Prepregnancy and early pregnancy calcium supplementation among women at high risk of pre-eclampsia: a multicentre, double-blind, randomised, placebo-controlled trial.

BACKGROUND: Reducing deaths from hypertensive disorders of pregnancy is a global priority. Low dietary calcium might account for the high prevalence of pre-eclampsia and eclampsia in low-income countries. Calcium supplementation in the second half of pregnancy is known to reduce the serious consequences of pre-eclampsia; however, the effect of calcium supplementation during placentation is not known. We aimed to test the hypothesis that calcium supplementation before and in early pregnancy (up to 20 weeks' gestation) prevents the development of pre-eclampsia METHODS: We did a multicountry, parallel arm, double-blind, randomised, placebo-controlled trial in South Africa, Zimbabwe, and Argentina. Participants with previous pre-eclampsia and eclampsia received 500 mg calcium or placebo daily from enrolment prepregnancy until 20 weeks' gestation. Participants were parous women whose most recent pregnancy had been complicated by pre-eclampsia or eclampsia and who were intending to become pregnant. All participants received unblinded calcium 1·5 g daily after 20 weeks' gestation. The allocation sequence (1:1 ratio) used computer-generated random numbers in balanced blocks of variable size. The primary outcome was pre-eclampsia, defined as gestational hypertension and proteinuria. The trial is registered with the Pan-African Clinical Trials Registry, number PACTR201105000267371. The trial closed on Oct 31, 2017. FINDINGS: Between July 12, 2011, and Sept 8, 2016, we randomly allocated 1355 women to receive calcium or placebo; 331 of 678 participants in the calcium group versus 320 of 677 in the placebo group became pregnant, and 298 of 678 versus 283 of 677 had pregnancies beyond 20 weeks' gestation. Pre-eclampsia occurred in 69 (23%) of 296 participants in the calcium group versus 82 (29%) of 283 participants in the placebo group with pregnancies beyond 20 weeks' gestation (risk ratio [RR] 0·80, 95% CI 0·61-1·06; p=0·121). For participants with compliance of more than 80% from the last visit before pregnancy to 20 weeks' gestation, the pre-eclampsia risk was 30 (21%) of 144 versus 47 (32%) of 149 (RR 0·66, CI 0·44-0·98; p=0·037). There were no serious adverse effects of calcium reported. INTERPRETATION: Calcium supplementation that commenced before pregnancy until 20 weeks' gestation, compared with placebo, did not show a significant reduction in recurrent pre-eclampsia. As the trial was powered to detect a large effect size, we cannot rule out a small to moderate effect of this intervention. FUNDING: The University of British Columbia, a grantee of the Bill & Melinda Gates Foundation; UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction, WHO; the Argentina Fund for Horizontal Cooperation of the Argentinean Ministry of Foreign Affairs; and the Centre for Intervention Science in Maternal and Child Health.

Are women with history of pre-eclampsia starting a new pregnancy in good nutritional status in South Africa and Zimbabwe?

BACKGROUND: Maternal nutritional status before and during pregnancy is an important contributor to pregnancy outcomes and early child health. The aim of this study was to describe the preconceptional nutritional status and dietary intake during pregnancy in high-risk women from South Africa and Zimbabwe. METHODS: This is a prospective observational study, nested to the CAP trial. Anthropometric measurements before and during pregnancy and dietary intake using 24-h recall during pregnancy were assessed. The Intake Distribution Estimation software (PC-SIDE) was used to evaluate nutrient intake adequacy taking the Estimated Average Requirement (EAR) as a cut-off point. RESULTS: Three hundred twelve women who had pre-eclampsia in their last pregnancy and delivered in hospitals from South Africa and Zimbabwe were assessed. 73.7 and 60.2% women in South Africa and Zimbabwe, respectively started their pregnancy with BMI above normal (BMI ≥ 25) whereas the prevalence of underweight was virtually non-existent. The majority of women had inadequate intakes of micronutrients. Considering food and beverage intake only, none of the micronutrients measured achieved the estimated average requirement. Around 60% of pregnant women reported taking folic acid or iron supplements in South Africa, but almost none did so in Zimbabwe. CONCLUSION: We found a high prevalence of overweight and obesity and high micronutrient intake inadequacy in pregnant women who had the previous pregnancy complicated with pre-eclampsia. The obesity figures and micronutrient inadequacy are issues of concern that need to be addressed. Pregnant women have regular contacts with the health system; these opportunities could be used to improve diet and nutrition. TRIAL REGISTRATION: PACTR201105000267371 . Registered 06 December 2010.

