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.

A study comparing the WHO C-Model caesarean section rates and observed caesarean section rates at Port Moresby General Hospital, Papua New Guinea.

BACKGROUND: Worldwide, there is an increase in caesarean deliveries. Ideal caesarean section (CS) rates continue to be a matter for debate. The World Health Organization (WHO) C-Model, is a mathematical modelling tool to assist health facilities estimate expected CS rates based on the quality middle income facilities practice. AIM: To compare WHO C-Model derived CS rates with actual CS rates at Port Moresby General Hospital. MATERIALS AND METHODS: Clinical and obstetric data for women who delivered during a four months period was used to calculate CS probability using the WHO C-Model online calculator. Comparisons of CS rates were made for the entire cohort, as well as for each Robson Classification group to assess whether there was either 'under' or 'overusage' of CS according to the C-Model estimates. RESULTS: The actual CS rate of 5.5% (246/4437) was lower than the mean C-Model rate of 8%. The C-Model rate equates to an almost 45% increase in CS rates or an additional 111 caesarean deliveries be done during the four months study period. CONCLUSION: The WHO C-Model had good predictability among most of the low-risk Robson groups that accounted for just over 80% of the study population. The suggested additional 111 caesarean deliveries needed to be performed among high-risk Robson groups represented 15% of the study population. Local hospital protocols pertaining to management of both low- and high-risk cases are credited for keeping CS rates to a minimum. A lower threshold for CS in Robson groups two and four could have led to better perinatal outcomes.

Point-of-care HPV DNA testing of self-collected specimens and same-day thermal ablation for the early detection and treatment of cervical pre-cancer in women in Papua New Guinea: a prospective, single-arm intervention trial (HPV-STAT).

BACKGROUND: WHO recommends human papillomavirus (HPV) testing and same-day treatment for cervical screening in low-income and middle-income countries (LMICs); however, few published data exist on the validity of the strategy. We aimed to evaluate the clinical performance, treatment completion rates, adverse events profile, and acceptability of a fully integrated strategy, comprising point-of-care HPV DNA testing of self-collected specimens and same-day thermal ablation, for screening of cervical cancer in women in Papua New Guinea. METHODS: HPV-STAT was a large-scale, prospective, single-arm intervention trial conducted at two clinical sites in Papua New Guinea. Cervical screening clinics with an on-site consultant gynaecologist were selected in consultation with national and provincial health authorities, church health services, and local stakeholders. Eligible participants were women aged 30-59 years attending cervical screening services at the two clinics, who were willing to comply with study procedures and able to provide written informed consent. Women self-collected vaginal specimens for point-of-care GeneXpert testing (Cepheid, Sunnyvale, CA, USA) for oncogenic HPV types. Women testing positive for HPV underwent pelvic examination followed by same-day thermal ablation or referral for gynaecology review. All HPV-positive women and a 15% random sample of HPV-negative women provided a clinician-collected cervical specimen for liquid-based cytology. The primary outcome was clinical performance (ie, sensitivity, specificity, positive predictive value [PPV], and negative predictive value [NPV]) of the strategy for the detection of high-grade squamous intraepithelial lesion (HSIL) or worse. This trial is registered with ISRCTN, ISRCTN13476702. FINDINGS: Between June 5, 2018, and Jan 6, 2020, we recruited 4285 women, 3638 (84·9%) of whom tested negative for HPV and 647 (15·1%) tested positive for one or more oncogenic HPV type. Sensitivity of the algorithm to detect HSIL or worse was 85·4% (95% CI 81·0-89·6), with specificity 89·6% (88·6-90·6), PPV 35·2% (31·6-39·0), and NPV 98·9% (98·6-99·2). Among HPV-positive women, 602 (93·0%) received same-day thermal ablation and 42 (6·5%) were referred for gynaecology review, 37 (88·1%) of whom attended. Acceptability was high among both HPV-positive and HPV-negative women. Among the 329 HPV-positive women who attended a 3-month follow-up visit, 51 (15·5%) reported mild adverse symptoms that resolved in all cases by the follow-up visit. There were no serious adverse events. INTERPRETATION: We conducted the first real-world evaluation of a fully integrated point-of-care HPV self-collect, test, and treat strategy for same-day cervical screening in a LMIC and found it to be effective, acceptable, and safe when implemented at scale in primary health-care facilities in Papua New Guinea. Our findings support the introduction and scale-up of HPV screening and treatment for the control and elimination of cervical cancer in LMICs, as recommended by WHO. FUNDING: Australian National Health and Medical Research Council.

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.

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.

