Point-of-care testing and treatment of sexually transmitted and genital infections to improve birth outcomes in high-burden, low-resource settings (WANTAIM): a pragmatic cluster randomised crossover trial in Papua New Guinea.

BACKGROUND: Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and bacterial vaginosis have been associated with adverse maternal and perinatal outcomes, but there is conflicting evidence on the benefits of antenatal screening and treatment for these conditions. We aimed to determine the effect of antenatal point-of-care testing and immediate treatment of C trachomatis, N gonorrhoeae, T vaginalis, and bacterial vaginosis on preterm birth, low birthweight, and other adverse maternal and perinatal outcomes compared with current standard of care, which included symptom-based treatment without laboratory confirmation. METHODS: In this pragmatic cluster randomised crossover trial, we enrolled women (aged ≥16 years) attending an antenatal clinic at 26 weeks' gestation or earlier (confirmed by obstetric ultrasound), living within approximately 1 h drive of a study clinic, and able to provide reliable contact details at ten primary health facilities and their catchment communities (clusters) in Papua New Guinea. Clusters were randomly allocated 1:1 to receive either the intervention or control (standard care) in the first phase of the trial. Following an interval (washout period) of 2-3 months at the end of the first phase, each cluster crossed over to the other group. Randomisation was stratified by province. Individual participants were informed about trial group allocation only after completing informed consent procedures. The primary outcome was a composite of preterm birth (livebirth before 37 weeks' gestation), low birthweight (<2500 g), or both, analysed according to the intention-to-treat population. This study is registered with ISRCTN Registry, ISRCTN37134032, and is completed. FINDINGS: Between July 26, 2017, and Aug 30, 2021, 4526 women were enrolled (2210 [63·3%] of 3492 women in the intervention group and 2316 [62·8%] of 3687 in the control group). Primary outcome data were available for 4297 (94·9%) newborn babies of 4526 women. The proportion of preterm birth, low birthweight, or both, in the intervention group, expressed as the mean of crude proportions across clusters, was 18·8% (SD 4·7%) compared with 17·8% in the control group (risk ratio [RR] 1·06, 95% CI 0·78-1·42; p=0·67). There were 1052 serious adverse events reported (566 in the intervention group and 486 in the control group) among 929 trial participants, and no differences by trial group. INTERPRETATION: Point-of-care testing and treatment of C trachomatis, N gonorrhoeae, T vaginalis, and bacterial vaginosis did not reduce preterm birth or low birthweight compared with standard care. Within the subgroup of women with N gonorrhoeae, there was a substantial reduction in the primary outcome. FUNDING: UK Department of Health and Social Care; UK Foreign, Commonwealth and Development Office; UK Medical Research Council; the Wellcome Trust; the Australian National Health and Medical Research Council; and Swiss National Science Foundation.

Community perspectives and experiences of quality maternal and newborn care in East New Britain, Papua New Guinea.

BACKGROUND: Quality maternal and newborn care is essential for improving the health of mothers and babies. Low- and middle-income countries, such as Papua New Guinea (PNG), face many barriers to achieving quality care for all. Efforts to improve the quality of maternal and newborn care must involve community in the design, implementation, and evaluation of initiatives to ensure that interventions are appropriate and relevant for the target community. We aimed to describe community members' perspectives and experiences of maternal and newborn care, and their ideas for improvement in one province, East New Britain, in PNG. METHODS: We undertook a qualitative descriptive study in partnership with and alongside five local health facilities, health care workers and community members, using a Partnership Defined Quality Approach. We conducted ten focus group discussions with 68 community members (identified through church, market and other community-based groups) in East New Britain PNG to explore perspectives and experiences of maternal and newborn care, identify enablers and barriers to quality care and interventions to improve care. Discussions were transcribed verbatim. A mixed inductive and deductive analysis was conducted including application of the World Health Organisation (WHO) Quality Maternal and Newborn Care framework. RESULTS: Using the WHO framework, we present the findings in accordance with the five experience of care domains. We found that the community reported multiple challenges in accessing care and facilities were described as under-staffed and under resourced. Community members emphasised the importance of good communication and competent, caring and respectful healthcare workers. Both women and men expressed a strong desire for companionship during labor and birth. Several changes were suggested by the community that could immediately improve the quality of care. CONCLUSIONS: Community perspectives and experiences are critical for informing effective and sustainable interventions to improve the quality of maternal and newborn care and increasing facility-based births in PNG. A greater understanding of the care experience as a key component of quality care is needed and any quality improvement initiatives must include the user experience as a key outcome measure.