Participatory action research to identify a package of interventions to promote postpartum family planning in Burkina Faso and the Democratic Republic of Congo.

BACKGROUND: The YAM DAABO study ("your choice" in Mooré) takes place in Burkina Faso and the Democratic Republic of Congo. It has the objective to identify a package of postpartum family planning (PPFP) interventions to strengthen primary healthcare services and determine its effectiveness on contraceptive uptake during the first year postpartum. This article presents the process of identifying the PPFP interventions and its detailed contents. METHODS: Based on participatory action research principles, we adopted an inclusive process with two complementary approaches: a bottom-up formative approach and a circular reflective approach, both of which involved a wide range of stakeholders. For the bottom-up component, we worked in each country in three formative sites and used qualitative methods to identify barriers and catalysts to PPFP uptake. The results informed the package design which occurred during the circular reflective approach - a research workshop gathering service providers, members of both country research teams, and the WHO coordination team. RESULTS: As barriers and catalysts were found to be similar in both countries and with the view to scaling up our strategy to other comparable settings, we identified a common package of six low-cost, low-technology, and easily-scalable interventions that addressed the main service delivery obstacles related to PPFP: (1) refresher training of service providers, (2) regularly scheduled and strengthened supportive supervision of service providers, (3) enhanced availability of services 7 days a week, (4) a counseling tool, (5) appointment cards for women, and (6) invitation letters for partners. CONCLUSIONS: Our research strategy assumes that postpartum contraceptive uptake can be increased by supporting providers, enhancing the availability of services, and engaging women and their partners. The package does not promote any modern contraceptive method over another but prioritizes the importance of women's right to information and choice regarding postpartum fertility options. The effectiveness of the package will be studied in the experimental phase. If found to be effective, this intervention package may be relevant to and scalable in other parts of Burkina Faso and the DRC, and possibly other Sub-Saharan countries. TRIAL REGISTRATION: Retrospectively registered in the Pan African Clinical Trials Registry ( PACTR201609001784334 , 27 September 2016).

Effectiveness of a package of postpartum family planning interventions on the uptake of contraceptive methods until twelve months postpartum in Burkina Faso and the Democratic Republic of Congo: the YAM DAABO study protocol.

BACKGROUND: Postpartum family planning (PPFP) information and services can prevent maternal and child morbidity and mortality in low-resource countries, where high unmet need for PPFP remains despite opportunities offered by routine postnatal care visits. This study aims to identify a package of PPFP interventions and determine its effectiveness on the uptake of contraceptive methods during the first year postpartum. We hypothesize that implementing a PPFP intervention package that is designed to strengthen existing antenatal and postnatal care services will result in an increase in contraceptive use. METHODS: This is an operational research project using a complex intervention design with three interacting phases. The pre-formative phase aims to map study sites to establish a sampling frame. The formative phase employs a participatory approach using qualitative methodology to identify barriers and catalysts to PPFP uptake to inform the design of a PPFP intervention package. The intervention phase applies a cluster randomized-controlled trial design based at the primary healthcare level, with the experimental group implementing the PPFP package, and the control group implementing usual care. The primary outcome is modern contraceptive method uptake at twelve months postpartum. Qualitative research is embedded in the intervention phase to understand the operational reasons for success or failure of PPFP services. DISCUSSION: Designing, testing, and scaling-up effective, affordable, and sustainable health interventions in low-resource countries is critical to address the high unmet need for PPFP. Due to socio-cultural complexities surrounding contraceptive use, this research assumes that this is more effectively accomplished by engaging key stakeholders, including adolescents, women, men, key community members, service providers, and policy-makers. At the individual level, knowledge, attitudes, and behaviors of women and couples toward PPFP will likely be influenced by a set of low-cost interventions. At the health service delivery level, the implementation of this trial will probably require a shift in behavior and accountability of providers regarding the systematic integration of PPFP into their clinical practice, as well as the optimization of health service organization to ensure the availability of competent staff and contraceptive supplies. TRIAL REGISTRATION: Retrospectively registered in the Pan African Clinical Trials Registry ( PACTR201609001784334 , 27 September 2016).

Breakdown of simple female genital fistula repair after 7 day versus 14 day postoperative bladder catheterisation: a randomised, controlled, open-label, non-inferiority trial.