Strategies to reduce and maintain low perinatal mortality in resource-poor settings - Findings from a four-decade observational study of birth records from a large public maternity hospital in Papua New Guinea.

BACKGROUND: In many low- to middle-income countries (LMIC) assisted vaginal birth rates have fallen, while caesarean section (CS) rates have increased, with potentially deleterious consequences for maternal and perinatal mortality. AIMS: To review birth mode and perinatal mortality in a large LMIC hospital with strict labour management protocols and expertise in vacuum extraction. MATERIALS AND METHODS: We conducted a retrospective observational study at Port Moresby General Hospital in Papua New Guinea. Birth registers from 1977 to 2015 (39 years) were reviewed. Overall and modified (fresh stillbirths and early neonatal deaths ≥500 g) perinatal mortality rates (PMRs) were calculated by birthweight/birth mode. RESULTS: There were 365 056 births (5215 in 1977; 14 927 in 2015), of which 14 179 (3.9%) were vacuum extractions, 609 (0.2%) forceps births and 14 747 (4.4%) CS (increase from 2% to 5%). The failure rate of vacuum extraction was 2.5% (range 0.5-5.4%). Symphysiotomy was employed for 184 births. From 1989 to 2015, the modified mean PMR for babies ≥2500 g was 8.1/1000 births (range 5.6-12.1; 6.9 in 2015), 9.1/1000 for babies ≥1500 g (7.3-14.8; 9.1 in 2015) and 7.5/1000 (0-21.7; 9.0 in 2015) for vacuum extractions (98% were ≥2500 g). The overall PMR for these years was 29.7/1000 births. CONCLUSIONS: In an LMIC with rapidly increasing birth numbers a comparatively low PMR can be achieved while maintaining low CS rates. This may be in part accomplished through strict use of second-stage protocols, perinatal audit, and supportive training that promotes judicious and proficient use of vacuum extraction and CS.

Performance of clinical screening algorithms comprising point-of-care HPV-DNA testing using self-collected vaginal specimens, and visual inspection of the cervix with acetic acid, for the detection of underlying high-grade squamous intraepithelial lesions in Papua New Guinea.

The performance of different clinical screening algorithms comprising point-of-care HPV-DNA testing using self-collected vaginal ('V') specimens, and visual inspection of the cervix with acetic acid (VIA) was evaluated in Papua New Guinea. Women aged 30-59 years provided V specimens that were tested at point-of-care using the Xpert HPV Test (Cepheid, Sunnyvale, CA). A clinician-collected cervical ('C') specimen was then collected for point-of-care Xpert testing, and liquid-based cytology (LBC). Following this, VIA examination was conducted, blind to HPV test results, and ablative cervical cryotherapy provided if indicated. Detection of high-grade squamous intraepithelial lesion (HSIL) by LBC was the reference standard used to evaluate clinical screening algorithms. Of 1005 women, 36 had HSIL+. Xpert HPV Test performance using V specimens (sensitivity 91.7%, specificity 87.0%, PPV 34.0%, NPV 99.3%) was superior to VIA examination alone (51.5%, 81.4%, 17.5%, 95.6% respectively) in predicting underlying HSIL+. A screening algorithm comprising V specimen HPV testing followed by VIA examination had low sensitivity (45.5%) but comparable specificity, PPV and NPV to HPV testing alone (96.3%, 45.5%, 96.3% respectively). A 'test-and-treat' screening algorithm based on point-of-care HPV testing of V specimens had superior performance compared with either VIA examination alone, or a combined screening algorithm comprising HPV testing plus VIA.

Association between visual inspection of the cervix with acetic acid examination and high-risk human papillomavirus infection, Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis in Papua New Guinea.

BACKGROUND: Papua New Guinea (PNG) has among the highest estimated burdens of cervical cancer globally but currently has no national cervical screening program. Visual inspection of the cervix with acetic acid (VIA) is a low-cost screening strategy endorsed by the World Health Organization that has been adopted in many low-resource settings but not previously evaluated in PNG. AIM: To evaluate the association between VIA examination findings and high-risk HPV (hrHPV) infection; and the impact of concomitant genital Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis on the interpretation of VIA findings. METHODS: A prospective clinical cohort study among women aged 30-59 years attending Well Woman Clinics in PNG. Main outcome measures were VIA examination findings and laboratory-confirmed hrHPV, C. trachomatis, N. gonorrhoeae and T. vaginalis. RESULTS: A total of 614 women were enrolled, of whom 87.5% (537/614) underwent VIA, and 12.5% (77/614) did not due to pre-existing cervicitis or inability to visualise the transformation zone. Among the 537 women who underwent VIA, 21.6% were VIA positive, 63.7% VIA negative, and 14.7% had indeterminate findings. The prevalence of hrHPV infection (n = 614) was 14.7%; C. trachomatis, 7.5%; N. gonorrhoeae, 8.0%; and T. vaginalis, 15.0%. VIA positive women were more likely to have HPV16 (odds ratio: 5.0; 95%CI: 1.6-15.6; P = 0.006) but there was no association between HPV18/45, all hrHPV types (combined), C. trachomatis, N. gonorrhoeae or T. vaginalis. CONCLUSIONS: VIA positivity was associated with HPV16, but not with other hrHPV infections, nor with genital C. trachomatis, N. gonorrhoeae or T. vaginalis in this setting.

