The effectiveness of Routine Antenatal Anti-D Prophylaxis. v.1.1
Research type
Research Study
Full title
The effectiveness of Routine Antenatal Anti-D Prophylaxis in Haemolytic-Disease-of-the-New-born
IRAS ID
154080
Contact name
Mohamed Elmi
Contact email
Sponsor organisation
Homerton university Hospital
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
1500 IU prophylactic anti-D is routinely administered to Rhesus negative pregnant women at 28 weeks of gestation. The prophylactic anti-D prevents the mother in producing antibodies against their infant especially if the infant’s blood group is Rhesus positive. The manufacturer states that prophylaxis of anti-D protects such mothers from producing antibodies against their infants for up to 12 weeks.
Unlike other blood products, one same dose of 1500 IU prophylactic anti-D is given to all Rh D negative pregnant women who are eligible regardless of their age or weight whereas the transfusion of other blood products are based on patient’s weight and age.
Even though, the introduction of prophylactic anti-D has reduced the incidence of HDFN, still In England and Wales alone, 500 foetuses are affected with HDFN every year, and 25 to 30 babies die from HDN (NICE 2007).
As a result, this research will look into Rh D negative mothers who received 1500 IU prophylactic Anti-D at 28 weeks of gestation with no detectable levels of prophylactic Anti-D at delivery whether their infants are affected by HDFN. This will enable us to learn if no prophylactic anti-D in these women’s plasma means no protection of producing antibodies against their infants and in turn, proof of this may influence changing the current regimen in the guideline
The weight of Rh D negative mothers who received 1500 IU prophylactic Anti-D with no detectable levels of Anti-D at delivery will also be compared to the weight of other Rh D negative mothers with detectable levels of Anti-D at delivery. This is important since other blood products are issued based on patient’s weight due to efficacy, whereas Anti-D is not.The level of protection in Rh D negative mothers who go overdue (above 40 weeks of pregnancy) will also be investigated since the Prophylactic Anti-D covers only up to 12 weeks.
REC name
London - Fulham Research Ethics Committee
REC reference
18/LO/0063
Date of REC Opinion
30 Jan 2018
REC opinion
Unfavourable Opinion