BACKGROUND: Duration of bladder catheterisation after female genital fistula repair varies widely. We aimed to establish whether 7 day bladder catheterisation was non-inferior to 14 days in terms of incidence of fistula repair breakdown in women with simple fistula. METHODS: In this randomised, controlled, open-label, non-inferiority trial, we enrolled patients at eight hospitals in the Democratic Republic of the Congo, Ethiopia, Guinea, Kenya, Niger, Nigeria, Sierra Leone, and Uganda. Consenting patients were eligible if they had a simple fistula that was closed after surgery and remained closed 7 days after surgery, understood study procedures and requirements, and agreed to return for follow-up 3 months after surgery. We excluded women if their fistula was not simple or was radiation-induced, associated with cancer, or due to lymphogranuloma venereum; if they were pregnant; or if they had multiple fistula. A research assistant at each site randomly allocated participants 1:1 (randomly varying block sizes of 4-6; stratified by country) to 7 day or 14 day bladder catheterisation (via a random allocation sequence computer generated centrally by WHO). Outcome assessors were not masked to treatment assignment. The primary outcome was fistula repair breakdown, on the basis of dye test results, any time between 8 days after catheter removal and 3 months after surgery. The non-inferiority margin was 10%, assessed in the per-protocol population. This trial is registered with ClinicalTrials.gov, number NCT01428830. FINDINGS: We randomly allocated 524 participants between March 7, 2012, and May 6, 2013; 261 in the 7 day group and 263 in the 14 day group. In the per-protocol analysis, ten (4%) of 250 patients had repair breakdown in the 7 day group (95% CI 2-8) compared with eight (3%) of 251 (2-6) in the 14 day group (risk difference 0·8% [95% CI -2·8 to 4·5]), meeting the criteria for non-inferiority. INTERPRETATION: 7 day bladder catheterisation after repair of simple fistula is non-inferior to 14 day catheterisation and could be used for management of women after repair of simple fistula with no evidence of a significantly increased risk of repair breakdown, urinary retention, or residual incontinence up to 3 months after surgery. FUNDING: US Agency for International Development.

Episiotomy and obstetric outcomes among women living with type 3 female genital mutilation: a secondary analysis.

BACKGROUND: To investigate the association between type of episiotomy and obstetric outcomes among 6,187 women with type 3 Female Genital Mutilation (FGM). METHODS: We conducted a secondary analysis of women presenting in labor to 28 obstetric centres in Burkina Faso, Ghana, Kenya, Nigeria, Senegal and Sudan between November 2001 and March 2003. Data were analysed using cross tabulations and multivariable logistic regression to determine if type of episiotomy by FGM classification had a significant impact on key maternal outcomes. Our main outcome measures were anal sphincter tears, intrapartum blood loss requiring an intervention, and postpartum haemorrhage. RESULTS: Type of episiotomy performed varied significantly by FGM status. Among women without FGM, the most common type of episiotomy performed was posterior lateral (25.4 %). The prevalence of the most extensive type of episiotomy, anterior and posterior lateral episiotomy increased with type of FGM. Among women without FGM, 0.4 % had this type of episiotomy. This increased to 0.6 % for women with FGM Types 1, 2 or 4 and to 54.6 % of all women delivering vaginally with FGM Type 3. After adjustment, women with an anterior episiotomy, (AOR = 0.15 95 %; CI 0.06-0.40); posterior lateral episiotomy (AOR = 0.68 95 %; CI 0.50-0.94) or both anterior and posterior lateral episiotomies performed concurrently (AOR = 0.21 95 % CI 0.12-0.36) were all significantly less likely to have anal sphincter tears compared to women without episiotomies. Women with anterior episiotomy (AOR = 0.08; 95%CI 0.02-0.24), posterior lateral episiotomy (AOR = 0.17 95 %; CI 0.05-0.52) and the combination of the two (AOR = 0.04 95 % CI 0.01-0.11) were significantly less likely to have postpartum haemorrhage compared with women who had no episiotomy. CONCLUSIONS: Among women living with FGM Type 3, episiotomies were protective against anal sphincter tears and postpartum haemorrhage. Further clinical and research is needed to guide clinical practice of when episiotomies should be performed.

Global, regional and national levels and trends of preterm birth rates for 1990 to 2014: protocol for development of World Health Organization estimates.

