 95% CI 0.11 to 303.69; one RCT; n = 204; very low-quality evidence). Salpingectomy probably increases clinical pregnancy rate (CPR) versus no surgery (risk ratio (RR) 2.02, 95% CI 1.44 to 2.82; four RCTs; n = 455; I2 = 42.5%; moderate-quality evidence). This suggests that in women with a CPR of approximately 19% without tubal surgery, the rate with salpingectomy lies between 27% and 52%. Proximal tubal occlusion versus no surgery No study reported on LBR and surgical complication rate for this comparison. Tubal occlusion may increase CPR compared to no tubal surgery (RR 3.21, 95% CI 1.72 to 5.99; two RCTs; n = 209; I2 = 0%; low-quality evidence). This suggests that with a CPR of approximately 12% without tubal surgery, the rate with tubal occlusion lies between 21% and 74%. Transvaginal aspiration of hydrosalpingeal fluid versus no surgery No study reported on LBR for this comparison, and there was insufficient evidence to identify a difference in surgical complication rate between groups (Peto OR not estimable; one RCT; n = 176). We are uncertain whether transvaginal aspiration of hydrosalpingeal fluid increases CPR compared to no tubal surgery (RR 1.67, 95% CI 1.10 to 2.55; three RCTs; n = 311; I2 = 0%; very low-quality evidence). Laparoscopic proximal tubal occlusion versus laparoscopic salpingectomy We are uncertain of the effect of laparoscopic proximal tubal occlusion versus laparoscopic salpingectomy on LBR (RR 1.21, 95% CI 0.76 to 1.95; one RCT; n = 165; very low-quality evidence) and CPR (RR 0.81, 95% CI 0.62 to 1.07; three RCTs; n = 347; I2 = 77%; very low-quality evidence). No study reported on surgical complication rate for this comparison. Transvaginal aspiration of hydrosalpingeal fluid versus laparoscopic salpingectomy No study reported on LBR for this comparison, and there was insufficient evidence to identify a difference in surgical complication rate between groups (Peto OR not estimable; one RCT; n = 160). We are uncertain of the effect of transvaginal aspiration of hydrosalpingeal fluid versus laparoscopic salpingectomy on CPR (RR 0.69, 95% CI 0.44 to 1.07; one RCT; n = 160; very low-quality evidence). AUTHORS' CONCLUSIONS: We found moderate-quality evidence that salpingectomy prior to ART probably increases the CPR compared to no surgery in women with hydrosalpinges. When comparing tubal occlusion to no intervention, we found that tubal occlusion may increase CPR, although the evidence was of low quality. We found insufficient evidence of any effect on procedure- or pregnancy-related adverse events when comparing tubal surgery to no intervention. Importantly, none of the studies reported on long term fertility outcomes. Further high-quality trials are required to definitely determine the impact of tubal surgery on IVF and pregnancy outcomes of women with hydrosalpinges, particularly for LBR and surgical complications; and to investigate the relative efficacy and safety of the different surgical modalities in the treatment of hydrosalpinges prior to ART.

The effect of a preconception care outreach strategy: the Healthy Pregnancy 4 All study.

BACKGROUND: Preconception care has been acknowledged as an intervention to reduce perinatal mortality and morbidity. However, utilization of preconception care is low because of low awareness of availability and benefits of the service. An outreach strategy was employed to promote uptake of preconception care consultations. Its effect on the uptake of preconception care consultations was evaluated within the Healthy Pregnancy 4 All study. METHODS: We conducted a community-based intervention study. The outreach strategy for preconception care consultations included four approaches: (1) letters from municipal health services; (2) letters from general practitioners; (3) information leaflets by preventive child healthcare services and (4) encouragement by peer health educators. The target population was set as women aged 18 to 41 years in 14 Dutch municipalities with relatively high perinatal morbidity and mortality rates. We evaluated the effect of the outreach strategy by analyzing uptake of preconception care consultations between February 2013 and December 2014. Registration data of applications for preconception care as well as participant questionnaires were obtained for analysis. RESULTS: The outreach strategy led to 587 applications for preconception care consultations. The majority of applications (n = 424; 72%) were prompted by the invitation letters (132,129) from the municipalities and general practitioners. The effect of the municipal letter seemed to fade out after 3 months. CONCLUSIONS: Outreach strategies amongst the general population promote uptake of preconception care consultations, although on a small scale and with a temporary effect.

Developing social marketed individual preconception care consultations: Which consumer preferences should it meet?

