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All statistical analyses were done using Stata v14 (Stata Corp, USA).
For the purpose of this analysis, women with a gestational age 24 weeks at enrolment, where the birth date of the baby was not documented, who had twins, miscarriages or stillbirths were excluded.
We assessed the accuracy of LMP, SFH, and BS to estimate gestational age at delivery and preterm birth compared to ultrasound (US) using a large dataset derived from a randomized controlled trial in pregnant malaria patients in four African countries.
Mean and median gestational age for US, LMP, SFH and BS were calculated for the entire study population and stratified by country.
The mean maternal age at recruitment was 22.3 years (95%CI: 22.1–22.6), with the lowest mean age of 20.6 years (95%CI: 20.2–21.1) in Zambia and the highest with 24.5 years (95%CI: 23.8–25.2) in Ghana (p Results from BS were available for 93.5% (n = 1520) babies, results from SFH for 99.6% (n = 1624) mothers and LMP for 24.8% (n = 404) of enrolled women.
The mean gestational age at delivery using US was 38.7 weeks (95%CI: 38.6–38.8, median: 38.9 weeks, range: 23.1–44.8 weeks), by LMP was 38.4 weeks (95%CI: 38.0–38.9, median: 38.7 weeks, range: 22.9–60.9 weeks), by SFH was 38.3 weeks (95%CI: 38.2–38.5, median: 38.3 weeks, range: 21.1–49.7 weeks) and by BS was 38.0 weeks (95%CI: 37.9–38.1, median: 38.0 weeks, range: 28.0–42.0) (p Correlation between US and any of the other three methods was poor to moderate (LMP: r = 0.38, SFH: r = 0.63, BS: r = 0.31).
Additional analysis was performed using 32 weeks as a cut-off to define very preterm babies.The methods of the trial, including details on quality assurance and quality control are described in detail elsewhere , as well as the results of the main outcomes .Since only women in the second or third trimester were eligible into the study, gestational age at enrolment was determined using diagnostic ultrasound (US) imaging equipment (FFSonic UF-4100) with a 3.5 MHz transducer for transabdominal examination normally and a 5 MHz transducer for very thin women.The mean gestational age at delivery using US was 38.7 weeks (95%CI: 38.6–38.8), by LMP, 38.4 weeks (95%CI: 38.0–38.9), by SFH, 38.3 weeks (95%CI: 38.2–38.5), and by BS 38.0 weeks (95%CI: 37.9–38.1) (p This assessment was conducted in the framework of an open label, randomized controlled clinical trial to assess the efficacy and safety of four different artemisinin-combination therapies in women presenting with P.falciparum malaria in the second and third trimester of pregnancy.
In a sensitivity analysis women ≥24 weeks gestational age at enrolment were included.