BACKGROUND: The official WHO estimates of preterm birth are an essential global resource for assessing the burden of preterm birth and developing public health programmes and policies. This protocol describes the methods that will be used to identify, critically appraise and analyse all eligible preterm birth data, in order to develop global, regional and national level estimates of levels and trends in preterm birth rates for the period 1990 - 2014. METHODS: We will conduct a systematic review of civil registration and vital statistics (CRVS) data on preterm birth for all WHO Member States, via national Ministries of Health and Statistics Offices. For Member States with absent, limited or lower-quality CRVS data, a systematic review of surveys and/or research studies will be conducted. Modelling will be used to develop country, regional and global rates for 2014, with time trends for Member States where sufficient data are available. Member States will be invited to review the methodology and provide additional eligible data via a country consultation before final estimates are developed and disseminated. DISCUSSION: This research will be used to generate estimates on the burden of preterm birth globally for 1990 to 2014. We invite feedback on the methodology described, and call on the public health community to submit pertinent data for consideration. TRIAL REGISTRATION: Registered at PROSPERO CRD42015027439 CONTACT: pretermbirth@who.int.

Nurse versus physician-provision of early medical abortion in Mexico: a randomized controlled non-inferiority trial.

OBJECTIVE: To examine the effectiveness, safety, and acceptability of nurse provision of early medical abortion compared to physicians at three facilities in Mexico City. METHODS: We conducted a randomized non-inferiority trial on the provision of medical abortion and contraceptive counselling by physicians or nurses. The participants were pregnant women seeking abortion at a gestational duration of 70 days or less. The medical abortion regimen was 200 mg of oral mifepristone taken on-site followed by 800 µg of misoprostol self-administered buccally at home 24 hours later. Women were instructed to return to the clinic for follow-up 7-15 days later. We did an intention-to-treat analysis for risk differences between physicians' and nurses' provision for completion and the need for surgical intervention. FINDINGS: Of 1017 eligible women, 884 women were included in the intention-to-treat analysis, 450 in the physician-provision arm and 434 in the nurse-provision arm. Women who completed medical abortion, without the need for surgical intervention, were 98.4% (443/450) for physicians' provision and 97.9% (425/434) for nurses' provision. The risk difference between the group was 0.5% (95% confidence interval, CI: -1.2% to 2.3%). There were no differences between providers for examined gestational duration or women's contraceptive method uptake. Both types of providers were rated by the women as highly acceptable. CONCLUSION: Nurses' provision of medical abortion is as safe, acceptable and effective as provision by physicians in this setting. Authorizing nurses to provide medical abortion can help to meet the demand for safe abortion services.

A multicentre randomized controlled trial of gentle assisted pushing in the upright posture (GAP) or upright posture alone compared with routine practice to reduce prolonged second stage of labour (the Gentle Assisted Pushing study): study protocol.

BACKGROUND: Fundal pressure (pushing on the upper part of the uterus in the direction of the birth canal) is often performed in routine practice, however the benefit and indications for its use are unclear and vigorous pressure is potentially harmful. There is some evidence that it may be applied routinely or to expedite delivery in some situations (e.g. fetal distress or maternal exhaustion), particularly in settings where other methods of achieving delivery (forceps, vacuum) are not available. Gentle assisted pushing (GAP) is an innovative method of applying gentle but steady pressure to the uterine fundus with the woman in an upright posture. This trial aims to evaluate the use of GAP in an upright posture, or upright posture alone, on reducing the mean time of delivery and the associated maternal and neonatal complications in women not having delivered following 15-30 min in the second stage of labour. METHODS/DESIGN: We will conduct a multicentre, randomized, unblinded, controlled trial with three parallel arms (1:1:1). 1,145 women will be randomized at three hospitals in South Africa. Women will be eligible for inclusion if they are ≥18 years old, nulliparous, gestational age ≥ 35 weeks, have a singleton pregnancy in cephalic presentation and vaginal delivery anticipated. Women with chronic medical conditions or obstetric complications are not eligible. If eligible women are undelivered following 15-30 min in the second stage of labour, they will be randomly assigned to: 1) GAP in the upright posture, 2) upright posture only and 3) routine practice (recumbent/supine posture). The primary outcome is the mean time from randomization to complete delivery. Secondary outcomes include operative delivery, adverse neonatal outcomes, maternal adverse events and discomfort. DISCUSSION: This trial will establish whether upright posture and/or a controlled method of applying fundal pressure (GAP) can improve labour outcomes for women and their babies. If fundal pressure is found to have a measurable beneficial effect, this gentle approach can be promoted as a replacement for the uncontrolled methods currently in use. If it is not found to be useful, fundal pressure can be discouraged.

Age at natural menopause among patients with systemic lupus erythematosus.