Improving the care provided to, and experienced by, women and their families during pregnancy and childbirth is important for improving the health of mothers and babies. Community members should be involved in thinking about appropriate ways to improve care. Papua New Guinea (PNG) is a country in the Pacific which faces multiple challenges to improving care during pregnancy and birth. We aimed to understand what community members think about care provided and experienced during labour and birth in East New Britain, a rural province of PNG. We worked with five health facilities, health workers and community members in East New Britain to develop a qualitative research project. We carried out 10 focus group discussions with community members in East New Britain to understand what the provision and experience of care was like during labour and birth, and ways that it could be improved. We found that community members identified multiple challenges in getting to facilities and many facilities were found to have not enough supplies, equipment, or staff. Community members wanted staff that were good at their work but also caring and respectful. Women wanted to have support people present during labour and birth and many men wanted to be present too. Our results show that it is important to understand what the community thinks about the quality of care during labour and birth and this information is helpful to design effective activities to improve the care provided and experienced.

The use of newborn foot length to identify low birth weight and preterm babies in Papua New Guinea: A diagnostic accuracy study.

Low birth weight (LBW, <2.50 kg) and preterm birth (PTB, <37 completed weeks of gestation) are important contributors to neonatal death. Newborn foot length has been reported to identify LBW and PTB babies. The objectives of this study were to determine the diagnostic accuracy of foot length to identify LBW and PTB and to compare foot length measurements of a researcher with those of trained volunteers in Papua New Guinea. Newborn babies were enrolled prospectively with written informed consent from their mothers, who were participating in a clinical trial in Madang Province. The reference standards were birth weight, measured by electronic scales and gestational age at birth, based on ultrasound scan and last menstrual period at the first antenatal visit. Newborn foot length was measured within 72 hours of birth with a firm plastic ruler. Optimal foot length cut-off values for LBW and PTB were derived from receiver operating characteristic curve analysis. Bland-Altman analysis was used to assess inter-observer agreement. From 12 October 2019 to 6 January 2021, we enrolled 342 newborns (80% of those eligible); 21.1% (72/342) were LBW and 7.3% (25/342) were PTB. The area under the curve for LBW was 87.0% (95% confidence intervals 82.8-90.2) and for PTB 85.6% (81.5-89.2). The optimal foot length cut-off was <7.7 cm for both LBW (sensitivity 84.7%, 74.7-91.2, specificity 69.6%, 63.9-74.8) and PTB (sensitivity 88.0% (70.0-95.8), specificity 61.8% (56.4-67.0). In 123 babies with paired measurements, the mean difference between the researcher and volunteer measurements was 0.07 cm (95% limits of agreement -0.55 to +0.70) and 7.3% (9/123) of the pairs were outside the 95% limits of agreement. When birth at a health facility is not possible, foot length measurement can identify LBW and PTB in newborns but needs appropriate training for community volunteers and evaluation of its impact on healthcare outcomes.

Improving maternal and newborn health and reducing stillbirths in the Western Pacific Region - current situation and the way forward.

Despite positive trends in many indicators, there remains an unacceptable burden of preventable maternal, newborn deaths and stillbirths every year. This paper provides an overview of the maternal and perinatal outcomes across 22 Pacific Island Countries and Territories, including Papua New Guinea. We highlight some unique challenges and provide examples of initiatives in three of the larger countries to contribute to safer childbirth. There are high maternal and perinatal morbidity and mortality rates in many of the countries, although reliable data are limited. There are currently no data relating to the burden of intrapartum-related maternal and perinatal morbidity or stillbirth or the quality of intrapartum care. Varying definitions across countries for perinatal indicators mean that meaningful comparisons are difficult and unreliable. There is need for midwives and other maternal and newborn health providers to improve maternal and newborn indicators as countries advance towards the 2030 Sustainable Development Goals.

Low knowledge of newborn danger signs among pregnant women in Papua New Guinea and implications for health seeking behaviour in early infancy - findings from a longitudinal study.

