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.

Incidence of self-induced abortion with misoprostol, admitted to a provincial hospital in Papua New Guinea: A prospective observational study.

BACKGROUND: Misoprostol is a life-savingmedication in obstetric practice but the prevalence of misoprostol-related self-induced abortion is increasing in many communities. AIMS: To investigate the hospital incidence, clinical management, and legal framework of self-induced abortions with misoprostol. MATERIALS AND METHODS: This was a prospective observational study conducted over 18 months. All patients <20 weeks pregnant who were admitted with a diagnosis of misoprostol-induced abortion were included in the study. RESULTS: Of 186 women with abortion-related admissions during the study period, 51 (27.4%) women reported using misoprostol to induce abortion. The majority were young (27.8 ± 5.5) married women (32/51: 62.7%), particularly educated (27/51: 52.9%) employed women (27/51: 52.9%), who were not on any contraception (46/51: 90.1%). Most abortions were induced in the first trimester (39/51: 76.5%) and patients were admitted because of prolonged bleeding (23/51: 45.1%). A significant proportion of participants who did not receive the correct dose of misoprostol developed sepsis compared to those who received a correct dose (6/18 (33.3%) vs 1/30 (3.3%); P = 0.008). CONCLUSION: The use of misoprostol as an abortifacient is increasing in Papua New Guinea, particularly among educated and employed women. A review of the laws to meet the demand for abortion services and to limit complications of unsafe abortion practices is required.

Safety and efficacy of an oral misoprostol standard-dose regimen vs a low-dose regimen for induction of labour in Papua New Guinean women: An open-label randomised controlled trial.

BACKGROUND: Oral misoprostol is widely used for induction of labour (IOL) in developing countries because of its many advantages. However, limited data exist concerning its safety and efficacy when lower doses are used. AIM: To determine the safety and efficacy of a low-dose oral misoprostol regimen (commencing at 12 µg) compared to a standard-dose regimen (commencing at 25 µg) in Papua New Guinea (PNG) women undergoing IOL. MATERIALS AND METHODS: This was an open-label non-inferiority randomised controlled trial conducted at a provincial hospital in PNG. Women with singleton pregnancies ≥36 weeks with cephalic presentation and a Bishops score of <6, requiring IOL were enrolled. Both regimens were incremented second-hourly to a maximum required dose within 24 h or until commencement of labour. The primary outcome was the proportion of women who delivered within 24 h of drug administration without any severe adverse events. RESULTS: Of the 262 women induced (130 standard-dose vs 132 low-dose), rates of successful induction were high for both regimens (120/130 (92%) vs 118/132 (89%); P = 0.52). Fourteen women (11%) in the standard-dose regimen and 20 (15%) in the low-dose regimen had severe adverse events. There was no significant difference in the safety profile of the two regimens (106/130 (82%) vs 98/132 (74%); P = 0.18). The induction-to-delivery time was significantly shorter in the standard-dose arm (15.2 ± 8.7 h vs 18.0 ± 9.1 h; P = 0.01). CONCLUSION: The standard-dose regimen for IOL has greater efficacy in reducing induction-to-delivery time compared to the low-dose regimen. There was no significant difference in the number of adverse events between the two regimens.

Mortality and morbidity after emergency peripartum hysterectomy in a provincial referral hospital in Papua New Guinea: A seven-year audit.

BACKGROUND: Emergency peripartum hysterectomy (EPH) is a life-saving surgical procedure performed at the time of caesarean section or within 24 h of vaginal delivery and is usually a procedure of last resort in obstetric haemorrhage when other interventions fail. AIM: To investigate the incidence, indications, risk factors and complications of EPH in a provincial referral hospital in Papua New Guinea (PNG). MATERIALS AND METHODS: This was a seven-year retrospective observational study investigating the rate of EPH at a provincial hospital between January 2012 and December 2018. Patient medical records that included socio-demographics, obstetric risk factors, indications for EPH and maternal and perinatal outcomes were reviewed. RESULTS: Of the 19 215 deliveries during the study period, 26 women had EPH, giving an incidence of 1.35 per 1000 deliveries. The majority of women (18/26) were referred from peripheral health facilities. Overall, 21 women survived and five died (mortality index, 19%). Uterine rupture was the most common indication for EPH (13/26), and it was associated with a high maternal death rate of 15.4% (2/13) and significantly higher perinatal deaths when compared to babies born to mothers with other indications (13/13 (100%) versus 5/13 (38.5%); P = 0.002). Neonates born to mothers with uterine atony were more likely to survive (8/11 (72.7%) versus 0/15 (0%); P < 0.001), although maternal mortality was higher at 27.3% (3/11). CONCLUSION: Uterine rupture and uterine atony after prolonged labour are common indications of EPH and associated with significant maternal and perinatal mortality. Improving pre-hospital management of prolonged labour remains critical in PNG.