OBJECTIVE: The aim of this study was to estimate the age at natural menopause in women with SLE. METHODS: One thousand and thirty-nine consecutive SLE patients <60 years of age were surveyed. Demographic and clinical data were queried by a single investigator. SLE characteristics and co-morbidities were retrieved from their medical records. Natural menopause was defined as amenorrhoea ≥12 months in the absence of previous hysterectomy, CYC exposure and severe chronic kidney disease (SCKD). Pregnant women and those with menses during the 12 months prior to interview were considered premenopausal. Median age at menopause was estimated by both logit and survival analyses. In addition, mean age at menopause was calculated for patients aged ≥40 years. Factors associated with age at natural menopause were assessed by Cox regression analysis. RESULTS: A total of 961 SLE women were analysed. At interview, most patients (81.6%) were premenopausal, 7.9% had natural menopause, 6.3% were postmenopausal previously exposed to CYC, 4.1% had undergone hysterectomy before menopause and 0.1% presented with SCKD and amenorrhoea. The mean age at interview was 35.2 years (s.d. 10.1), the mean age at SLE diagnosis was 26.9 years (s.d. 8.6) and the mean duration of disease was 8.2 years (s.d. 7.1). The mean recalled age at menopause was 46.4 years (s.d. 4.7). Median age at menopause estimated by logit and survival analyses were 50.7 and 50.8 years, respectively. Only the age at SLE diagnosis was associated with age at natural menopause. CONCLUSION: Median age at natural menopause in women with lupus is 50 years. This is consistent with the age at menopause reported in the general population.

A global research agenda for family planning: results of an exercise for setting research priorities.

OBJECTIVE: To develop a global research agenda that will guide investment in effective interventions to satisfy the large unmet need for modern methods of family planning. METHODS: In a global survey, experts on contraception were invited to identify and rank the types of research that would be needed--and the knowledge gaps that would have to be filled--to reduce the unmet need for family planning in the next decade. The experts were then asked to score the research on a given topic in terms of the likelihood of its leading to an intervention that would: (i) be deliverable, affordable and sustainable; (ii) substantially reduce the unmet need for contraceptives; (iii) be effective and efficient in improving health systems; (iv) be ethically implemented; and (v) improve equity in the target population. The overall scores were then ranked. FINDINGS: Most of the topics that received the 15 highest scores fell into three categories: implementation of policies in family planning; the integration of services to address barriers to contraceptive use; and interventions targeted at underserved groups, such as adolescents. CONCLUSION: Experts on contraception gave top priority ranking to research on improving the implementation and integration of health services and on strengthening the health systems supporting family planning services. The results of the exercise may help decision-makers, researchers and funding agencies to develop a clear and focused approach to satisfying the global need for family planning and reach the target set by the Family Planning 2020 initiative.

Seeking what matters: determinants of clients' satisfaction in obstetric care services in Pakistan.

BACKGROUND: Aim of this study was to determine the dimensions of the service quality in the public hospitals and evaluate the determinants of client satisfaction in obstetric health in the context of Pakistan. METHODS: The present research evaluates the application of an integrated client satisfaction model that draws mainly from the original SERVQUAL framework in obstetric health services. We conducted a cross-sectional study, in four public district hospitals in Pakistan, enrolling 1101 clients attending obstetric health care services. Measures of service quality and determinants of client satisfaction were factor-analysed and multiple regression analysis was used to test the hypothesis. RESULTS: The client satisfaction increased significantly with increases in respondent's age, number of children, number of visits and with decrease in educational status. Factor analysis revealed five service quality dimensions; and multiple regression analysis showed that all five dimensions of service quality in obstetric care were significant in explaining client satisfaction. The most powerful predictor for client satisfaction was provider communication with clients, followed by responsiveness and discipline. CONCLUSIONS: Interventions aimed at improving client provider interaction would not only advance the clinical provision of services, butwould also result in greater patient satisfaction with the services provided, leading to higher levels of facility utilization and continuity of care. Better client provider interaction can be accomplished at hospital's level through focused training of all cadre of service providers sensitizing them on clients' needs. Results also showed that the proposed framework is a valid and flexible instrument in assessing and monitoring service quality and enabling staff to identify where improvements are needed, from the clients' perspective.

Strengthening contraceptive counselling services to empower clients and meet their needs: protocol for a two-stage, multiphase complex intervention in Pakistan and Nigeria.