BACKGROUND: Globally, 2.5 million babies die in the first 28 days of life each year with most of these deaths occurring in low- and middle-income countries. Early recognition of newborn danger signs is important in prompting timely care seeking behaviour. Little is known about women's knowledge of newborn danger signs in Papua New Guinea. This study aims to assess this knowledge gap among a cohort of women in East New Britain Province. METHODS: This study assessed knowledge of newborn danger signs (as defined by the World Health Organization) at three time points from a prospective cohort study of women in East New Britain Province, factors associated with knowledge of danger signs after childbirth were assessed using logistic regression. This study includes quantitative and qualitative interview data from 699 pregnant women enrolled at their first antenatal clinic visit, followed up after childbirth (n = 638) and again at one-month post-partum (n = 599). RESULTS: Knowledge of newborn danger signs was very low. Among the 638 women, only 9.4% knew three newborn danger signs after childbirth and only one knew all four essential danger signs defined by Johns Hopkins University 'Birth Preparedness and Complication Readiness' Index. Higher knowledge scores were associated with higher gravidity, income level, partner involvement in antenatal care, and education. CONCLUSION: Low levels of knowledge of newborn danger signs among pregnant women are a potential obstacle to timely care-seeking in rural Papua New Guinea. Antenatal and postnatal education, and policies that support enhanced education and decision-making powers for women and their families, are urgently needed.

Sexual and reproductive health needs and practices of female sex workers in Papua New Guinea: findings from a biobehavioral survey Kauntim mi tu ('Count me too').

BACKGROUND: Little research has explored the sexual and reproductive health (SRH) experience of female sex workers (FSW), including girls aged < 18 years who are commercially sexually exploited (CSE), in Papua New Guinea (PNG). This paper describes the SRH history of FSW and CSE girls and factors associated with their use of moderately or highly effective contraceptive methods in three settings in PNG. METHODS: From 2016 to 2017, respondent-driven sampling (RDS) surveys were conducted among FSW and CSE girls in Port Moresby, Lae, and Mt. Hagen. FSW and CSE girls who were born female, aged ≥12 years, sold or exchanged vaginal sex in the past 6 months, spoke English or Tok Pisin, and had a valid RDS study coupon were eligible to participate. Interviews were conducted face-to-face and participants were offered rapid routine HIV and syphilis testing. Survey logistic regression procedures were used to identify factors associated with the use of moderately or highly effective contraceptive methods. Weighted data analysis was conducted. RESULTS: A total of 2901 FSW and CSE girls (Port Moresby, 673; Lae, 709; and Mt. Hagen, 709) were enrolled. The proportion using moderately or highly effective contraceptive methods was 37.7% in Port Moresby, 30.9% in Lae, and 26.5% in Mt. Hagen. After adjusting for covariates, factors significantly associated with the use of moderately or highly effective contraceptive methods in Port Moresby were being age 20-24, being married, being divorced or separated, having one or more dependent children, being away from home for more than 1 month in the last 6 months, and having tested HIV negative. No factors were significantly associated in Lae or Mt. Hagen. ANC attendance amongst FSW and CSE girls who gave birth in last 3 years was highest in Port Moresby at 91.2%. HIV testing was inconsistently and inadequately offered at ANC across the three cities. CONCLUSIONS: Kauntim mi tu provides much-needed insight into the SRH experiences of FSW and CSE girls in PNG, where their use of moderately or highly effective contraceptive methods is low. We hope to shed light on the complicated reality they face due to illegality of sex work and multitude of complex healthcare experiences.

Quality newborn care in East New Britain, Papua New Guinea: measuring early newborn care practices and identifying opportunities for improvement.

