Safety and immunogenicity of tetanus diphtheria and acellular pertussis (Tdap) immunization during pregnancy in mothers and infants: a randomized clinical trial. Kinetics of the antibody response to tetanus-diphtheria-acellular pertussis vaccine in women of childbearing age and postpartum women. Effectiveness of prenatal tetanus toxoid immunization against neonatal tetanus in a rural area in India. Seroprevalence of tetanus antibodies among pregnant women in Duhok Governorate, Iraq. Maternal vaccination and preterm birth: using data mining as a screening tool Antibody response of pregnant women to two different absorbed tetanus toxoids. Use of tetanus toxoid for the prevention of neonatal tetanus. 1. Reduction of neonatal mortality by immunization of non-pregnant and pregnant women in rural Bangladesh. A cluster randomized non-inferiority field trial on the immunogenicity and safety of tetanus toxoid vaccine kept in controlled temperature chain compared to cold chain. Duration of protective immunity conferred by maternal tetanus toxoid immunization: further evidence from Matlab, Bangladesh. The effect of maternal tetanus immunization on children's schooling attainment in Matlab, Bangladesh: follow-up of a randomized trial. A Randomized Controlled Trial of Oral Administration of Tetanus Toxoid (TT) Versus Tetanus and Reduced Diphtheria (Td) in Pregnant Women Causes of low tetanus toxoid vaccination coverage in pregnant women in Lahore district, Pakistan. The use of toxoid for the prevention of tetanus neonatorum. Final report of a double-blind controlled field trial. Single-dose antenatal tetanus immunisation. Maternal immunization with Haemophilus influenzae type b polysaccharide-tetanus protein conjugate vaccine in The Gambia. The effect of timing of maternal tetanus, diphtheria, and acellular pertussis (Tdap) immunization during pregnancy on newborn pertussis antibody levels - a prospective study. Tetanus, diphtheria, acellular pertussis vaccine during pregnancy: pregnancy and infant health outcomes.
IMPORTANCE Maternal immunization with tetanus toxoid , reduced diphtheria toxoid , and acellular pertussis ( Tdap ) vaccine could prevent infant pertussis . OBJECTIVE To evaluate the safety and immunogenicity of Tdap immunization during pregnancy and its effect on infant responses to diphtheria and tetanus toxoids and acellular pertussis ( DTaP ) vaccine . DESIGN , SETTING , AND PARTICIPANTS Phase 1 - 2 , r and omized , double-blind , placebo-controlled , clinical trial conducted from 2008 to 2012 . Forty-eight pregnant women aged 18 to 45 years received Tdap  ( n = 33 ) or placebo ( n = 15 ) at 30 to 32 weeks ' gestation , with crossover immunization postpartum . INTERVENTIONS Tdap vaccination at 30 to 32 weeks ' gestation or postpartum . MAIN OUTCOMES AND MEASURES Primary outcomes were maternal and infant adverse events , pertussis illness , and infant growth and development until age 13 months . Secondary outcomes were antibody concentrations in  pregnant women before and 4 weeks after Tdap immunization or placebo , at delivery and 2 months ' postpartum , and in infants at birth , at 2 months , and after the third and fourth doses of DTaP. RESULTS No Tdap-associated serious adverse events occurred in women or infants . Injection site reactions after Tdap immunization were reported in 26 ( 78.8 % [ 95 % CI , 61.1%-91.0 % ] ) and 12 ( 80 % [ 95 % CI , 51.9%-95.7 % ] ) pregnant and postpartum women , respectively ( P > .99 ) . Systemic symptoms were reported in 12 ( 36.4 % [ 95 % CI , 20.4%-54.9 % ] ) and 11 ( 73.3 % [ 95 % CI , 44.9%-92.2 % ] ) pregnant and postpartum women , respectively ( P = .03 ) . Growth and development were similar in both infant groups . No cases of pertussis occurred . Significantly higher concentrations of pertussis antibodies were measured at delivery in women who received Tdap during pregnancy vs postpartum ( eg , pertussis toxin antibodies : 51.0 EU/mL [ 95 % CI , 37.1 - 70.1 ] and 9.1 EU/mL [ 95 % CI , 4.6 - 17.8 ] , respectively ; P < .001 ) and in their infants at birth ( 68.8 EU/mL [ 95 % CI , 52.1 - 90.8 ] and 14.0 EU/mL [ 95 % CI , 7.3 - 26.9 ] , respectively ; P < .001 ) and at age 2 months ( 20.6 EU/mL [ 95 % CI , 14.4 - 29.6 ] and 5.3 EU/mL [ 95 % CI , 3.0 - 9.4 ] , respectively ; P < .001 ) . Antibody responses in infants born to women receiving Tdap during pregnancy were not different following the fourth dose of DTaP. CONCLUSIONS AND RELEVANCE This preliminary assessment did not find an increased risk of adverse events among women who received Tdap vaccine during pregnancy or their infants . For secondary outcomes , maternal immunization with Tdap result ed in high concentrations of pertussis antibodies in infants during the first 2 months of life and did not substantially alter infant responses to DTaP. Further research is needed to provide definitive evidence of the safety and efficacy of Tdap immunization during pregnancy . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00707148 BACKGROUND Because adolescents and adults act as a primary source of pertussis infection for infants , vaccination of mothers immediately postpartum is a potential strategy to reduce transmission ( cocoon strategy ) . For this to be effective , high levels of antibodies must be achieved rapidly after vaccination . We sought to determine whether the antibody response to tetanus-diphtheria-acellular pertussis vaccine ( Tdap ) is sufficiently rapid to support the cocoon strategy . METHODS Two sequential studies were performed . The first was a nonr and omized , open study of a 5-pertussis-component Tdap vaccine ( tetanus toxoid , diphtheria toxoid , pertussis toxoid [ PT ] , filamentous hemagglutinin [ FHA ] , fimbriae types 2 and 3 [ FIM ] , and pertactin [ PRN ] ) given to women of childbearing age ; the second was a r and omized , open study of Tdap or no vaccine in postpartum women .  Serum levels of immunoglobin ( Ig ) G and IgA against pertussis antigens , serum levels of IgG against diphtheria and tetanus , and breast milk levels of IgA against pertussis antigens were measured at various times after vaccination . RESULTS In both studies , the antibody response was relatively rapid , with serum IgG and IgA levels beginning to increase noticeably by days 5 - 7 and approaching peak levels by day 14 . Greater than 68 % and 84.4 % of IgG and IgA responders , respectively , achieved ≥ 90 % of their maximum titer by day 14 . The diphtheria and tetanus antibody kinetics followed a similar time course . Breast milk levels of IgA against PT , FHA , and FIM were first detectable at day 7 , peaked by day 10 , and then slowly decreased through day 28 . Antibodies against PRN showed a similar response , although the peak occurred at day 14 . There were no significant antibody responses in the control group . CONCLUSIONS Although the antibody response to a dose of Tdap in healthy nonpregnant women of child-bearing age and postpartum women occurs by day 14 and is suggestive of an anamnestic immune response , it may not be sufficiently rapid to protect infants in the first weeks of life BACKGROUND Neonatal tetanus is the cause of 23 to 73 % of neonatal deaths in developing countries and continues to be an important killer in many parts of India . METHODS In this nonr and omized cohort study in a rural area in India ,  tetanus toxoid immunization status was recorded for 1688 pregnant women . Liveborn children were followed up for 30 days for the occurrence of neonatal tetanus . Nonimmunized and partially immunized women were asked their reasons for not receiving tetanus toxoid vaccine . RESULTS Complete prenatal immunization with tetanus toxoid during pregnancy ( two doses 1 month apart ) was associated with an 88 % reduction in the risk of neonatal tetanus among the newborn children [ 95 % confidence interval ( CI ) 59 to 98 % ] . In multivariable analysis only complete immunization and the use of clean instruments for cutting the umbilical cord were independently associated with a reduction in risk of neonatal tetanus . Registration by the health care provider before 29 weeks of gestation , being 5 km or less from the vaccination facility , having two or more contacts with the health provider and having some school education were independently associated with complete immunization . CONCLUSIONS Immunization of pregnant women with tetanus toxoid was the single most effective intervention against neonatal tetanus independent of other interventions Maternal immunization with tetanus toxoid ( TT ) is the most effective was to prevent neonatal tetanus . In Duhok , Iraq data indicate low vaccination coverage . This study assessed  TT immunization  status among 600 r and omly selected pregnant women attending Azadi teaching hospital , Duhok for delivery , by both tetanus antibody seroprevalence and TT history . WHO criteria for protective levels were used for seroprevalence and vaccination history . Overall , 90 % of the women at delivery had protective tetanus antitoxin titres compared to only 55 % considered protected according to their vaccination history . Immunity rates for women who had received no TT vaccination , 1 dose , 2 doses and > or = 3 doses were 28.0 % , 92.6 % , 100.0 % and 99.0 % respectively . Groups with lower serological immunity levels were women aged less than 25 years , those reporting no history of vaccination and those living in Akre , Bardarash or Shekhan districts of Duhok .  