BACKGROUND: High-quality contraceptive counselling can accelerate global efforts to reduce the unmet need for and suboptimal use of modern contraceptives. This study aims to identify a package of interventions designed to strengthen in Pakistan and Nigeria and determine their effectiveness in increasing client-level decision-making, autonomy and meeting of contraceptive needs. METHODS: A multisite, two-stage and five-phase intervention design will start with a pre-formative, formative, design, experimental and reflective phase. The pre-formative phase will map potential study sites and establish the sampling frame. The two-part formative phase will first use participatory approaches to identify clients' perspectives, including young couples and providers, to ensure research contextualisation and address each interest group's needs and priorities followed by clinical observations of client-provider encounters to document routine care. The design workshop in the third phase will result in the development of a package of contraceptive counselling interventions. In the fourth experimental phase, a multi-intervention, three-arm, single-blinded, parallel cluster randomised-controlled trial will compare routine care (arm 1) with the contraceptive counselling package (arm 2) and the same package combined with wider methods availability (arm 3). The study aims to enrol a total of 7920 participants. The reflective phase aims to identify implementation barriers and enablers. The outcomes are clients' level of decision-making autonomy and use of modern contraceptives. ETHICS AND DISSEMINATION: Ethical approval for this study was obtained from the WHO Scientific and Ethics Review Committee (Protocol ID Pakistan: ERC 006232 and Nigeria ERC: 006523). Each study site is required and has obtained the necessary ethical and regulatory approvals that are required in each specific country. Findings will be presented at local, national and international conferences and disseminated by peer-review publications. TRIAL REGISTRATION NUMBER: NCT06081842.

Viral shedding of SARS-CoV-2 in body fluids associated with sexual activity: a systematic review and meta-analysis.

OBJECTIVE: To identify and summarise the evidence on the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA detection and persistence in body fluids associated with sexual activity (saliva, semen, vaginal secretion, urine and faeces/rectal secretion). ELIGIBILITY: All studies that reported detection of SARS-CoV-2 in saliva, semen, vaginal secretion, urine and faeces/rectal swabs. INFORMATION SOURCES: The WHO COVID-19 database from inception to 20 April 2022. RISK OF BIAS ASSESSMENT: The National Institutes of Health tools. SYNTHESIS OF RESULTS: The proportion of patients with positive results for SARS-CoV-2 and the proportion of patients with a viral duration/persistence of at least 14 days in each fluid was calculated using fixed or random effects models. INCLUDED STUDIES: A total of 182 studies with 10 023 participants. RESULTS: The combined proportion of individuals with detection of SARS-CoV-2 was 82.6% (95% CI: 68.8% to 91.0%) in saliva, 1.6% (95% CI: 0.9% to 2.6%) in semen, 2.7% (95% CI: 1.8% to 4.0%) in vaginal secretion, 3.8% (95% CI: 1.9% to 7.6%) in urine and 31.8% (95% CI: 26.4% to 37.7%) in faeces/rectal swabs. The maximum viral persistence for faeces/rectal secretions was 210 days, followed by semen 121 days, saliva 112 days, urine 77 days and vaginal secretions 13 days. Culturable SARS-CoV-2 was positive for saliva and faeces. LIMITATIONS: Scarcity of longitudinal studies with follow-up until negative results. INTERPRETATION: SARS-CoV-2 RNA was detected in all fluids associated with sexual activity but was rare in semen and vaginal secretions. Ongoing droplet precautions and awareness of the potential risk of contact with faecal matter/rectal mucosa are needed. PROSPERO REGISTRATION NUMBER: CRD42020204741.

Global estimates of syphilis in pregnancy and associated adverse outcomes: analysis of multinational antenatal surveillance data.

BACKGROUND: The World Health Organization initiative to eliminate mother-to-child transmission of syphilis aims for ≥ 90% of pregnant women to be tested for syphilis and ≥ 90% to receive treatment by 2015. We calculated global and regional estimates of syphilis in pregnancy and associated adverse outcomes for 2008, as well as antenatal care (ANC) coverage for women with syphilis. METHODS AND FINDINGS: Estimates were based upon a health service delivery model. National syphilis seropositivity data from 97 of 193 countries and ANC coverage from 147 countries were obtained from World Health Organization databases. Proportions of adverse outcomes and effectiveness of screening and treatment were from published literature. Regional estimates of ANC syphilis testing and treatment were examined through sensitivity analysis. In 2008, approximately 1.36 million (range: 1.16 to 1.56 million) pregnant women globally were estimated to have probable active syphilis; of these, 80% had attended ANC. Globally, 520,905 (best case: 425,847; worst case: 615,963) adverse outcomes were estimated to be caused by maternal syphilis, including approximately 212,327 (174,938; 249,716) stillbirths (>28 wk) or early fetal deaths (22 to 28 wk), 91,764 (76,141; 107,397) neonatal deaths, 65,267 (56,929; 73,605) preterm or low birth weight infants, and 151,547 (117,848; 185,245) infected newborns. Approximately 66% of adverse outcomes occurred in ANC attendees who were not tested or were not treated for syphilis. In 2008, based on the middle case scenario, clinical services likely averted 26% of all adverse outcomes. Limitations include missing syphilis seropositivity data for many countries in Europe, the Mediterranean, and North America, and use of estimates for the proportion of syphilis that was "probable active," and for testing and treatment coverage. CONCLUSIONS: Syphilis continues to affect large numbers of pregnant women, causing substantial perinatal morbidity and mortality that could be prevented by early testing and treatment. In this analysis, most adverse outcomes occurred among women who attended ANC but were not tested or treated for syphilis, highlighting the need to improve the quality of ANC as well as ANC coverage. In addition, improved ANC data on syphilis testing coverage, positivity, and treatment are needed. Please see later in the article for the Editors' Summary.

