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.

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.

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.

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.