BACKGROUND: Renewed attention and investment is needed to improve the quality of care during the early newborn period to address preventable newborn deaths and stillbirths in Papua New Guinea (PNG). We aimed to assess early newborn care practices and identify opportunities for improvement in one province (East New Britain) in PNG. METHODS: A mixed-methods study was undertaken in five rural health facilities in the province using a combination of facility audits, labour observations and qualitative interviews with women and maternity providers. Data collection took place between September 2019 and February 2020. Quantitative data were analysed descriptively, whilst qualitative data were analysed using content analysis. Data were triangulated by data source. RESULTS: Five facility audits, 30 labour observations (in four of the facilities), and interviews with 13 women and eight health providers were conducted to examine early newborn care practices. We found a perinatal mortality rate of 32.2 perinatal deaths per 1000 total births and several barriers to quality newborn care, including an insufficient workforce, critical infrastructure and utility constraints, and limited availability of essential newborn medicines and equipment. Most newborns received at least one essential newborn care practice in the first hour of life, such as immediate and thorough drying (97%). CONCLUSIONS: We observed high rates of essential newborn care practices including immediate skin-to-skin and delayed cord clamping. We also identified multiple barriers to improving the quality of newborn care in East New Britain, PNG. These findings can inform the development of effective interventions to improve the quality of newborn care. Further, this study demonstrates that multi-faceted programs that include increased investment in the health workforce, education and training, and availability of essential equipment, medicines, and supplies are required to improve newborn outcomes.

Adverse pregnancy and perinatal outcomes associated with Mycoplasma genitalium: systematic review and meta-analysis.

OBJECTIVE: To examine associations between Mycoplasma genitalium infection during pregnancy and adverse outcomes. METHODS: We did a systematic review of observational studies. We searched Medline, EMBASE, the Cochrane Library and CINAHL up to 11 August 2021. Studies were included if they compared preterm birth, spontaneous abortion, premature rupture of membranes, low birth weight or perinatal death between women with and without M. genitalium. Two reviewers independently assessed articles for inclusion and extracted data. We used random-effects meta-analysis to estimate summary ORs and adjusted ORs, with 95% CIs, where appropriate. Risk of bias was assessed using established checklists. RESULTS: We identified 116 records and included 10 studies. Women with M. genitalium were more likely to experience preterm birth in univariable analyses (summary unadjusted OR 1.91, 95% CI 1.29 to 2.81, I2=0%, 7 studies). The combined adjusted OR was 2.34 (95% CI 1.17 to 4.71, I2=0%, 2 studies). For spontaneous abortion, the summary unadjusted OR was 1.00 (95% CI 0.53 to 1.89, I2=0%, 6 studies). The adjusted OR in one case-control study was 0.9 (95% CI 0.2 to 3.8). Unadjusted ORs for premature rupture of membranes were 7.62 (95% CI 0.40 to 145.86, 1 study) and for low birth weight 1.07 (95% CI 0.02 to 10.39, 1 study). For perinatal death, the unadjusted OR was 1.07 (95% CI 0.49 to 2.36) in one case-control and 38.42 (95% CI 1.45 to 1021.43) in one cohort study. These two ORs were not combined, owing to heterogeneity. The greatest risk of bias was the failure in most studies to control for confounding. CONCLUSION: M. genitalium might be associated with an increased risk of preterm birth. Further prospective studies, with adequate control for confounding, are needed to understand the role of M. genitalium in adverse pregnancy outcomes. There is insufficient evidence to indicate routine testing and treatment of asymptomatic M. genitalium in pregnancy. PROSPERO REGISTRATION NUMBER: CRD42016050962.

Partnership-defined quality approach to companionship during labour and birth in East New Britain, Papua New Guinea: A mixed-methods study.

Companionship during labour and birth is a critical component of quality maternal and newborn care, resulting in improved care experiences and better birth outcomes. Little is known about the preferences and experiences of companionship in Papua New Guinea (PNG), and how it can be implemented in a culturally appropriate way. The aim of this study was to describe perspectives and experiences of women, their partners and health providers regarding labour and birth companionship, identify enablers and barriers and develop a framework for implementing this intervention in PNG health facilities. A mixed methods study was conducted with five facilities in East New Britain, PNG. Data included 5 facility audits, 30 labour observations and 29 in-depth interviews with women who had recently given birth, partners and maternity care providers. A conceptual framework was developed drawing on existing quality care implementation frameworks. Women and partners wanted companions to be present, whilst health providers had mixed views. Participants described benefits of companionship including encouragement and physical support for women, better communication and advocacy, improved labour outcomes and assistance with workforce issues. Adequate privacy and space constraints were highlighted as key barriers to address. Of the women observed, only 30% of women had a companion present during labour, and 10% had a companion at birth. A conceptual framework was used to highlight the interconnected inputs required at community, facility and provincial health system levels to improve the quality of care. Key elements to address included attitudes towards companionship, the need for education and training and restrictive hospital policies. Supporting women to have their companion of choice present during labour and birth is critical to improving women's experiences of care and improving the quality of maternal and newborn care. In order to provide companionship during labour and birth in PNG, a complex, intersecting, multi-faceted approach is required.