Do Italian women prefer cesarean section? Results from a survey on mode of delivery preferences.

BACKGROUND: About 20 million cesareans occur each year in the world and rates have steadily increased in almost all middle- and high-income countries over the last decades. Maternal request is often argued as one of the key forces driving this increase. Italy has the highest cesarean rate of Europe, yet there are no national surveys on the views of Italian women about their preferences on route of delivery. This study aimed to assess Italian women's preference for mode of delivery, as well as reasons and factors associated with this preference, in a nationally representative sample of women. METHODS: This cross sectional survey was conducted between December 2010-March 2011. An anonymous structured questionnaire asked participants what was their preferred mode of delivery and explored the reasons for this preference by assessing their agreement to a series of statements. Participants were also asked to what extent their preference was influenced by a series of possible sources. The 1st phase of the study was carried out among readers of a popular Italian women's magazine (Io Donna). In a 2nd phase, the study was complemented by a structured telephone interview. RESULTS: A total of 1000 Italian women participated in the survey and 80% declared they would prefer to deliver vaginally if they could opt. The preference for vaginal delivery was significantly higher among older (84.7%), more educated (87.6%), multiparous women (82.3%) and especially among those without any previous cesareans (94.2%). The main reasons for preferring a vaginal delivery were not wanting to be separated from the baby during the first hours of life, a shorter hospital stay and a faster postpartum recovery. The main reasons for preferring a cesarean were fear of pain, convenience to schedule the delivery and because it was perceived as being less traumatic for the baby. The source which most influenced the preference of these Italian women was their obstetrician, followed by friends or relatives. CONCLUSION: Four in five Italian women would prefer to deliver vaginally if they could opt. Factors associated with a higher preference for cesarean delivery were youth, nulliparity, lower education and a previous cesarean.

Role of faith-based and nongovernment organizations in the provision of obstetric services in 3 African countries.

OBJECTIVE: We sought to describe obstetric care capacity of nongovernment organization (NGO)-/faith-based organization (FBO)-run institutions compared to government-run institutions in 3 African countries using the World Health Organization Global Survey. We also compared delivery characteristics and outcomes. STUDY DESIGN: This is a descriptive analysis of the 22 NGO-/FBO-run institutions in Uganda, Kenya and Democratic Republic of Congo delivering 11,594 women, compared to 20 government-run institutions delivering 25,825 women in the same countries and period. RESULTS: Infrastructure, obstetric services, diagnostic facilities, and anesthesiology at NGO/FBO institutions were comparable to government institutions. Women delivering at NGO/FBO institutions had more antenatal care, antenatal complications, and cesarean delivery. NGO/FBO institutions had higher obstetrician attendance and lower rates of eclampsia, preterm birth, stillbirth, Apgar <7, and neonatal near miss. CONCLUSION: NGO/FBO institutions are comparable to government institutions in capacity to deliver obstetric care. NGO/FBOs have been found effective in providing delivery care in developing countries and should be appropriately recognized by stakeholders in their efforts to assist nations achieve international goals.

Non-inferiority of short-term urethral catheterization following fistula repair surgery: study protocol for a randomized controlled trial.