AIMS: Preconception care (PCC) is care that aims to improve the health of offspring by addressing risk factors in the pre-pregnancy period. Consultations are recognized as a method to promote perinatal health. However, prospective parents underutilize PCC services. Uptake can improve if delivery approaches satisfy consumer preferences. Aim of this study was to identify preferences of women (consumers) as a first step to social marketed individual PCC consultations. METHODS: In depth, semi-structured interviews were performed to identify women's views regarding the four components of the social marketing model: product (individual PCC consultation), place (setting), promotion (how women are made aware of the product) and price (costs). Participants were recruited from general practices and a midwife's practice. Content analysis was performed by systematic coding with NVIVO software. RESULTS: The 39 participants reflected a multiethnic intermediately educated population. Product: Many participants had little knowledge of the need and the benefits of the product. Regarding the content of PCC, they wish to address fertility concerns and social aspects of parenthood. PCC was seen as an informing and coaching service with a predominant role for health-care professionals. PLACE: the general practitioner and midwife setting was the most mentioned setting. Promotion: A professional led promotion approach was preferred. Price: Introduction of a fee for PCC consultations will make people reconsider their need for a consultation and could exclude vulnerable patients from utilization. CONCLUSION: This study provides consumer orientated data to design a social marketed delivery approach for individual PCC consultations.

Barriers in the Uptake and Delivery of Preconception Care: Exploring the Views of Care Providers.

Objectives To examine health care professionals' views of their role and responsibilities in providing preconception care and identify barriers that affect the delivery and uptake of preconception care. Methods Twenty health care professionals who provide preconception care on a regular basis were interviewed using semi-structured interviews. Results We interviewed twelve community midwives, three General Practitioners, three obstetricians, one cardiologist specialized in congenital heart diseases and one gastroenterologist.We identified four barriers affecting the uptake and delivery of preconception care (PCC): (1) lack of a comprehensive preconception care program; (2) limited awareness of most future parents about the benefits of preconception care, hesitance of GP's about the necessity and effectiveness of PCC; (3) poor coordination and organization of preconception care; (4) conflicting views of health care professionals on pregnancy, reproductive autonomy of patients and professional responsibility. Conclusion We have identified four barriers in the uptake and delivery of preconception care. Our findings support the timely implementation of a comprehensive program of PCC (already advocated by the Health Council of the Netherlands) and increasing awareness and knowledge of PCC from care providers and future parents. We emphasize the need for further research on how organizational barriers lead to suboptimal PCC and how interdisciplinary collaboration and referral can lead to optimally tailored intervention approaches.

Evidence-based preconceptional lifestyle interventions.

Although the evidence for the associations between preconceptional risk factors and adverse pregnancy outcomes is extensive, the effectiveness of preconceptional interventions to reduce risk factors and to improve pregnancy outcomes remains partly unclear. The objective of this review is to summarize the available effectiveness of lifestyle interventions prior to pregnancy for women in terms of behavior change and pregnancy outcome. A predefined search strategy was applied in electronic databases, and citation tracking was performed. Study selection was performed by 2 independent reviewers according to predefined criteria for eligibility: The intervention was performed preconceptionally on women regarding alcohol use, smoking, weight, diet/nutrition, physical activity, and folic acid status (fortification and supplementation) to achieve behavior change and/or improve pregnancy outcome. Quality and strength of evidence were assessed by 2 independent reviewers. A total of 4,604 potentially relevant records were identified, of which 44 records met the inclusion criteria. Overall, there is a relatively short list of core interventions for which there is substantial evidence of effectiveness when applied in the preconception period.

Design and outline of the Healthy Pregnancy 4 All study.

BACKGROUND: Promotion of healthy pregnancies has gained high priority in the Netherlands because of the relatively unfavourable perinatal health outcomes. In response a nationwide study Healthy Pregnancy 4 All was initiated. This study combines public health and epidemiologic research to evaluate the effectiveness of two obstetric interventions before and during pregnancy: (1) programmatic preconception care (PCC) and (2) systematic antenatal risk assessment (including both medical and non-medical risk factors) followed by patient-tailored multidisciplinary care pathways. In this paper we present an overview of the study setting and outlines. We describe the selection of geographical areas and introduce the design and outline of the preconception care and the antenatal risk assessment studies. METHODS/DESIGN: A thorough analysis was performed to identify geographical areas in which adverse perinatal outcomes were high. These areas were regarded as eligible for either or both sub-studies as we hypothesised studies to have maximal effect there. This selection of municipalities was based on multiple criteria relevant to either the preconception care intervention or the antenatal risk assessment intervention, or to both. The preconception care intervention was designed as a prospective community-based cohort study. The antenatal risk assessment intervention was designed as a cluster randomised controlled trial - where municipalities are randomly allocated to intervention and control. DISCUSSION: Optimal linkage is sought between curative and preventive care, public health, government, and social welfare organisations. To our knowledge, this is the first study in which these elements are combined.