Point-of-care testing and treatment of sexually transmitted and genital infections during pregnancy in Papua New Guinea (WANTAIM trial): protocol for an economic evaluation alongside a cluster-randomised trial.

INTRODUCTION: Left untreated, sexually transmitted and genital infections (henceforth STIs) in pregnancy can lead to serious adverse outcomes for mother and child. Papua New Guinea (PNG) has among the highest prevalence of curable STIs including syphilis, chlamydia, gonorrhoea, trichomoniasis and bacterial vaginosis, and high neonatal mortality rates. Diagnosis and treatment of these STIs in PNG rely on syndromic management. Advances in STI diagnostics through point-of-care (PoC) testing using GeneXpert technology hold promise for resource-constrained countries such as PNG. This paper describes the planned economic evaluation of a cluster-randomised cross-over trial comparing antenatal PoC testing and immediate treatment of curable STIs with standard antenatal care in two provinces in PNG. METHODS AND ANALYSIS: Cost-effectiveness of the PoC intervention compared with standard antenatal care will be assessed prospectively over the trial period (2017-2021) from societal and provider perspectives. Incremental cost-effectiveness ratios will be calculated for the primary health outcome, a composite measure of the proportion of either preterm birth and/or low birth weight; for life years saved; for disability-adjusted life years averted; and for non-health benefits (financial risk protection and improved health equity). Scenario analyses will be conducted to identify scale-up options, and budget impact analysis will be undertaken to understand short-term financial impacts of intervention adoption on the national budget. Deterministic and probabilistic sensitivity analysis will be conducted to account for uncertainty in key model inputs. ETHICS AND DISSEMINATION: This study has ethical approval from the Institutional Review Board of the PNG Institute of Medical Research; the Medical Research Advisory Committee of the PNG National Department of Health; the Human Research Ethics Committee of the University of New South Wales; and the Research Ethics Committee of the London School of Hygiene and Tropical Medicine. Findings will be disseminated through national stakeholder meetings, conferences, peer-reviewed publications and policy briefs. TRIAL REGISTRATION NUMBER: ISRCTN37134032.

Mycoplasma genitalium and Other Reproductive Tract Infections in Pregnant Women, Papua New Guinea, 2015-2017.

Much about the range of pathogens, frequency of coinfection, and clinical effects of reproductive tract infections (RTIs) among pregnant women remains unknown. We report on RTIs (Mycoplasma genitalium, Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Treponema pallidum subspecies pallidum, bacterial vaginosis, and vulvovaginal candidiasis) and other reproductive health indicators in 699 pregnant women in Papua New Guinea during 2015-2017. We found M. genitalium, an emerging pathogen in Papua New Guinea, in 12.5% of participants. These infections showed no evidence of macrolide resistance. In total, 74.1% of pregnant women had >1 RTI; most of these infections were treatable. We detected sexually transmitted infections (excluding syphilis) in 37.7% of women. Our findings showed that syndromic management of infections is greatly inadequate. In total, 98.4% of women had never used barrier contraception. These findings will inform efforts to improve reproductive healthcare in Papua New Guinea.

Early neonatal death review from two provinces in Papua New Guinea: A retrospective analysis.

AIM: To determine the causes of early neonatal death and the avoidable factors associated with these deaths among women participating in a cluster-randomised crossover trial in Papua New Guinea. METHODS: Early neonatal deaths were identified by retrospective chart review of the Women and Newborn Trial of Antenatal Interventions and Management study participants between July 2017 and January 2020. Causes of death and avoidable factors were identified using the Perinatal Problem Identification Program system. RESULTS: There were 35 early neonatal deaths among 2499 livebirths (14 per 1000 births). Fifty-seven percent (20/35) of deaths occurred on the first day of life. Idiopathic preterm birth was the leading obstetric cause of perinatal death (29%; 10/35). Extreme multi-organ immaturity (23%; 8/35) and hypoxic ischaemic encephalopathy (17%; 6/35) were the most common final causes of neonatal death. Forty-six avoidable factors were identified among 26 deaths, including delays in care-seeking, insufficient resources at health facilities, poor intrapartum care and immediate care of the newborn, including neonatal resuscitation. CONCLUSION: In this study, potentially preventable causes and avoidable factors were identified in the majority of early neonatal deaths. Addressing these factors will require health system strengthening, particularly the upskilling of primary level health staff, as well as targeted health education of women and the community.