Tetanus immunity determined by seroprevalence of tetanus antitoxin levels exceeded that estimated by vaccination history , and serological markers should be used instead of vaccination history in determining immunity status Objective The main purpose of this study was to identify possible associations between medicines used in pregnancy and preterm deliveries  using data mining as a screening tool . Setting s Prospect i ve cohort study . Methods We used data mining to identify possible correlates between preterm delivery and medicines used by 92,235 pregnant Danish women who took part in the Danish National Birth Cohort ( DNBC ) . We then evaluated the association between one of the identified exposures ( vaccination ) and the risk for preterm birth by using logistic regression . The women were classified into groups according to their exposure to vaccination . The regression analyses were adjusted for the following covariates : parity , infant ’s gender , maternal Body-Mass Index ( BMI ) , age , smoking , drinking , job , number of inhabitants in the place of residence , infections , diabetes , high blood pressure and preeclampsia . Main outcome measurePreterm birth , a delivery occurring before the 259th day of gestation ( i.e. , less than 37 full weeks ) . Results Data mining had indicated that maternal vaccination ( among other factors ) might be related to preterm birth . The following regression analysis showed that , the women who reported being vaccinated shortly before or during gestation had a slightly higher risk of giving preterm birth ( O.R. = 1.14 ; 95 % CI 1.04–1.25 ) as compared to the non-vaccinated group . Conclusion Whether the association between maternal vaccination and the risk for preterm birth found here is causal or not deserves further studies . Data mining , especially with additional refinements , may be a valuable and very efficient tool to screen large data bases for relevant information which can be used in clinical and public health research The antibody response in pregnant women vaccinated with either of two different adsorbed tetanus toxoids  has been studied . One vaccine ( A ) , prepared by toxoiding purified tetanus toxin followed by its adsorption onto calcium phosphate , exhibited a low titre expressed as international immunizing units , 69 IIU/0.5 ml . The other vaccine ( B ) , prepared by purifying formalinized crude tetanus toxin and adsorbing it onto aluminium phosphate showed a high titre , 212 IIU/0.5 ml . No significant differences between titres of circulating antibodies were obtained after the first injection of either vaccine , but titres after the second injection were much higher for vaccine A as compared with those obtained using vaccine B. The results showed that the  immune response in human beings is not correlated to titres expressed in IIU . These results confirm that other methods should be adopted for evaluating the potency of vaccines . A simplified technique based on the comparison of circulating antitoxin levels after vaccination of mice has recently been proposed 1 approach to the prevention of tetanus neonatorum ( a leading cause of infant death throughout the world ) is improving the quality of prenatal , obstetric , and postnatal maternal and child health services . Another complementary approach is the active immunization of women before or during pregnancy with tetanus toxoid .  Work in progress at the Matlab field station of the International Center for Diarrheal Disease Research in Bangladesh ( ICDDR , B ) provided a unique opportunity to study the effectiveness of certain aspects of these 2 strategies . In 1974 , during a field trial of cholera toxoid vaccine , 2 injections of an aluminum phosphate tetanus-diphtheria toxoid were provided as a control to a r and omly assigned group of nonpregnant women . Beginning in June 1978 , a program of immunizing women during pregnancy with aluminum phosphate-absorbed tetanus toxoid was initiated in conjunction with the implementation of a village based maternal and child health and family planning program in half of the same Matlab surveillance area . Throughout the period