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.

The burden of presumed tuberculosis in hospitalized children in a resource-limited setting in Papua New Guinea: a prospective observational study.

Background: In Papua New Guinea, TB is considered to be a major public health problem, but little is known about the prevalence and prognosis of presumed TB in children. Methods: As part of a prospective hospital-based surveillance on the northern coast of mainland Papua New Guinea, the authors investigated the admission prevalence and case fatality rate associated with presumed TB over a 6-year period (2011-2016). All children admitted who were diagnosed with TB were followed-up until discharge or death. Results: Of 8992 paediatric admissions, 734 patients (8.2%) were diagnosed with presumed TB and there were 825 deaths, with TB accounting for 102 (12.4%). Extrapulmonary TB was the final diagnosis in 384 admissions {prevalence 4.3% [384/8992 (95% CI 3.9-4.7)]} with a case fatality rate of 21.4% [82/384 (95% CI 17.4-25.9)]. TB meningitis, disseminated TB and pericardial TB had high case fatality rates of 29.0% (53/183), 28.9% (11/38) and 25% (4/16), respectively. Severe malnutrition was more common in patients with pulmonary compared with extrapulmonary TB (25.4% vs 15.6%; p<0.01). Conclusions: Improved community-based case detection strategies, routine BCG vaccinations and other effective forms of TB control need revitalization and sustainability to reduce the high case fatality rates associated with childhood TB in Papua New Guinea.

Safety and effectiveness of oral misoprostol for induction of labour in a resource-limited setting: a dose escalation study.

BACKGROUND: Oral misoprostol as an induction of labour (IOL) agent is rapidly gaining popularity in resource-limited settings because it is cheap, stable at ambient temperatures, and logistically easier to administer compared to dinoprostone and oxytocin. We aim to investigate the safety and effectiveness of a regimen of oral misoprostol in Papua New Guinean women undergoing IOL. METHODS: As part of a prospective dose escalation study conducted at Modilon Hospital in Papua New Guinea, women with a singleton pregnancy in cephalic presentation and an unfavourable cervix who gave written informed consent were administered oral misoprostol, commencing at 25mcg once every 2 h for 4 doses and increased to 50mcg once every 2 h for 8 doses within 24 h. The primary outcomes studied were i) the proportion of women delivering within 24 h of oral misoprostol administration, and ii) rates of maternal and perinatal severe adverse events. RESULTS: Of 6167 labour ward screened admissions, 209 women (3%) fulfilled the study inclusion criteria and underwent IOL. Overall, 74% (155/209 [95% confidence interval 67.6-79.9]) delivered within 24 h. Most women (90%; 188/209; 95% CI [84.9-93.5]) delivered vaginally with 86% (180/209) having a good outcome for both the mother and baby. Of the 10% (21/209) who failed IOL and underwent caesarean section, a significant proportion of their babies were admitted to special-care nursery compared to babies delivered vaginally (20/21 [95%] versus 8/188 [4%]; Fisher Exact test P < 0.001), but their perinatal mortality rate was not significantly higher (1/21 [5%] versus 2/188 [1%]; P = 0.30). The only maternal death was not study related and occurred in a patient with post-partum haemorrhage, 15 h post-delivery. CONCLUSION: The oral misoprostol regimen for IOL described in the present study is safe, effective and logistically feasible to administer in a resource-limited setting.

Maternal near-misses at a provincial hospital in Papua New Guinea: A prospective observational study.

BACKGROUND: Maternal near-miss indices are World Health Organisation (WHO) recognised indicators that may improve our understanding of factors associated with maternal morbidity and mortality. In Papua New Guinea (PNG) where maternal mortality is among the highest in the world, only one study has documented near-miss indices in a tertiary-level hospital, but none from provincial hospitals where the majority of under-privileged women access healthcare services. AIMS: To determine the near-miss ratio, maternal mortality index (MMI), and associated maternal indices for Modilon Hospital in Madang Province of PNG. METHODS: All women attending Modilon Hospital who met the WHO maternal near-miss definition and/or a WHO-modified (PNG-specific) near-miss definition, were prospectively enrolled. RESULTS: There were 6019 live births during the audit period; 163 women presented with life-threatening conditions (153 near-misses and 10 maternal deaths). The maternal near-miss ratio was 25.4/1000 live births and the maternal mortality ratio (MMR) was 166/100 000 live births, with a maternal death to near-miss ratio of 1:15.3. The severe maternal outcome ratio was 27.1/1000 live births and the total mortality index was 6.8%. Higher proportions of near-miss women were aged ≥30 years, nulliparous, illiterate, from rural communities, lacked formal employment, referred from peripheral health facilities, unbooked, had history of still births and were anaemic. CONCLUSION: Sociodemographic factors such as women's rights, education level and status in society, in addition to appropriate health reforms with greater financial and political support are urgently needed to ensure underprivileged women in rural PNG have access to family planning, supervised deliveries and skilled emergency obstetric care.