Risk factors and knowledge associated with high unintended pregnancy rates and low family planning use among pregnant women in Papua New Guinea.

Unintended pregnancy is a major driver of poor maternal and child health in resource-limited settings. Data on pregnancy intention and use of family planning (FP) is scarce in Papua New Guinea (PNG), but are needed to inform public health strategies to improve FP accessibility and uptake. Data from a facility-based cross-sectional sample of 699 pregnant women assessed prevalence and predictors of unintended pregnancy and modern FP use among pregnant women in East New Britain Province, PNG. More than half (55%) the women reported their pregnancy as unintended. Few (18%) reported ever having used a modern FP method, and knowledge of different methods was low. Being single, separated or divorced (AOR 9.66; 95% CI 3.27-28.54), educated to a tertiary or vocational level (AOR 1.78 CI 1.15-2.73), and gravidity > 1 (AOR 1.43 for each additional pregnancy CI 1.29-1.59) were associated with unintended pregnancy; being accompanied by a male partner to ANC was associated with a reduced unintended pregnancy (0.46 CI 0.30-0.73). Factors associated with modern FP use included male partner involvement (AOR 2.26 CI 1.39-3.67) and gravidity > 1 (AOR 1.54 for each additional pregnancy CI 1.36-1.74). FP use also varied by the facility women attended. Findings highlight an urgent need for targeted interventions to improve FP knowledge, uptake and access, and male partner involvement, to reduce unintended pregnancies and their complications.

Adverse pregnancy and neonatal outcomes associated with Neisseria gonorrhoeae: systematic review and meta-analysis.

OBJECTIVE: To examine associations between Neisseria gonorrhoeae (NG) infection during pregnancy and the risk of preterm birth, spontaneous abortion, premature rupture of membranes, perinatal mortality, low birth weight and ophthalmia neonatorum. DATA SOURCES: We searched Medline, EMBASE, the Cochrane Library and Cumulative Index to Nursing and Allied Health Literature for studies published between 1948 and 14 January 2020. METHODS: Studies were included if they reported testing for NG during pregnancy and compared pregnancy, perinatal and/or neonatal outcomes between women with and without NG. Two reviewers independently assessed papers for inclusion and extracted data. Risk of bias was assessed using established checklists for each study design. Summary ORs with 95% CIs were generated using random effects models for both crude and, where available, adjusted associations. RESULTS: We identified 2593 records and included 30 in meta-analyses. Women with NG were more likely to experience preterm birth (OR 1.55, 95% CI 1.21 to 1.99, n=18 studies); premature rupture of membranes (OR 1.41, 95% CI 1.02 to 1.92, n=9); perinatal mortality (OR 2.16, 95% CI 1.35 to 3.46, n=9); low birth weight (OR 1.66, 95% CI 1.12 to 2.48, n=8) and ophthalmia neonatorum (OR 4.21, 95% CI 1.36 to 13.04, n=6). Summary adjusted ORs were, for preterm birth 1.90 (95% CI 1.14 to 3.19, n=5) and for low birth weight 1.48 (95% CI 0.79 to 2.77, n=4). In studies with a multivariable analysis, age was the variable most commonly adjusted for. NG was more strongly associated with preterm birth in low-income and middle-income countries (OR 2.21, 95% CI 1.40 to 3.48, n=7) than in high-income countries (OR 1.38, 95% CI 1.04 to 1.83, n=11). CONCLUSIONS: NG is associated with a number of adverse pregnancy and newborn outcomes. Further research should be done to determine the role of NG in different perinatal mortality outcomes because interventions that reduce mortality will have the greatest impact on reducing the burden of disease in low-income and middle-income countries. PROSPERO REGISTRATION NUMBER: CRD42016050962.

