Effect of a labor triage checklist and ultrasound on obstetric referral at three primary health centers in Eastern Uganda

Objective: To test whether introduction of a midwife-performed triage checklist and focused ultrasound improves diagnosis and referral for obstetric conditions, including multiple gestation, placenta previa, oligohydramnios, preterm birth, malpresentation, and abnormal fetal heart rate. Methods: We implemented an intake log (Phase 1), a checklist (Phase 2), and a checklist plus ultrasound scan (Phase 3) at three primary health centers in Eastern Uganda for women presenting in labor. Intake diagnoses, referral status, and delivery outcomes were assessed, as well as sensitivity and positive predictive value (PPV). Results: Between February 2018 and July 2019, 1155, 961, and 603 women were enrolled across the three phases (n=2719); 2339 had outcome data. Incidence of any outcome-confirmed condition was 8.8%, 7.9%, and 7.1% (P=0.526) for each phase, respectively. The proportion of referred women with a condition did not change between Phases 1 and 2 (7.8% versus 8.6%, P=0.855), but increased in Phase 3 (48.4%, P<0.001). Sensitivity improved with each intervention; PPV decreased with ultrasound. Conclusion: Use of ultrasound plus checklist increased referrals and sensitivity for high-risk conditions, with decreased PPV. The checklist alone improved correct diagnosis, but not referral. Further evaluation of these triage interventions to maximize diagnostic accuracy, referral decisions, and outcomes are warranted. We examined the phased implementation of triage interventions at three PHCs in Busoga region, Uganda, between February 2018 and July 2019. In 2016, 60% of Ugandan women received four prenatal care visits and the median length of pregnancy at entry to prenatal care was 4.7 months. 13 The three study PHCs provide 24‐hour delivery services without cesarean delivery capacity, conduct 60–75 monthly deliveries, and are located 11, 25, and 41 km from the DH. On average, each PHC has five midwives on staff with each shift covered by one midwife in the labor room and another in prenatal care. The standard of care guidance is to refer to higher care for the conditions of interest (detailed below) unless delivery is imminent. Other conditions including obstructed/prolonged labor, previous cesarean section, pre‐eclamptic toxemia, and antepartum hemorrhage, also warrant referral. Ambulances are accessible, but patients pay money for fuel or rely on their own means to reach the DH. Ultrasounds were not available before the study. The study’s primary outcome was the proportion of women with one or more of six high‐risk conditions confirmed at birth who were referred upon initial PHC presentation. The conditions (preterm birth, multiple gestation, oligohydramnios, placenta previa, malpresentation, and abnormal fetal heart rate) were combined into one composite variable for the primary analysis. The following criteria were used to confirm presence of a complication at outcome: multiple gestation, more than one fetus present; preterm birth, gestational age by Ballard examination; oligohydramnios, reduced amniotic fluid at birth without rupture of membranes; placenta previa, if reported by vaginal examination or cesarean section; malpresentation, non‐cephalic presenting fetal part; abnormal fetal heart rate, 1‐minute Apgar scores less than 7 or infant born without signs of life. The study interventions are described in Table ​Table1.1. The study evaluated the effect of Phase 2 and Phase 3 interventions on the primary outcome using Phase 1 as the baseline comparison. Phase 1 introduced a triage intake log and outcome form. In Phase 2, standardized documentation was supplemented with a triage checklist and referral support. Ultrasound (Mindray DP‐10, Mindray, Shenzhen, China) was added in Phase 3. Phase 2 and Phase 3 checklists are provided in the Appendix S1. Documentation, checklist, and ultrasound were also introduced at the referral DH, as part of a concurrent study that will be described elsewhere. The ultrasound curriulum and quality assurance activites are published elsewhere. 14 Description of triage interventions introduced at the three primary health centers (PHCs) during each study phase. Women who presented with labor‐like pains after 28 weeks of pregnancy were eligible. Women were excluded if they were not in labor or required immediate intervention, such as those with severe antepartum hemorrhage, eclamptic seizure, or imminent delivery. We designed a balanced study with an equal number of women per phase. We estimated that 4% of all parturient women were referred for one of the six conditions based on baseline assessment of register data. Given a two‐tailed test, α of 0.05, 80% power, and a relative effect of 100% (from 4% to 8%), the study required 601 women across the three PHCs per phase (Fleiss continuity correction applied). The sample size was increased by 20%, to 721 per phase, to account for loss to follow up, refusal, and missing data. For each phase, three midwives and one study research nurse from each PHC were trained in study procedures. One study‐trained midwife covered each shift with support from the research nurse. Tools were piloted and revised before implementation. Study‐trained midwives filled out paper‐based study tools and related clinical data sources (i.e., medical charts, register). Research nurses identified eligible women, obtained informed written consent, and entered data using tablets into open data kit. They verified data completeness and consistency before entering data electronically. The study data manager performed biweekly data quality spot‐checks, transferred data to a secure server, and obtained monthly counts of admissions and deliveries to estimate enrollment rates. Paper forms were kept in secure cabinets. All devices were encrypted and password protected, and all electronic data were kept on secure systems. Data access was limited to designated study staff, including the open data kit server, which was hosted by University of California San Francisco. SPSS v25.0 (IBM, Armonk, NY, USA) was used to conduct range and logic checks, and to clean and analyze the data. Individual‐level data from the intake log, outcome form, and Phase 2 and Phase 3 checklists were linked by unique study identification numbers and inpatient numbers. Bivariate analyses included χ2 tests or Fisher’s exact statistics for categorical data and Student’s t tests for continuous data. Conditions were examined using composite variables. Any maternal condition comprises conditions that were measured once per pregnancy (multiple gestation, preterm birth, oligohydramnios, placenta previa). Any fetal condition comprises conditions that were measured per fetus for both singleton and multiple gestations (malpresentation, abnormal fetal heart rate). Any maternal or fetal condition is a composite variable for the six conditions used for the primary analysis. Data for individual conditions are presented without P values to avoid over‐interpretation. Logistic regression was used to adjust for covariates. We ascertained sensitivity and positive predictive value (PPV), as well as specificity and negative predictive value. As secondary outcomes, without a priori hypotheses, descriptive analyses without multiple comparison adjustments were conducted. All participants provided voluntary written informed consent. Approvals were obtained from University of California San Francisco’s Institutional Review Board (#17‐23310) and the Higher Degrees, Research and Ethics Committee at Makerere University (#515).