Programmes for the prevention of parent-to-child transmission of HIV in Papua New Guinea: Health system challenges and opportunities.

BACKGROUND: Prevention of parent-to-child transmission (PPTCT) of HIV is a highly complex package of interventions, which spans services in both maternal and child health programmes. In Papua New Guinea (PNG), a commitment to ensure that all pregnant women and their partners have access to the full range of PPTCT interventions exists; however, efforts to increase access and utilisation of PPTCT remain far from optimal. The aim of this paper is to examine health care worker (HCW) perception of health system factors impacting on the performance of PPTCT programmes. METHOD: Sixteen interviews were undertaken with HCWs involved in the PPTCT programme. Application of the WHO 6 building blocks of a health system was applied, and further thematic analysis was conducted on the data with assistance from the analysis software NVivo. RESULTS: Broken equipment, problems with access to medication and supplies, and poorly supported workforce were reported as barriers for implementing a successful PPTCT programme. The absence of central coordination of this complex, multistaged programme was also recognised as a key issue. CONCLUSION: The study findings highlight an important need for investment in appropriately trained and supported HCWs and integration of services at each stage of the PPTCT programme. Lessons from the PPTCT experience in PNG may inform policy discussions and considerations in other similar contexts.

Performance of syndromic management for the detection and treatment of genital Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis among women attending antenatal, well woman and sexual health clinics in Papua New Guinea: a cross-sectional study.

OBJECTIVE: Papua New Guinea (PNG) has among the highest estimated prevalences of genital Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) of any country in the Asia-Pacific region. Diagnosis and treatment of these infections have relied on the WHO-endorsed syndromic management strategy that uses clinical presentation without laboratory confirmation to make treatment decisions. We evaluated the performance of this strategy in clinical settings in PNG. DESIGN: Women attending antenatal (ANC), well woman (WWC) and sexual health (SHC) clinics in four provinces were invited to participate, completed a face-to-face interview and clinical examination, and provided genital specimens for laboratory testing. We estimated the performance characteristics of syndromic diagnoses against combined laboratory diagnoses. RESULTS: 1764 women were enrolled (ANC=765; WWC=614; SHC=385). The prevalences of CT, NG and TV were highest among women attending ANC and SHC. Among antenatal women, syndromic diagnosis of sexually transmitted infection had low sensitivity (9%-21%) and positive predictive value (PPV) (7%-37%), but high specificity (76%-89%) and moderate negative predictive value (NPV) (55%-86%) for the combined endpoint of laboratory-confirmed CT, NG or TV. Among women attending WWC and SHC, 'vaginal discharge syndrome' had moderate to high sensitivity (72%-78%) and NPV (62%-94%), but low specificity (26%-33%) and PPV (8%-38%). 'Lower abdominal pain syndrome' had low sensitivity (26%-41%) and PPV (8%-23%) but moderate specificity (66%-68%) and high NPV (74%-93%) among women attending WWC, and moderate-high sensitivity (67%-79%) and NPV (62%-86%) but low specificity (26%-28%) and PPV (14%-33%) among SHC attendees. CONCLUSION: The performance of syndromic management for the detection and treatment of genital chlamydia, gonorrhoea and trichomonas was poor among women in different clinical settings in PNG. New diagnostic strategies are needed to control these infections and to prevent their adverse health outcomes in PNG and other high-burden countries.

Prevalence and risk factors of Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and other sexually transmissible infections among women attending antenatal clinics in three provinces in Papua New Guinea: a cross-sectional survey.

