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KCE reports vol. 6A Prenatale zorg 119
Study Ref Population Intervention Outcomes Results Comments Study
type
EL
Nair et 4 20 pregnant women HBIG (n = 12) or HBsAg carrier state in 1/20 infants became HBsAg
RCT 1b
al., [391] attending antenatal placebo
infants
and HBeAg positive from
1984
clinic found positive for (n = 8) within 24 hours
the HBIG group
HBsAg and anti-HBe in after birth and at five
USA from 1978 through week intervals for a
1982
total of 6 injections for
infants
Wong et 4 315 pregnant women Group 1: HBV vaccine HBsAg carrier state in HBV carrier rate:
By September 1983, 216 babies RCT 1b
al., 1984 [387] found positive for HBeAg at birth and at 1, 2 and infants
Group 1: 2.9% had been born to 262 mothers
attending antenatal clinic 6 months after birth,
Group 2: 6.8%
in Hong Kong from June plus 7 monthly HBIg
Group 3: 21.0% Infants excluded because of
1981 to September 1983 injections (n = 36)
Group 4: 73.2% low birth weight, low Apgar
from which 262 gave
score, congenital abnormality,
consent
Group 2: same as
(Rates as calculated by life- withdrawn from study,
above, but only one
HBIG injection at birth
table attack-rate analysis) stillbirth, or other criteria
(n = 35)
These results are for 140
babies who were at least 6
Group 3: vaccine only
months of age by September
at 0, 1, 2, and 6
months (n = 35)
1983
Zhu et
al., 1997
4
[388]
204 HBsAg positive
pregnant women from
two hospital obstetric
departments in Shanghai,
China from February 1991
to February 1994
207 babies were born to
Group 4: placebos for
both vaccine and HBIg
(n = 34)
HBIG given 3, 2 and 1
month before delivery
(n = 1 05) vs. no
treatment (n = 102)
Seroconversion to
HBeAg in mothers at 3
months before delivery
Prevention of
intrauterine
transmission of HBV
Treatment group: 37/103
(36%)
Control group: 32/101
(32%)
6/105 HBsAg positive babies
in treatment group (5.7%)
Method of randomisation not
indicated
No losses to follow up
RCT 1b