of these 2 programs , the ICDDR , B maintained an independent , longitudinal , vital registration system , identifying all births and deaths in the study area . In this analysis , all live births registered in the Maternal and Child Health-Family Planning and comparison areas during the September 1 , 1978 until December 31 , 1979 period were identified . These records were linked with any deaths recorded within 28 days of birth . The acceptance of tetanus vaccination  during the 1974 cholera vaccine trial , by the mothers of these live births , was ascertained from the 1974 vaccine registers . The acceptance of vaccination during the 1978 - 1979 program was obtained from the field registers . For infants whose mothers had received 2 tetanus injections 48 - 64 months prior to delivery , the neonatal mortality rate was 63.8/l000 live births compared with 78.3/1000 for infants whose mothers did not receive tetanus immunization . Immunization of women with 2 tetanus injections during pregnancy reduced neonatal mortality rates to 42.8/1000 , a reduction of 35.5/1000 . Mortality on days 4 - 14 was reduced by about 70 % . 1 injection during pregnancy did not appear to provide protection against tetanus neonatorum BACKGROUND In re source -poor setting s , cold chain requirements present barriers for vaccine delivery . We evaluated the immunogenicity and safety of tetanus toxoid ( TT ) vaccine in " Controlled Temperature Chain " ( CTC ; up to 40 ° C for < 30 days before administration ) , compared to st and ard cold chain ( SCC ; 2 - 8 ° C ) . Prior to the study , stability parameters of TT-CTC were shown to meet international requirements . METHODS A cluster r and omized , non-inferiority trial was conducted in Moïssala district , Chad , December 2012-March 2013 . Thirty-four included clusters were r and omized to CTC or SCC . Women aged 14 - 49 years , eligible for TT vaccination and with a history of ≤1 TT dose , received two TT doses 4 weeks apart . Participants were blinded to allocation strategy . Tetanus antibody titers were measured using st and ard ELISA at inclusion and 4 weeks post-TT2 . Primary outcome measures were post-vaccination seroconversion and fold-increase in geometric mean concentrations ( GMC ) . Non-inferiority was by seroconversion difference ( TTSCC-TTCTC ) < 5 % and ratio of GMCs ( TTSCC/TTCTC ) < 1.5 . Adverse events were monitored at health centers and at next contact with participants . RESULTS A total of 2128 women ( CTC=1068 ; SCC=1060 ) were recruited . Primary intention to vaccinate analysis included 1830 participants ; 272 of these were included in the seroconversion analysis . Seroconversion was reached by > 95 % of participants ; upper 95%CI of the difference was 5.6 % . Increases in GMC were over 4-fold ; upper 95%CI of GMC ratio was 1.36 in the adjusted analysis . Few adverse events were recorded . CONCLUSIONS This study demonstrates the immunogenicity and safety of TT in CTC at < 40 ° C for < 30 days . The high proportion of participants protected at baseline results in a reduction of power to detect a 5 % non-inferiority margin . However , results at a 10 % non-inferiority margin , the comparable GMC increases and vaccine 's stability demonstrated in the preliminary phase indicate that CTC can be an alternative strategy for TT delivery in situations where cold chain can not be maintained OBJECTIVES Although maternal tetanus immunization has been shown to be highly effective in the prevention of neonatal tetanus , unresolved questions remain concerning the required minimum number of doses and the result ing duration of effective immunity . This study examined the duration of effective immunity against neonatal tetanus provided by maternal tetanus immunization . METHODS A r and omized , double-blind cholera vaccine trial of 41,571 children and nonpregnant adult women carried out in 1974 in the Matlab comparison area of rural Bangladesh provided a unique opportunity to address dose and immunity issues . RESULTS Children of women who received either 1 or 2 injections of tetanus toxoid experienced 4- to 14-day mortality levels consistently lower than those of children of unimmunized mothers . Analysis of neonatal-tetanus-related mortality showed that 2 injections of tetanus toxoid provided significant protection for subsequent duration s of up to 12 or 13 years . CONCLUSIONS The data demonstrate that a limited-dose regimen of maternal tetanus toxoid provides significant and extended protection against the risk of neonatal tetanus death