[Best possible start for child and parent]. / Kansrijke start voor kind en ouder.

The health of women during the periconception period and pregnancy is important for a healthy start of the child. All care providers can make a major contribution to this. In this learning article we provide answers to a number of questions that have been collected from the professional field about preconception care and care for vulnerable pregnant women. Our aim is to inform general practitioners and specialists who assist women with a (possible) desire to have children about proactive care in pregnancy, childbirth and child care. Included are concrete actions of the general practitioner when healthy women wish to become pregnant, which medical history and other characteristics of a pregnant woman negatively affects the health of her (unborn) child, and which signals in a first pregnancy predispose for problems after and in a subsequent pregnancy and what role can the GP play in this. Furthermore, we discuss signs of vulnerability in the consulting room, how transmural risk selection can be applied and we provide an overview of interventions applicable in primary care or where to refer to.

Change in Lifestyle Behaviors After Preconception Care: A Prospective Cohort Study.

PURPOSE: To evaluate the effects of preconception care (PCC) consultations by change in lifestyle behaviors. SETTING AND INTERVENTION: Women in deprived neighborhoods of 14 Dutch municipalities were encouraged to visit a general practitioner or midwife for PCC. SAMPLE: The study included women aged 18 to 41 years who had a PCC consultation. DESIGN: In this community-based prospective cohort study, we assessed initiation of folic acid supplementation, cessation of smoking, alcohol consumption, and illicit drug use. MEASURES: Self-reported and biomarker data on behavioral changes were obtained at baseline and 3 months later. ANALYSIS: The changes in prevalence were assessed with the McNemar test. RESULTS: Of the 259 included participants, paired analyses were available in 177 participants for self-reported outcomes and in 82 for biomarker outcomes. Baseline self-reported prevalence of no folic acid use was 36%, smoking 12%, weekly alcohol use 22%, and binge drinking 17%. Significant changes in prevalence toward better lifestyle during follow-up were seen for folic acid use (both self-reported, P < .001; and biomarker-confirmed, P = .008) and for self-reported binge drinking (P = .007). CONCLUSION: Our study suggests that PCC contributes to initiation of folic acid supplementation and cessation of binge drinking in women who intend to become pregnant. Although based on a small sample, the study adds to the limited body of evidence regarding the benefits of PCC in improving periconception health.

Systematic Development of Materials for Inviting Low Health-Literate Individuals to Participate in Preconception Counseling.

In this study we aimed to systematically analyze problems in the recruitment of women with low health literacy for preconception counseling and to adapt and evaluate written invitations for this group. In a problem analysis (stage 1) we used structured interviews (n = 72) to assess comprehension of the initial invitations, perception of perinatal risks, attitude and intention to participate in preconception counseling. These outcomes were used to adapt the invitation. The adapted flyer was pretested in interviews (n = 16) (stage 2) and evaluated in structured interviews among a new group of women (n = 67) (stage 3). Differences between women in stages 1 and 3 regarding comprehension, risk perception, attitude and intention to participate in counseling were analyzed by linear regression analysis and chi-square tests. Women in stage 3 (who read the adapted flyer) had a more positive attitude towards participation in preconception counselling and a better understanding of how to apply for a consultation than women in stage 1 (who read the initial invitations). No differences were found in intention to participate in preconception counseling and risk perception. Systematic adaptation of written invitations can improve the recruitment of low health-literate women for preconception counselling. Further research should gain insight into additional strategies to reach and inform this group.

Analysis of policy towards improvement of perinatal mortality in the Netherlands (2004-2011).

Relatively high perinatal mortality and morbidity rates(2) in the Netherlands resulted in a process which induced policy changes regarding the Dutch perinatal healthcare system. Aims of this policy analysis are (1) to identify actors, context and process factors that promoted or impeded agenda setting and formulation of policy regarding perinatal health care reform and (2) to present an overview of the renewed perinatal health policy. The policy triangle framework for policy analysis by Walt and Gilson was applied(3). Contents of policy, actors, context factors and process factors were identified by triangulation of data from three sources: a document analysis, stakeholder analysis and semi-structured interviews with key stakeholders. Analysis enabled us to chronologically reconstruct the policy process in response to the perinatal mortality rates. The quantification of the perinatal mortality problem, the openness of the debate and the nature of the topic were important process factors. Main theme of policy was that change was required in the entire spectrum of perinatal healthcare. This ranged from care in the preconception phase through to the puerperium. Furthermore emphasis was placed on the importance of preventive measures and socio-environmental determinants of health. This required involvement of the preventive setting, including municipalities. The Dutch tiered perinatal healthcare system and divergent views amongst curative perinatal health care providers were important context factors. This study provides lessons which are applicable to health care professionals and policy makers in perinatal care or other multidisciplinary fields.