Background Papua New Guinea (PNG) is estimated to have among the highest prevalences of HIV and sexually transmissible infections (STIs) of any Asia-Pacific country, and one of the highest burdens of maternal syphilis globally. The prevalence of curable STIs, such as Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV), among pregnant women in PNG is relatively unknown. METHODS: A cross-sectional bio-behavioural survey to investigate the epidemiology of CT, NG, TV and other STIs among pregnant women in three provinces of PNG was undertaken. Women aged 18-35 years attending their first antenatal clinic visit were invited to participate. Participants completed a short interview and provided self-collected vaginal specimens for CT, NG and TV laboratory-based nucleic acid amplification tests and a venepuncture specimen for laboratory testing for syphilis and Herpes simplex virus type-2 (HSV-2) serology. Routine antenatal assessment was conducted according to national guidelines, including HIV counselling and testing and point-of-care syphilis screening. RESULTS: A total of 765 women were enrolled. Overall, 43% (95% confidence interval (CI): 39.2-46.4) had one or more of CT, NG or TV infection. CT was the most prevalent STI (22.9%, 175/765; 95% CI: 19.9-25.9), followed by TV (22.4%, 171/765; 95% CI: 19.4-25.4), and NG (14.2%, 109/765; 95% CI: 11.7-16.7). The prevalence of active syphilis was 2.2% (17/765; 95% CI: 1.2-3.3), HSV-2 was 28.0% (214/765; 95% CI: 24.8-31.2) and HIV, 0.8% (6/765; 95% CI: 0.2-1.4). Prevalences were highest among primigravid women, women aged <25 years, and among those in Central Province. CONCLUSION: High prevalences of curable genital STIs were observed among women attending routine antenatal clinic services in PNG. These infections have been associated with adverse pregnancy outcomes and could be important contributors to poor maternal and neonatal health in this setting.

Hospital admission following induced abortion in Eastern Highlands Province, Papua New Guinea--a descriptive study.

BACKGROUND: In Papua New Guinea abortion is restricted under the Criminal Code Act. While safe abortions should available in certain situations, frequently they are not available to the majority of women. Sepsis from unsafe abortion is a leading cause of maternal mortality. Our findings form part of a wider, mixed methods study designed to identify complications requiring hospital treatment for post abortion care and to explore the circumstances surrounding unsafe abortion. METHODS: Through a six month prospective study we identified all women presenting to the Eastern Highlands Provincial Hospital following spontaneous and induced abortions. We undertook semi-structured interviews with women and reviewed individual case notes, extracting demographic and clinical information. FINDINGS: Case notes were reviewed for 56% (67/119) of women presenting for post abortion care. At least 24% (28/119) of these admissions were due to induced abortion. Women presenting following induced abortions were significantly more likely to be younger, single, in education at the time of the abortion and report that the baby was unplanned and unwanted, compared to those reporting spontaneous abortion. Obtained illegally, misoprostol was the method most frequently used to end the pregnancy. Physical and mechanical means and traditional herbs were also widely reported. CONCLUSION: In a country with a low contraceptive prevalence rate and high unmet need for family planning, all reproductive age women need access to contraceptive information and services to avoid, postpone or space pregnancies. In the absence of this, women are resorting to unsafe means to end an unwanted pregnancy, putting their lives at risk and putting an increased strain on an already struggling health system. Women in this setting need access to safe, effective means of abortion.

A randomised controlled trial of two instruments for vacuum-assisted delivery (Vacca Re-Usable OmniCup and the Bird anterior and posterior cups) to compare failure rates, safety and use effectiveness.

BACKGROUND: Most previous trials of vacuum-assisted delivery have been in settings with high rates of instrumental vaginal delivery (8-12%) and high rates of failure to deliver with the intended instrument (20-30%). Over the past 20 years, vacuum-assisted delivery rates at the Port Moresby General Hospital have been 3-4% with failure rates of <3%. OBJECTIVE: The objective is to compare the failure rates of two vacuum extractor instruments, the Vacca Re-Usable Omnicup and the Bird Vacuum delivery system (anterior and posterior cups). SETTING: Port Moresby General national referral and teaching Hospital (PMGH), Papua New Guinea. POPULATION: Two hundred consecutive women requiring assisted delivery, June-December, 2007. METHODS: When a woman required an assisted delivery, she was randomised into either the Vacca Re-Usable Omnicup (Clinical Innovations Inc.) or Bird anterior or posterior metal cup (depending upon the position of the vertex). One hundred women were randomised to each vacuum device. Statistical analysis was on 'an intention-to-treat' basis. MAIN OUTCOME MEASURES: The main outcome measure was the successful completion of the delivery with the allocated instrument. Secondary outcomes were maternal trauma (episiotomy and trauma to the maternal genital tract), significant scalp trauma (sub-galeal haemorrhage or serious abrasion) and fetal and neonatal outcomes (Apgar score less than seven at 5 minutes, days spent in the Special Care Nursery and neonatal death). RESULTS: Failure rates for both Omnicup (2/100) and Bird metal cups (6/100) were not statistically different (RR 1.05, 95% CI 0.99-1.12; P = 0.17). Rates of maternal trauma and fetal scalp trauma were similar in both groups. CONCLUSION: Both the Vacca re-useable Omnicup and the Bird metal cups are very effective instruments to achieve successful assisted delivery and equally so. Failures and problems were associated with not applying the vacuum cup to the flexion point on the fetal scalp and the mechanical faults with vacuum equipment devices.

