1. Preterm birth 2. Low birth weight Pregnancy and Childbirth
Conditions
Interventions
The unit of randomisation is a primary health care clinic and its catchment communities. Ten geographically distinct clusters will be assigned in a 1:1 ratio to control and intervention arms. Each par
Sponsors
Papua New Guinea Institute of Medical Research
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Aged 16 years or over at time of enrolment visit 2. Attending first antenatal clinic visit 3. Estimated gestational age 26 weeks or below based on obstetric ultrasound examination at first antenatal clinic visit 4. Able to complete study informed consent procedures; to understand why the study is being carried out, and the potential risks and benefits associated with study participation 5. Willing to undergo a clinical assessment including ultrasound examination; to provide urine or self-collected vaginal swabs for STI testing; and to comply with study follow-up procedures, including a postnatal visit within 72 hours of birth for the measurement of primary outcome data 6. Live within approximately one hour drive of participating study clinic 7. Able to provide reliable contact details to facilitate future community tracing and postnatal follow-up
Exclusion criteria
Exclusion criteria: 1. Severe, symptomatic anaemia identified during the enrolment visit that requires hospitalisation (Hb <6 g/dl accompanied by symptoms requiring urgent treatment) 2. Permanent disability, that prevents or impedes study participation and/or comprehension (such that it is not possible to obtain informed consent to participate)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of women and their newborns who experience preterm birth and/or low birth weight, measured within 72 hours in both trial arms. 1. Preterm birth: The classification of infants as preterm or low birth weight relies on accurate assessment of gestational age. Following best practice, an obstetric ultrasound examination will be carried out by a trained member of the research team to estimate gestational age, as used earlier by our team (Study 3). Findings will be compared with self-reported date of last menstrual period, and pregnancies re-dated according to recommended procedures. The proportion of women experiencing a preterm birth (< 37 weeks gestation) in each trial phase will be calculated by comparing the estimated gestational age (measured at enrolment) with the date and time of birth (measured at the postnatal visit). 2. Low birth weight: Calibrated, medical grade infant weighing scales accurate to within 10g will be used, two weight readings taken 5-10 minutes apart, and the date and time of each recording noted. The time between the second measurement and estimated time of birth will be used to indicate delay between birth and weight measurement in each case. The mean of the two weight measurements will be used to calculate the proportion of low birth weight newborns (< 2500g) in each trial arm. The inclusion of birth weight data in the primary outcome will be censored at 72 hours of birth: weight measurements after 72 hours but within 1 week of birth will be categorised as ‘late birth weights’ and will not be included with primary outcome data but will be analysed separately. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean birth weight: calculated within 72 hours of birth in the intervention and control arms of the trial from primary outcome data 2. Premature rupture of membranes: interviews with women during antenatal visits, in labour and/or during the postnatal assessment will be used to establish the timing of rupture of membranes and whether this occurred prior to the onset of labour. The timing of membrane rupture will be calculated using client-held health books and study records. The proportion of women in each trial arm who experience membrane rupture prior to the onset of labour will then be calculated. 3. Curable STIs diagnosed and treated: the number of women with chlamydia, gonorrhoea or trichomonas (or a combination of these infections) at their first antenatal visit in the control arm will be determined by Xpert™ testing of stored urine specimens. The proportion of those correctly diagnosed and appropriately treated will then be calculated and compared to the proportion diagnosed and treated in the intervention arm. 4. Cost-effectiveness: incremental cost-effectiveness ratios (ICERs) will be calculated for three outcomes (preterm birth, low birth weight and STIs diagnosed and treated) using cost data sourced from health facilities, and health service clients. Long term outcomes will also be modelled as cost per life year saved and cost per DALY averted 5. Health system implementation requirements: quantitative client and health staff CRF data, and qualitative semi-structured interview (SSI) findings, will be used to identify health system implementation challenges and benefits. These are likely to include patient-flow and turnaround-time; work-flow and staff time; training and supervision needs; procedures for finance, payment and health information; community engagement; and shifts in client-provider relationships. 6. Acceptability of antenatal point-of-care STI testing and treatment: client and health staff CRF data will provide quantitative measures of acc | — |
Countries
Papua New Guinea
Outcome results
None listed