Perinatal death audit and classification of stillbirths in two provinces in Papua New Guinea: A retrospective analysis.

OBJECTIVE: To undertake a retrospective perinatal death audit and assessment of avoidable factors associated with stillbirths among a cohort of women in two provinces in Papua New Guinea. METHODS: We used data from an ongoing cluster-randomized crossover trial in 10 sites among 4600 women in Papua New Guinea (from 2017 to date). The overarching aim is to improve birth outcomes. All stillbirths from July 2017 to January 2020 were identified. The Perinatal Problem Identification Program was used to analyze each stillbirth and review associated avoidable factors. RESULTS: There were 59 stillbirths among 2558 births (23 per 1000 births); 68% (40/59) were classified "fresh" and 32% as "macerated". Perinatal cause of death was identified for 63% (37/59): 30% (11/37) were due to intrapartum asphyxia and traumatic breech birth and 19% (7/37) were the result of pre-eclampsia. At least one avoidable factor was identified for 95% (56/59) of stillbirths. Patient-associated factors included lack of response to reduced fetal movements and delay in seeking care during labor. Health personnel-associated factors included poor intrapartum care, late diagnosis of breech presentation, and prolonged second stage with no intervention. CONCLUSION: Factors associated with stillbirths in this setting could be avoided through a package of interventions at both the community and health-facility levels.

Strengthening routine immunization in Papua New Guinea: a cross-sectional provincial assessment of front-line services.

BACKGROUND: Routine immunization programs face many challenges in settings such as Papua New Guinea with dispersed rural populations, rugged geography and limited resources for transport and health. Low routine coverage contributes to disease outbreaks such as measles and the polio that re-appeared in 2018. We report on an in-depth local assessment that aimed to document immunization service provision so as to review a new national strategy, and consider how routine immunization could be better strengthened. METHODS: In East New Britain Province, over 2016 and 17, we carried out a cross-sectional assessment of 12 rural health facilities, staff and clients. The study was timed to follow implementation of a new national strategy for strengthening routine immunization. We used interview, structured observation, and records review, informed by theory-based evaluation, a World Health Organization quality checklist, and other health services research tools. RESULTS: We documented strengths and weaknesses across six categories of program performance relevant to national immunization strategy and global standards. We found an immunization service with an operational level of staff, equipment and procedures in place; but one that could reach only half to two thirds of its target population. Stronger routine services require improvement in: understanding of population catchments, tracking the unvaccinated, reach and efficiency of outreach visits, staff knowledge of vaccination at birth and beyond the first year of life, handling of multi-dose vials, and engagement of community members. Many local suggestions to enhance national plans, included more reliable on-demand services, integration of other family health services and increased involvement of men. CONCLUSIONS: The national strategy addresses most local gaps, but implementation and resourcing requires greater commitment. Long-term strengthening requires a major increase in centrally-allocated resources, however there are immediate locally feasible steps within current resources that could boost coverage and quality of routine immunization especially through better population-based local planning, and stronger community engagement. Our results also suggest areas where vaccination campaigns in PNG can contribute to routine immunization services.

HPV vaccination in Papua New Guinea to prevent cervical cancer in women: Gender, sexual morality, outsiders and the de-feminization of the HPV vaccine.

Papua New Guinea has among the highest estimated burden of cervical cancer globally, but currently lacks national cervical screening or human papillomavirus (HPV) vaccination programmes. The Papua New Guinean government is committed to introducing the HPV vaccine for primary prevention, but locally-relevant research evidence is not available to guide implementation. Experience from earlier Papua New Guinean health programmes suggests that appropriate engagement with local health cosmologies and cultures for health/wellbeing, illness/disease, and recognition of the role of 'outsiders' in preventing, promoting or contributing to sickness, are essential to the successful introduction of biomedical interventions in this setting. We describe findings from a multi-site qualitative study undertaken in three provinces in Papua New Guinea (2012-14). Twenty-one gender specific focus group discussions and 82 semi-structured interviews, with a total of 208 participants, were conducted. There was strong community support for the introduction of the HPV vaccine for cervical cancer prevention in Papua New Guinea. Significantly, and despite being officially discussed in the context of a planned future intervention focusing on vaccinating young girls to prevent cervical cancer, the intervention was de-feminised, where both girls and boys were supported to be vaccinated in any HPV programme in Papua New Guinea.