A review of the current state of malaria among pregnant women in Papua New Guinea.

Besides young children, pregnant women are at high risk of malaria in highly endemic countries. This paper reviews evidence from studies conducted in Papua New Guinea (PNG) in the last 20 years on the burden and prevention of malaria in pregnancy and highlights gaps in our knowledge of malaria in pregnancy in PNG. Overall, primigravidae were found to be at higher risk than multigravidae, with up to 40% of primigravidae but only 10-25% of multigravidae infected with Plasmodium falciparum at delivery. Such infections were found to be associated with a 128-145 g decrease in birthweight. Mean birthweights reported between 1980 and 2003 range from 2.58 to 2.72 kg in primigravidae and 2.84 to 3.09 kg in multigravidae, with 21% to 48% and 9% to 19% of babies born to primigravidae and multigravidae, respectively, of low birthweight (<2500 g). The negative impact of malaria in pregnancy is compounded by relatively low rates of antenatal coverage. The current PNG national treatment policy which prescribes a treatment course of first-line antimalarial treatment (currently chloroquine and sulphadoxine-pyrimethamine) at first antenatal clinic contact, followed by weekly chloroquine prophylaxis and iron and folate supplementation, may no longer be effective given the high levels of resistance to chloroquine in PNG and poor compliance. In order to reduce the burden of malaria in pregnancy in PNG, alternative methods of control such as insecticide-treated nets and intermittent preventive treatment in pregnancy (IPTp), as well as improved modes of delivery of maternal health interventions, are urgently needed.

A case-control study of VDRL-positive antenatal clinic attenders at the Port Moresby General Hospital Antenatal Clinic and Labour Ward to determine outcomes, sociodemographic features and associated risk factors.

Between June 2001 and December 2002, 152 antenatal patients at Port Moresby General Hospital who were Venereal Disease Research Laboratory (VDRL) serology positive and 150 unselected antenatal patients who tested negative were studied to determine the gestational age at which the tests were performed, the time it took for results to become available, the proportion of patients who received treatment, the sociodemographic characteristics associated with VDRL positivity and the effect of VDRL positivity on maternal and perinatal outcomes. The prevalence rate of VDRL positive among antenatal clinic attenders in Port Moresby at that time was 4.4%. Of the 152 VDRL-positive patients in this study 97% were also Treponema pallidum haemagglutination (TPHA) positive. Significantly more of the positive patients were of highlands origin, lived in settlements, had previous marriages, had lower parities, delivered preterm babies, had stillbirths, had growth-restricted babies and had babies with lower Apgar scores at both 1 and 5 minutes. The mean birthweight was significantly lower among the positive patients. Significantly more of the positive patients were married to spouses with occupations which were regarded as 'risky' for sexually transmitted infections. There was no difference between the two groups with respect to patient's education, marital status, husband's education, gestational age at delivery and the number of days the baby spent in the Special Care Unit. The study concluded that the current antenatal screening does not provide adequate coverage for our patients. If the current availability of clinic-based strip tests provided by a non-government organization can be continued by the Ministry of Health we should be able to overcome this problem.

Factors associated with success or failure in trials of vacuum extraction.

Failure rates for vacuum extraction of between one in 16 and one in 600 have been reported. Most studies report that unexpected failure carries a greater risk to both mother and fetus. The aim of this study was to determine factors that were likely to predict success or failure in trials of vacuum extraction. At the Port Moresby General Hospital, 59 trials of vacuum extraction were performed between 1 December 1997 and 30 November 1999. These cases were analysed according to whether vacuum extraction was achieved with more than or less than three pulls, or an alternative method of delivery was required to effect delivery Factors that were predictive of failure were: (i) Highlands origin of the mother; (ii) longer duration of the second stage of labour; (iii) severe moulding of the fetal head; (iv) cup detachments and deflexing cup applications; and (v) operator persisting with the procedure after three pulls. The cervix being less than fully dilated when the trial was commenced was not associated with a higher risk of failure, nor was it associated with a significantly higher risk of cervical trauma. Perinatal death and serious fetal scalp trauma were associated with deflexing cup applications, making more than three pulls and failed vacuum extractions.