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, Craig E. Pennell

Research output: Contribution to journalArticle

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Abstract

Objective: To 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. Design: Open label, randomised controlled trial between May 2013 and November 2015. Setting, participants: 277 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. Interventions: One 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 measures: The primary outcome was the proportion of women with detectable anti-D levels at delivery; the secondary outcome was compliance with the allocated RAADP regimen. Results: Circulating 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). Conclusions: The two-dose RAADP schedule currently recommended in Australia provides better protection against Rh(D) sensitisation than a one-dose regimen. Trial registration: Australian and New Zealand Clinical Trials Registry (ACTRN12613000661774).

Original languageEnglish
JournalMedical Journal of Australia
DOIs
Publication statusPublished - 14 Jul 2019

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Randomized Controlled Trials
Rho(D) Immune Globulin
Rh Isoimmunization
IgA Deficiency
Pregnancy
Prenatal Care
New Zealand
Tertiary Care Centers
Compliance
Obstetrics
Registries
RHO(D) antibody
Appointments and Schedules
Outcome Assessment (Health Care)
Clinical Trials
4-ribitylamino-5-amino-2,6-dihydroxypyrimidine
Antibodies

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White, Scott W. ; Cheng, Janice C. ; Penova-Veselinovic, Blagica ; Wang, Carol ; White, Melanie ; Ingleby, Bernie ; Arnold, Christine ; Pennell, Craig E. / Single dose v two-dose antenatal anti-D prophylaxis : a randomised controlled trial. In: Medical Journal of Australia. 2019.
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abstract = "Objective: To 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. Design: Open label, randomised controlled trial between May 2013 and November 2015. Setting, participants: 277 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. Interventions: One 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 measures: The primary outcome was the proportion of women with detectable anti-D levels at delivery; the secondary outcome was compliance with the allocated RAADP regimen. Results: Circulating 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). Conclusions: The two-dose RAADP schedule currently recommended in Australia provides better protection against Rh(D) sensitisation than a one-dose regimen. Trial registration: Australian and New Zealand Clinical Trials Registry (ACTRN12613000661774).",
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Single dose v two-dose antenatal anti-D prophylaxis : a randomised controlled trial. / White, Scott W.; Cheng, Janice C.; Penova-Veselinovic, Blagica; Wang, Carol; White, Melanie; Ingleby, Bernie; Arnold, Christine; Pennell, Craig E.

In: Medical Journal of Australia, 14.07.2019.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Single dose v two-dose antenatal anti-D prophylaxis

T2 - a randomised controlled trial

AU - White, Scott W.

AU - Cheng, Janice C.

AU - Penova-Veselinovic, Blagica

AU - Wang, Carol

AU - White, Melanie

AU - Ingleby, Bernie

AU - Arnold, Christine

AU - Pennell, Craig E.

PY - 2019/7/14

Y1 - 2019/7/14

N2 - Objective: To 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. Design: Open label, randomised controlled trial between May 2013 and November 2015. Setting, participants: 277 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. Interventions: One 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 measures: The primary outcome was the proportion of women with detectable anti-D levels at delivery; the secondary outcome was compliance with the allocated RAADP regimen. Results: Circulating 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). Conclusions: The two-dose RAADP schedule currently recommended in Australia provides better protection against Rh(D) sensitisation than a one-dose regimen. Trial registration: Australian and New Zealand Clinical Trials Registry (ACTRN12613000661774).

AB - Objective: To 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. Design: Open label, randomised controlled trial between May 2013 and November 2015. Setting, participants: 277 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. Interventions: One 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 measures: The primary outcome was the proportion of women with detectable anti-D levels at delivery; the secondary outcome was compliance with the allocated RAADP regimen. Results: Circulating 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). Conclusions: The two-dose RAADP schedule currently recommended in Australia provides better protection against Rh(D) sensitisation than a one-dose regimen. Trial registration: Australian and New Zealand Clinical Trials Registry (ACTRN12613000661774).

KW - Fetal medicine

KW - Neonatology

KW - Perinatology

KW - Prenatal care

KW - Preventive medicine

KW - Transfusion medicine

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U2 - 10.5694/mja2.50266

DO - 10.5694/mja2.50266

M3 - Article

JO - Medical Journal Australia

JF - Medical Journal Australia

SN - 0025-729X

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