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The trial was conducted between June 2010 and August 2013 at seven sites across four countries, namely Burkina Faso, Ghana, Malawi and Zambia (Clin code: NCT00852423).Eligible patients were randomized to one of four treatment arms and followed up weekly until day 63 and then again at delivery.SFH measurement was undertaken at enrolment using a non-elastic tape measure.
This included centrally purchased equipment, a standard operating procedure (SOP) which was applicable and mandatory across all sites (Additional file 1), two specifically dedicated staff per site to carry out all US measurements and central training before study start.However, correlations varied considerably in between countries (Table 2 & Fig. The mean difference between US and any of the other methods was less than 1 week overall (LMP: 0.34 weeks, SFH: 0.40 weeks, BS: 0.80 weeks) but showed great intercountry variations (Table 2 & Fig. The 95% limits of agreement were considerable (LMP:-7.9 to 8.6 weeks, SFH: − 4.9 to 5.8 weeks, BS: − 3.5 to 5.1 weeks) and again showed great variation in the different countries (Table 2 & Fig. The sensitivity analyses including women ≥24 weeks’ gestation at enrolment into the study showed results consistent with the main analyses for BS with mean difference of 0.66 weeks (Pearson r = 0.27, 95% limit of agreement − 4.1to 5.4, range of averages 27.29–43.21) and higher mean differences for LMP with 1.15 weeks (Pearson r = 0.33; 95% limit of agreement − 7.9 to 10.1, range of averages 25.21–50.14 weeks) and SFH with 0.89 weeks (Pearson r = 0.63, 95% limit of agreement − 4.9 to 6.3, range of averages 22.14–46.85 weeks).Using ultrasound as the reference, 1391 mothers delivered term babies compared to 239 preterm babies ( 24 weeks gestational age at enrolment the sensitivity analyses showed no major difference in trends with regards to agreement between methods for BS but showed higher mean difference in weeks for SFH suggesting an increasing variation .Periodical training was delivered on site by experienced obstetricians and internal QC measures conducted at each site.This included repeated measurements every first week of the month by the second trained staff member and every third week by repeated measurements of one patient.