We investigate the effects of antenatal maternal vaccination against tetanus  on the schooling attained by children in Bangladesh . Maternal vaccination prevents the child from acquiring tetanus at birth through blood infection and substantially reduces infant mortality and may prevent impairment in children who would otherwise acquire tetanus but survive . We follow up on a 1974 r and omized trial of  maternal tetanus vaccination  , looking at outcomes for children born in the period 1975 - 1979 . We find significant schooling gains from maternal tetanus vaccination for children whose parents had no schooling , showing a large impact on a small number of children . Our findings make a case for investments in maternal tetanus vaccination as a method of improving schooling and eventual economic outcomes Introduction The present study was design ed as a r and omized clinical trial to compare the immunogenicity , reactogenicity , and efficacy of tetanus toxoid ( TT ) and the combined tetanus and reduced diphtheria ( Td ) in pregnant women in four rural communities in Egypt . The pregnant women in each four villages received either TT or Td r and omly . Both TT and Td vaccines are manufactured by the Egyptian Company for Biological Products & Vaccines ( VACSERA ) in Egypt . A total of 131 pregnant women were enrolled during the time of antenatal care visit ( at 20 weeks gestational age of pregnancy ) in one of four health units in Abu Homos district , Beheira Governorate , Egypt . Discussion Unimmunized women received two r and om doses of either TT or Td 8 weeks apart during their pregnancy . Outpatient follow-up for adverse reactions occurred at the third day after each vaccine dose as either local effects such as pain , redness , and swelling or systematic effects such as fever , malaise , and headache or body aches which was served as primary safety endpoint . Blood was collected three times from each woman for determination of antibody titer against tetanus and diphtheria by using enzyme-linked immunosorbent assay technique . The first sample was collected immediately before the first dose , the second before the second dose , and the third sample 1 week after delivery . Active surveillance home visits to all study participants were done twice : the first home visit during the first week after delivery and the second 1 month after labor to report the health status of the mother and the baby . A total of 122 pregnant women received two ordinary doses with interdose intervals within the allowable range and three blood sample s were collected in each protocol analysis ( 62 in the TT group and 60 in the Td group ) . There was no statistically significant difference between groups in the percentage of reporting a primary safety endpoint ( fever , malaise , body ache , headache ) or local reactions at the site of injection as redness and swelling , at third day after each dose . While in the Td group , after doses I and II , there was significant reporting pain at injection site as compared with TT group , home visits clinical examination revealed that the mothers and children were normal on in both groups . However , in the TT group , some children suffered from physiological jaundice . In all women in the two groups , protective immunity for tetanus was acquired , which reflected in neutralization of antibodies at titer ( > 0.10 IU/ml ) after complete vaccination ; however , the tetanus geometric mean titers postdoses I and II were significantly higher in TT vaccines group ( P < 0.001 ) . The postvaccination seroprotection titer ( > 0.10 IU/ml ) in diphtheria was significantly higher in Td group than the TT group ; diphtheria geometric mean titers of postdose II were significantly higher in Td vaccines as compared to the other group ( P < 0.0001 ) . From this results , we can conclude that the use of Td vaccine improves immunogenicity for both tetanus and diphtheria more than the use of TT vaccine alone and we can recommend to replace TT in immunization of pregnant women To assess the causes of low tetanus toxoid ( TT ) vaccination coverage in pregnant women a mixture of quantitative and qualitative methods were adopted at the community , primary health care delivery and management levels in Lahore district , Pakistan . Out of a r and om sample of 362 women who had delivered during the previous 3 months , 87 % recalled receiving 2 doses of TT . The main reasons for non-vaccination were poor knowledge about the importance of TT ( 32 % of women ) or the place and time