Prevention of Rhesus Immunization. A Controlled Clinical Trial with a Comparatively Low Dose of Anti-D Immunoglobulin

Wit, C. Dudok de; Borst-Eilers, E; Weerdt, Ch. M. van der; Kloosterman, G.J.

doi:10.1136/bmj.4.5629.477

Cited by 13 publications

(7 citation statements)

References 8 publications

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“…Most trials were performed in the 1960’s and 1970’s [ 30 , 33 – 39 ], and several had multiple publications providing data at different time points or from different countries (footnoted in Table 2 ). Six trials evaluated postpartum RhIg [ 30 , 33 – 35 , 38 , 40 ], three trials evaluated antenatal RhIg [ 32 , 41 , 42 ], two trials evaluated RhIg given to women who experienced abortion [ 37 , 39 ], and two trials evaluated antenatal RhIg given either intramuscularly or intravenously [ 43 , 44 ]. All but one trial [ 42 ] reported the women who were sensitized within the first year postpartum or at a subsequent Rh-positive pregnancy, and four studies reported adverse events (AEs) [ 39 , 42 – 44 ].…”

Section: Resultsmentioning

confidence: 99%

“…In RCTs, RoB was moderate and high for sensitization and high for AEs ( Table 4 ). Four studies did not use truly random methods for randomization (e.g., birth date) [ 30 , 34 , 35 , 41 ] and six studies did not provide sufficient information to judge the method of randomization [ 32 , 33 , 38 , 39 , 42 , 43 ]. The method of allocation concealment was not reported in seven of the trials [ 32 , 33 , 38 – 40 , 42 , 44 ].…”

Section: Resultsmentioning

confidence: 99%

“…No RhIg . Five trials compared RhIg (dose ranging from 200 to 6000 μg) given between 24 and 72 hours after delivery (n = 4756) to no RhIg (n = 2843) [ 30 , 33 – 35 , 38 ]. Four of these trials provided information by dose [ 30 , 31 , 34 , 35 ].…”

Section: Resultsmentioning

confidence: 99%

“…Trials were conducted in Argentina, Australia, Canada, France, Germany, the Netherlands, Scotland, the UK, and the USA. Most trials were performed in the 1960's and 1970's [30,[33][34][35][36][37][38][39], and several had multiple publications providing data at different time points or from different countries (footnoted in Table 2). Six trials evaluated postpartum RhIg [30, 33-35, 38, 40], three trials evaluated antenatal RhIg [32,41,42], two trials evaluated RhIg given to women who experienced abortion [37,39], and two trials evaluated antenatal RhIg given either intramuscularly or intravenously [43,44].…”

Section: Study Selection and Characteristicsmentioning

confidence: 99%

“…However, the four trials that reported AEs were not able to blind participants to treatment, and thus a judgement of high risk was assigned. Only one trial reported that the outcomes assessors were blind to treatment group [35], with the remaining trials not providing any information. As no trials reported working from an a priori developed protocol, selective reporting was rated as high, unless AEs were reported.…”

Section: Risk Of Bias Of Included Studiesmentioning

confidence: 99%

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Antenatal and postpartum prevention of Rh alloimmunization: A systematic review and GRADE analysis

et al. 2020

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Background Existing systematic reviews of Rh immunoprophylaxis include only data from randomized controlled trials, have dated searches, and some do not report on all domains of risk of bias or evaluate the certainty of the evidence. Our objective was to perform an updated review, by including new trials, any comparative observational studies, and assessing the certainty of the evidence using the GRADE framework. Methods We searched MEDLINE, Embase and the Cochrane Library from 2000 to November 26, 2019. Relevant websites and bibliographies of systematic reviews and guidelines were searched for studies published before 2000. Outcomes of interest were sensitization and adverse events. Risk of bias was evaluated with the Cochrane tool and ROBINS-I. The certainty of the evidence was performed using the GRADE framework. Results Thirteen randomized trials and eight comparative cohort studies were identified, evaluating 12 comparisons. Although there is some evidence of beneficial treatment effects (e.g., at 6months postpartum, fewer women who received RhIg at delivery compared to no RhIg became sensitized [70 fewer sensitized women per 1,000 (95%CI: 67 to 71 fewer); I 2 = 73%]), due to very low certainty of the evidence, the magnitude of the treatment effect may be overestimated. The certainty of the evidence was very low for most outcomes often due to high risk of bias (e.g., randomization method, allocation concealment, selective reporting) and imprecision (i.e., few events and small sample sizes). There is limited evidence on prophylaxis for invasive fetal procedures (e.g. amniocentesis) in the comparative literature, and few studies reported adverse events.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Study Selection and Characteristicsmentioning

confidence: 99%

Section: Risk Of Bias Of Included Studiesmentioning

confidence: 99%

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Antenatal and postpartum prevention of Rh alloimmunization: A systematic review and GRADE analysis

et al. 2020

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Anti-D administration after childbirth for preventing Rhesus alloimmunisation

Crowther

Middleton

1997

Cochrane Database of Systematic Reviews

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Fetomaternal hemorrhage: incidence, risk factors, time of occurrence, and clinical effects

Sebring

Polesky²

1990

Transfusion

236

201

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Most women have only very small amounts of fetal blood in their circulations following pregnancy and delivery: the volume is less than 0.5 mL of whole blood in 93 percent of women, less than 1 mL in 96 percent, and less than 2 mL in 98 percent. FMH of 30 mL or more occurs in just 3 of 1000 women. When the FMH was 150 mL or more, 15 of 41 infants did not survive Rh-negative women with FMH of more than 30 mL of Rh-positive whole blood are at increased risk of Rh immunization, and thus the outcome of their future pregnancies also may be affected. ABO-compatible fetal red cells that have entered the maternal circulation have a life span similar to that of adult cells. ABO-incompatible fetal red cells may be cleared rapidly, but in some cases they circulate for weeks. Most FMHs of 30 mL or more occur before labor, delivery, or cesarean section. The majority occur with minimal clinical signs and symptoms in apparently normal pregnancies. The identification of postpartum Rh-negative women who have 30 mL or more of Rh-positive fetal blood in their circulation is important so that sufficient RhIG for immune suppression can be administered. It appears that more than one-half of women with FMH of 30 mL or more would not be identified if protocols were adopted to test only women in pregnancies considered to be at high risk.

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Prevention of Rhesus Immunization. A Controlled Clinical Trial with a Comparatively Low Dose of Anti-D Immunoglobulin

Cited by 13 publications

References 8 publications

Antenatal and postpartum prevention of Rh alloimmunization: A systematic review and GRADE analysis

Antenatal and postpartum prevention of Rh alloimmunization: A systematic review and GRADE analysis

Anti-D administration after childbirth for preventing Rhesus alloimmunisation

Fetomaternal hemorrhage: incidence, risk factors, time of occurrence, and clinical effects

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