Point-of-care testing and treatment of sexually transmitted infections to improve birth outcomes in high-burden, low-income settings: Study protocol for a cluster randomized crossover trial (the WANTAIM Trial, Papua New Guinea).

Background: Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and bacterial vaginosis have been associated with preterm birth and low birth weight, and are highly prevalent among pregnant women in many low- and middle-income settings. There is conflicting evidence on the potential benefits of screening and treating these infections in pregnancy. Newly available diagnostic technologies make it possible, for the first time, to conduct definitive field trials to fill this knowledge gap. The primary aim of this study is to evaluate whether antenatal point-of-care testing and immediate treatment of these curable sexually transmitted and genital infections (STIs) leads to reduction in preterm birth and low birth weight. Methods: The Women and Newborn Trial of Antenatal Interventions and Management (WANTAIM) is a cluster-randomised crossover trial in Papua New Guinea to compare point-of-care STI testing and immediate treatment with standard antenatal care (which includes the WHO-endorsed STI 'syndromic' management strategy based on clinical features alone without laboratory confirmation). The unit of randomisation is a primary health care facility and its catchment communities. The primary outcome is a composite measure of two events: the proportion of women and their newborns in each trial arm, who experience either preterm birth (delivery <37 completed weeks of gestation as determined by ultrasound) and/or low birth weight (<2500 g measured within 72 hours of birth). The trial will also evaluate neonatal outcomes, as well as the cost-effectiveness, acceptability and health system requirements of this strategy, compared with standard care. Conclusions: WANTAIM is the first randomised trial to evaluate the effectiveness, cost-effectiveness, acceptability and health system requirements of point-of-care STI testing and treatment to improve birth outcomes in high-burden settings. If the intervention is proven to have an impact, the trial will hasten access to these technologies and could improve maternal and neonatal health in high-burden settings worldwide. Registration: ISRCTN37134032.

Adverse pregnancy and neonatal outcomes associated with Neisseria gonorrhoeae, Mycoplasma genitalium, M. hominis, Ureaplasma urealyticum and U. parvum: a systematic review and meta-analysis protocol.

INTRODUCTION: Several bacterial sexually transmitted and genital mycoplasma infections during pregnancy have been associated with poor pregnancy and perinatal outcomes. Comprehensive and systematic information about associations between sexually transmitted infections (STI) and genital infections in pregnancy and adverse perinatal outcomes is needed to improve understanding about the evidence for causal associations between these infections and adverse pregnancy and neonatal outcomes. Our primary objective is to systematically review the literature about associations between: (1) Neisseria gonorrhoeae in pregnancy and preterm birth; (2) Mycoplasma genitalium in pregnancy and preterm birth; (3) M. hominis, Ureaplasma urealyticum and/or U. parvum in pregnancy and preterm birth. METHODS AND ANALYSIS: We will undertake a systematic search of Medline, Excerpta Medica database and the Cochrane Library and Cumulative Index to Nursing and Allied Health Literature. Following an initial screening of titles by one reviewer, abstracts will be independently assessed by two reviewers before screening of full-text articles. To exclude a manuscript, both reviewers need to agree on the decision. Any discrepancies will be resolved by discussion, or the adjudication of a third reviewer. Studies will be included if they report testing for one or more of N. gonorrhoeae, M. genitalium, M. hominis, U. urealyticum and/or U. parvum during pregnancy and report pregnancy and/or birth outcomes. In this review, the primary outcome is preterm birth. Secondary outcomes are premature rupture of membranes, low birth weight, spontaneous abortion, stillbirth, neonatal mortality and ophthalmia neonatorum. We will use standard definitions, or definitions reported by study authors. We will examine associations between exposure and outcome in forest plots, using the I2 statistic to examine between study heterogeneity. Where appropriate, we will use meta-analysis to combine results of individual studies. ETHICS AND DISSEMINATION: This systematic review of published literature does not require ethical committee approval. Results of this review will be published in a peer reviewed, open access journal. PROSPERO REGISTRATION NUMBER: CRD42016050962.