BACKGROUND: A vaginal fistula is a devastating condition, affecting an estimated 2 million girls and women across Africa and Asia. There are numerous challenges associated with providing fistula repair services in developing countries, including limited availability of operating rooms, equipment, surgeons with specialized skills, and funding from local or international donors to support surgeries and subsequent post-operative care. Finding ways of providing services in a more efficient and cost-effective manner, without compromising surgical outcomes and the overall health of the patient, is paramount. Shortening the duration of urethral catheterization following fistula repair surgery would increase treatment capacity, lower costs of services, and potentially lower risk of healthcare-associated infections among fistula patients. There is a lack of empirical evidence supporting any particular length of time for urethral catheterization following fistula repair surgery. This study will examine whether short-term (7 day) urethral catheterization is not worse by more than a minimal relevant difference to longer-term (14 day) urethral catheterization in terms of incidence of fistula repair breakdown among women with simple fistula presenting at study sites for fistula repair service. METHODS/DESIGN: This study is a facility-based, multicenter, non-inferiority randomized controlled trial (RCT) comparing the new proposed short-term (7 day) urethral catheterization to longer-term (14 day) urethral catheterization in terms of predicting fistula repair breakdown. The primary outcome is fistula repair breakdown up to three months following fistula repair surgery as assessed by a urinary dye test. Secondary outcomes will include repair breakdown one week following catheter removal, intermittent catheterization due to urinary retention and the occurrence of septic or febrile episodes, prolonged hospitalization for medical reasons, catheter blockage, and self-reported residual incontinence. This trial will be conducted among 512 women with simple fistula presenting at 8 study sites for fistula repair surgery over the course of 24 months at each site. DISCUSSION: If no major safety issues are identified, the data from this trial may facilitate adoption of short-term urethral catheterization following repair of simple fistula in sub-Saharan Africa and Asia. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT01428830.

Health systems analysis and evaluation of the barriers to availability, utilisation and readiness of sexual and reproductive health services in COVID-19-affected areas: a WHO mixed-methods study protocol.

INTRODUCTION: COVID-19 has led to an unprecedented increase in demand on health systems to care for people infected, necessitating the allocation of significant resources, especially medical resources, towards the response. This, compounded by the restrictions on movement instituted may have led to disruptions in the provision of essential services, including sexual and reproductive health (SRH) services. This study aims to assess the availability of contraception, comprehensive abortion care, sexually transmitted infection prevention and treatment and sexual and gender-based violence care and support services in local health facilities during COVID-19 pandemic. This is a standardised generic protocol designed for use across different global settings. METHODS AND ANALYSIS: This study adopts both quantitative and qualitative methods to assess health facilities' SRH service availability and readiness, and clients' and providers' perceptions of the availability and readiness of these services in COVID-19-affected areas. The study has two levels: (1) perceptions of clients (and the partners) and healthcare providers, using qualitative methods, and (2) assessment of infrastructure availability and readiness to provide SRH services through reviews, facility service statistics for clients and a qualitative survey for healthcare provider perspectives. The health system assessment will use a cross-sectional panel survey design with two data collection points to capture changes in SRH services availability as a result of the COVID-19 epidemic. Data will be collected using focus group discussions, in-depth interviews and a health facility assessment survey. ETHICS AND DISSEMINATION: Ethical approval for this study was obtained from the WHO Scientific and Ethics Review Committee (protocol ID CERC.0103). Each study site is required to obtain the necessary ethical and regulatory approvals that are required in each specific country.

Sexual behaviour patterns and STI risk: results of a cluster analysis among men who have sex with men in Portugal.

OBJECTIVES: Portugal has the highest HIV incidence rate in Western Europe. The proportion assigned to sexual contact between men recently increased to more than 30% of all HIV infections. Men who have sex with men (MSM) are vulnerable to the acquisition of other sexually transmitted infections (STIs), increasing the per-contact risk of HIV infection. Building on syndemic theory, the aim of this analysis was to identify patterns of current sexual behaviour in MSM, and explore their relationship with self-reported current, past STI diagnoses and HIV positive serostatus. DESIGN: A cross-sectional behavioural survey was conducted in Portugal among MSM, using a community-based participatory research approach. Hierarchical cluster analysis was used to identify patterns including behavioural and demographic factors. RESULTS: The analysis resulted in six clusters. Three clusters showed higher rates of current STI diagnosis (ranging from 11.7% to 17.1%), past STI diagnosis (ranging from 25.5% to 41.5%) and HIV positive serostatus (ranging from 13.0% to 16.7%). From the three clusters scoring lower on current and past STI and HIV diagnoses, one was characterised by a high number of sexual partners (62% had more than 12 partners in the last year), a high proportion (94.6%) of frequent visits to gay venues to meet sexual partners and high alcohol use (46.1%). The other two clusters scored lower on high risk sexual behaviour. CONCLUSION: Factors other than sexual behaviour appear to reinforce the vulnerability to STIs and HIV of some MSM in this study, suggesting a syndemic of STIs, HIV and other adverse conditions. More research is needed to better understand the drivers of the STI/HIV epidemic in Portuguese MSM, using a concept that goes beyond risk behaviour, to develop effective combination prevention interventions.