to get vaccinated ( 18 % ) . According to the managers and primary health care medical officers , the main reasons for low coverage were lack of awareness about the importance of vaccination among the public and misconceptions about TT vaccination ( e.g. that it was a contraceptive ) With a view to determining the effectiveness of a method for the control of tetanus neonatorum which would be independent of medical examination or care , a double-blind field trial covering 1618 women was conducted between 1961 and 1966 in a rural area of Colombia with an estimated existing tetanus neonatorum death rate of 11.6 per 100 births . The study group was given 1 - 3 injections of 1 ml of an aluminium-phosphate-adsorbed tetanus toxoid more than 6 weeks apart , and the control group a similar number of injections of an influenza-virus vaccine . There was no statistically significant difference between those in the two groups given one injection . Those in the control group given 2 or 3 injections had a tetanus neonatorum death rate of 7.8 deaths per 100 births , and the corresponding subjects in the study group had none . This difference is unlikely to have occurred by chance Abstract A series of two-dose and one-dose antenatal tetanus immunisation schedules using various toxoids and adjuvants have been examined for their efficacy in producing levels of antitoxin protective against neonatal tetanus at the time of delivery . If a maternal antitoxin titre of 0·01 unit per ml . or more at delivery is accepted as protective , then complete protection was afforded by two doses of a 50 limit-flocculation units ( Lf ) adsorbed toxoid . St and ard doses of commercially available tetanus vaccines do not give complete protection unless three doses are given . The best single-dose schedule tested was 100 Lf of an adsorbed toxoid containing the quaternary ammonium adjuvant ' Arquad 2HT ' ( the principal component of which is dioctadecyl dimethyl ammonium chloride ) , which achieved 83 % protection . There were no adverse reactions of significance reported in any of the schedules . Transfer of antitoxin to the infant is more effective and rapid after a two-dose schedule than after a single dose . Further investigations into immunisation early in pregnancy with adsorbed toxoids in higher doses than used in this investigation ( i.e. , greater than 100 Lf ) are required . From these promising results it is probable that an acceptable one-dose schedule in the prevention of neonatal tetanus will be achieved . Antenatal immunisation effective in protecting against neonatal tetanus does not seem to interfere with subsequent active immunisation in infancy OBJECTIVE To evaluate maternal responses to Haemophilus influenzae type b ( Hib ) polysaccharide-tetanus protein conjugate ( polyribosylribitol phosphate-tetanus or PRP-T ) given to pregnant Gambian women , the transplacental transfer of antibody , and the effect of maternal immunization on infant responses to the vaccine . DESIGN An open , r and omized immunogenicity study . SETTING A busy urban health center in The Gambia . STUDY PARTICIPANTS A total of 451 pregnant women enrolled during the third trimester of pregnancy . INTERVENTION Study participants were r and omized to three groups . In one group , mothers were given PRP-T during the third trimester and their infants were given PRP-T at 2 , 3 , and 4 months of age . In the second group , mothers received PRP-T and infants were given inactivated poliovirus vaccine . In the third group , mothers received meningococcal A and C vaccine , and their infants received PRP-T. MAIN OUTCOME MEASURES Anti-PRP antibody measurements of maternal cord , and infant blood . RESULTS Vaccinated women had a marked increase in total anti-PRP antibody ( geometric mean titer 9.0 micrograms/mL ) , which was greatest in women in their first or second pregnancy . Previous tetanus vaccination during the same pregnancy and high concentrations of antitetanus antibody were associated with lower anti-PRP responses . In infants of PRP-T recipients , cord blood anti-PRP IgG concentrations were 61 % of simultaneous maternal concentrations . In vaccinated infants of vaccinated mothers , geometric mean anti-PRP antibody concentrations at birth , 2 months of age , and 5 months of age were 1.92 , 0.35 and 2.84 micrograms/mL , respectively , while in vaccinated infants of unvaccinated mothers , the corresponding concentrations were 0.29 , 0.12 , and 3.91 micrograms/mL. At 2 months of age , 60 % of infants of vaccinated mothers