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Randomized Controlled Trial
Single dose v two-dose antenatal anti-D prophylaxis: a randomised controlled trial.
- Scott W White, Janice C Cheng, Blagica Penova-Veselinovic, Carol Wang, Melanie White, Bernie Ingleby, Christine Arnold, and Craig E Pennell.
- University of Western Australia, Perth, WA.
- Med. J. Aust. 2019 Sep 1; 211 (6): 261-265.
ObjectiveTo compare rates of detectability of circulating Rh(D)-immunoglobulin (anti-D) at delivery with single and two-dose antenatal anti-D prophylaxis (RAADP) regimens; to compare compliance with the two regimens.DesignOpen label, randomised controlled trial between May 2013 and November 2015.Setting, Participants277 women who attended a tertiary obstetric referral hospital in Perth for antenatal care and were at least 18 years of age, less than 30 weeks pregnant and yet to receive RAADP, Rh(D)-negative (negative antibody screen), and who intended to deliver their baby at the hospital. Exclusion criteria were prior anti-D sensitisation, any contraindication of anti-D administration, and a history of isolated IgA deficiency.InterventionsOne 1500 IU anti-D dose at 28 weeks of pregnancy (single dose regimen); two doses of 625 IU each at 28 and 34 weeks of pregnancy (two-dose regimen).Main Outcome MeasuresThe primary outcome was the proportion of women with detectable anti-D levels at delivery; the secondary outcome was compliance with the allocated RAADP regimen.ResultsCirculating anti-D was detectable at delivery in a greater proportion of women in the two-dose group (111 of 129, 86%) than in the single dose group (70 of 125, 56%; P < 0.001). Compliance was not significantly different between the single dose (86 of 138, 61%) and two-dose groups (70 of 139, 50%; P = 0.06).ConclusionsThe two-dose RAADP schedule currently recommended in Australia provides better protection against Rh(D) sensitisation than a one-dose regimen.Trial RegistrationAustralian and New Zealand Clinical Trials Registry (ACTRN12613000661774).© 2019 AMPCo Pty Ltd.
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