Effectiveness of score card-based antenatal risk selection, care pathways, and multidisciplinary consultation in the Healthy Pregnancy 4 All study (HP4ALL): study protocol for a cluster randomized controlled trial.

BACKGROUND: Promotion of healthy pregnancies has gained high priority in the Netherlands because of relatively unfavorable perinatal outcomes. In response, a nationwide study, 'Healthy Pregnancy 4 All' (HP4ALL), has been initiated. Part of this study involves systematic and broadened antenatal risk assessment (the Risk Assessment substudy). Risk selection in current clinical practice is mainly based on medical risk factors. Despite the increasing evidence for the influence of nonmedical risk factors (social status, lifestyle or ethnicity) on perinatal outcomes, these risk factors remain highly unexposed. Systematic risk selection, combined with customized care pathways to reduce or treat detected risks, and regular and structured consultation between community midwives, gynecologists and other care providers such as social workers, is part of this study. METHODS/DESIGN: Neighborhoods in 14 municipalities with adverse perinatal outcomes above national and municipal averages are selected for participation. The study concerns a cluster randomized controlled trial. Municipalities are randomly allocated to intervention (n = 3,500 pregnant women) and control groups (n = 3,500 pregnant women). The intervention consists of systematic risk selection with the Rotterdam Reproductive Risk Reduction (R4U) score card in pregnant women at the booking visit, and referral to corresponding care pathways. A risk score, based on weighed risk factors derived from the R4U, above a predefined threshold determines structured multidisciplinary consultation. Primary outcomes of this trial are dysmaturity (birth weight < p10), prematurity (birth <37 weeks), and efficacy of implementation. DISCUSSION: The 'HP4ALL' study introduces a systematic approach in antenatal health care that may improve perinatal outcomes and, thereby, affect future health status of a new generation in the Netherlands. TRIAL REGISTRATION: Dutch Trial Registry ( NTR-3367) on 20 March 2012.

Effectiveness of general preconception care accompanied by a recruitment approach: protocol of a community-based cohort study (the Healthy Pregnancy 4 All study).

INTRODUCTION: Promotion of healthy pregnancies has gained high priority in the Netherlands because of the relative unfavourable perinatal outcomes. In response, a nationwide study Healthy Pregnancy 4 All (HP4ALL) has been initiated. One of the substudies within HP4ALL focuses on preconception care (PCC). PCC is an opportunity to detect and eliminate risk factors before conception to optimise health before organogenesis and placentation. The main objectives of the PCC substudy are (1) to assess the effectiveness of a recruitment strategy for the PCC health services and (2) to assess the effectiveness of individual PCC consultations. METHODS/ANALYSIS: Prospective cohort study in neighbourhoods of 14 municipalities with perinatal mortality and morbidity rates exceeding the nation's average. The theoretical framework of the PCC substudy is based on Andersen's model of healthcare utilisation (a model that evaluates the utilisation of healthcare services from a sociological perspective). Women aged 18 up to and including 41 years are targeted for utilisation of the PCC health service by a four armed recruitment strategy. The PCC health service consists of an individual PCC consultation consisting of (1) initial risk assessment and risk management and (2) a follow-up consultation to assess adherence to the management plan. The primary outcomes regarding the effectiveness of consultations is behavioural change regarding folic acid supplementation, smoking cessation, cessation of alcohol consumption and illicit substance use. The primary outcome regarding the effectiveness of the recruitment strategy is the number of women successfully recruited and the outreach in terms of which population is reached in comparison to the approached population. Data collection consists of registration in the database of women that enrol for a visit to the individual PCC consultations (women successfully recruited), and preconsultation and postconsultation measurements among the included study population (by questionnaires, anthropometric measurements and biomarkers). Sample size calculation resulted in a sample size of n=839 women. ETHICS AND DISSEMINATION: Approval for this study has been obtained from the Medical Ethical Committee of the Erasmus Medical Center of Rotterdam (MEC 2012-425). Results will be published and presented at international conferences.