and 26 % of infants of unvaccinated mothers had anti-PRP antibody concentrations considered to be protective ( > 0.15 micrograms/mL ) . CONCLUSIONS In areas where much invasive Hib disease occurs in infants younger than 6 months , maternal immunization may help to reduce the risk of Hib disease in infants too young for immunization BACKGROUND The Centers for Disease Control and Prevention recommend Tdap immunization during pregnancy , preferably at 27 - 36 weeks . AIM To ascertain whether there is a preferential period of maternal Tdap immunization during pregnancy that provides the highest concentration of pertussis-specific antibodies to the newborn . METHODS This prospect i ve study measured pertussis-specific antibodies in paired maternal-cord sera of women immunized with Tdap after the 20th week of their pregnancy ( n=61 ) . RESULTS The geometric mean concentrations ( GMCs ) of Immunoglobulin G ( IgG ) to pertussis toxin ( PT ) were higher in the newborns ' cord sera when women were immunized at 27 - 30(+6 ) weeks ( n=21 ) compared with 31 - 36 weeks ( n=30 ) and > 36 weeks ( n=7 ) , 46.04 international units/milliliter ( IU/mL ) ( 95 % CI , 24.29 - 87.30 ) vs. 8.69IU/mL ( 95 % CI , 3.66 - 20.63 ) and 21.12IU/mL ( 95 % CI , 7.93 - 56.22 ) , p<0.02 , respectively . The umbilical cord GMCs of IgG to filamentous hemagglutinin ( FHA ) were higher in the newborns ' cord sera when women were immunized at 27 - 30(+6 ) weeks compared with 31 - 36 weeks and > 36 weeks , 225.86IU/mL ( 95 % CI , 182.34 - 279.76 ) vs. 178.31IU/mL ( 95 % CI , 134.59 - 237.03 ) and 138.03IU/mL ( 95 % CI , 97.61 - 195.16 ) , p<0.02 , respectively . CONCLUSIONS Immunization of pregnant women with Tdap between 27 - 30(+6 ) weeks was associated with the highest umbilical cord GMCs of IgG to PT and FHA compared with immunization beyond 31 weeks gestation . Further research should be conducted to reaffirm these finding in order to promote an optimal pertussis controlling policy OBJECTIVE To assess pregnancy and birth outcomes in infants born to women who did or did not receive tetanus , diphtheria , acellular pertussis ( Tdap ) vaccine during pregnancy . STUDY DESIGN Retrospective cohort . Pregnant women 12 - 45 years of age who received Tdap at Intermountain Healthcare facilities and their infants were identified and compared with mother-infant pairs without documented Tdap from May 2005 through August 2009 . Primary measures included pregnancy outcomes and infant health outcomes at birth through 12 months . RESULTS From 162,448 pregnancies we identified 138 women ( 0.08 % ) with documented Tdap administration during pregnancy ( cases ) ; 552 pregnant women without documented Tdap were r and omly selected as controls . Of 138 immunized women , 63 % received Tdap in the first trimester and 37 % after . Tdap was given most commonly as wound prophylaxis . The incidence of spontaneous or elective abortion was no greater in Tdap cases than in controls . There were no significant differences in preterm delivery , gestational age , or birth weight between groups . One or more congenital anomaly was identified in 3.7 % ( 95 % CI 1.2%-8.5 % ) of case infants and 4.4 % ( 95 % CI 2.7%-6.5 % ) of control infants ( P = .749 ) . In infants born to women receiving Tdap during pregnancy , 3.6 % ( 0.8%-10.2 % ) had International Classification of Diseases , Ninth Revision , Clinical Modification diagnoses consistent with complex chronic conditions within 12 months compared with 10.4 % ( 95 % CI 7.2%-14.4 % ) of infants of controls ( P = .054 ) . CONCLUSIONS Documented Tdap administration during pregnancy was uncommon and occurred most often in the first trimester as prophylaxis following trauma . No increase in adverse outcomes was identified in infants born to women receiving Tdap compared with infants of controls
BACKGROUND Tetanus is an acute , often fatal , disease caused by an exotoxin produced by Clostridium tetani .
It occurs in newborn infants born to mothers who do not have sufficient circulating antibodies to protect the infant passively , by transplacental transfer .
Prevention may be possible by the vaccination of pregnant or non-pregnant women , or both , with tetanus toxoid , and the provision of clean delivery services .
Tetanus toxoid consists of a formaldehyde-treated toxin that stimulates the production of antitoxin .
OBJECTIVES To assess the effectiveness of tetanus toxoid , administered to women of reproductive age or pregnant women , to prevent cases of , and deaths from , neonatal tetanus .