The Burden of Child Maltreatment Leading to Hospitalization in a Provincial Setting in Papua New Guinea.

INTRODUCTION: Child maltreatment is prevalent globally. In Papua New Guinea (PNG), child maltreatment remains an under-reported problem. METHODS: As part of a 10 month prospective observational study conducted at Modilon Hospital in PNG, we investigated the burden of child maltreatment in the form of sexual abuse, physical abuse and neglect, leading to hospitalization in children ≤14 years. RESULTS: Of 1061 screened admissions, 107 (10%) fulfilled the definition of child maltreatment. The in-hospital admission prevalence of sexual abuse was 5.7% [60 of 1061; 95% confidence interval (CI): 4.4-7.3]. Neglect accounted for 3.4% (36 of 1061; 95% CI: 2.4-4.7) of admissions, while physical abuse accounted for 1.0% (11 of 1061; 95% CI: 0.6-1.9). Mortality was highest in the neglected group, with severe acute malnutrition accounting for 89% of deaths. CONCLUSION: Improved awareness, establishment of appropriate channels for addressing child maltreatment and enforcement of child protection laws in PNG and other epidemiologically similar settings are urgently needed.

Insights into maternal mortality in Madang Province, Papua New Guinea.

OBJECTIVE: To assess the frequency, causes, and reporting of maternal deaths at a provincial referral hospital in coastal Papua New Guinea (PNG), and to describe delays in care. METHODS: In a structured retrospective review of maternal deaths at Modilon General Hospital, Madang, PNG, registers and case notes for the period January 2008 to July 2012 were analyzed to determine causes, characteristics, and management of maternal death cases. Public databases were assessed for underreporting. RESULTS: During the review period, there were 64 maternal deaths (institutional maternal mortality ratio, 588 deaths per 100 000 live births). Fifty-two cases were analyzed in detail: 71.2% (n=37) were direct maternal deaths, and hemorrhage (n=24, 46.2%) and infection (n=16, 30.8%) were the leading causes of mortality overall. Women frequently did not attend prenatal clinics (n=34, 65.4%), resided in rural areas (n=45, 86.5%), and experienced delays in care (n=45, 86.5%). Maternal deaths were underreported in public databases. CONCLUSION: The burden of maternal mortality was found to be high at a provincial hospital in PNG. Most women died of direct causes and experienced delays in care. Strategies to complement current hospital and national policy to reduce maternal mortality and to improve reporting of deaths are needed.

The impact of tubal ectopic pregnancy in Papua New Guinea--a retrospective case review.

BACKGROUND: Ectopic pregnancy (EP) is an important cause of morbidity and mortality amongst women of reproductive age. Tubal EP is well described in industrialised countries, but less is known about its impact in low-resource countries, in particular in the South Pacific Region. METHODS: We undertook a retrospective review of women with tubal EP treated at a provincial referral hospital in coastal Papua New Guinea over a period of 56 months. Demographic and clinical variables were obtained from patients' medical records and analysed. The institutional rate of tubal EP was calculated, and diagnosis and management reviewed. Potential risk factors for tubal EP were identified, and delays contributing to increased morbidity described. RESULTS: A total of 73 women had tubal EP. The institutional rate of tubal EP over the study period was 6.3 per 1,000 deliveries. There were no maternal deaths due to EP. The mean age of women was 31.5+/-5.7 years, 85% were parous, 67% were rural dwellers and 62% had a history of sub-fertility. The most commonly used diagnostic aid was culdocentesis. One third of women had clinical evidence of shock on arrival. All women with tubal EP were managed by open salpingectomy. Tubal rupture was confirmed for 48% of patients and was more common amongst rural dwellers. Forty-three percent of women had macroscopic evidence of pelvic infection. Two-thirds of patients received blood transfusions, and post-operative recovery lasted six days on average. Late presentation, lack of clinical suspicion, and delays with receiving appropriate treatments were observed. CONCLUSIONS: Tubal EP is a common gynaecological emergency in a referral hospital in coastal PNG, and causes significant morbidity, in particular amongst women residing in rural areas. Sexually transmitted infections are likely to represent the most important risk factor for tubal EP in PNG. Interventions to reduce the morbidity due to tubal EP include the prevention, detection and treatment of sexually transmitted infections, identification and reduction of barriers to prompt presentation, increasing health workers' awareness of ectopic pregnancy, providing pregnancy test kits to rural health centres, and strengthening hospital blood transfusion services, including facilities for autotransfusion.