-
Health Technology Assessment... Feb 2009To identify any evidence for advances in the use of routine antenatal anti-D prophylaxis (RAADP) since the 2002 National Institute for Health and Clinical Excellence... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
To identify any evidence for advances in the use of routine antenatal anti-D prophylaxis (RAADP) since the 2002 National Institute for Health and Clinical Excellence (NICE) appraisal, and to assess the current clinical effectiveness and cost-effectiveness of RAADP for Rhesus D (RhD)-negative women.
DATA SOURCES
Main bibliographic databases were searched from inception to July 2007.
REVIEW METHODS
Selected studies were assessed and data extracted using a standard template and quality assessment based on published criteria. Meta-analysis was used where appropriate, otherwise outcomes were tabulated and discussed within a descriptive synthesis. The health economic model developed for the 2002 NICE appraisal of RAADP was modified to assess the cost-effectiveness of different regimens of RAADP.
RESULTS
The clinical effectiveness searches identified 670 potentially relevant articles. Of these, 12 papers were included in the review, relating to eight studies of clinical effectiveness. With one exception, no additional studies were identified in comparison with the previous assessment report, and some of the studies of clinical effectiveness included in the 2002 review had to be excluded because they did not use currently licensed doses. Therefore, eight studies comparing RAADP with no prophylaxis were identified in the clinical effectiveness review and nine (including the 2001 assessment report itself) in the cost-effectiveness review. The clinical efficacy studies were generally of poor quality and did not provide a basis for differentiating between regimens of RAADP. The best indication of the likely efficacy of a programme of RAADP comes from two non-randomised community-based studies. The pooled results of these suggest that such a programme may reduce the sensitisation rate from 0.95% (95% CI 0.18-1.71) to 0.35% (95% CI 0.29-0.40). This gives an odds ratio for the risk of sensitisation of 0.37 (95% CI 0.21-0.65) and an absolute reduction in risk of sensitisation in RhD-negative mothers at risk (i.e. carrying a RhD-positive child) of 0.6%. The identified studies suggest that RAADP has minimal adverse effects. Of the nine studies in the cost-effectiveness review, only two described a model that could be applicable to the NHS. The economic model modified from the 2002 appraisal suggests that the cost per quality-adjusted life-year (QALY) gained of RAADP given to RhD-negative primigravidae versus no treatment is between 9000 pounds and 15,000 pounds, and for RAADP given to all RhD-negative women rather than to RhD-negative primigravidae only is between 20,000 pounds and 35,000 pounds depending upon the regimen. The sensitivity analysis suggests that the results are reasonably robust to changes in the assumptions within the model.
CONCLUSIONS
RAADP reduces the incidence of sensitisation and hence of haemolytic disease of the newborn. The economic model suggests that RAADP given to all RhD-negative pregnant women is likely to be cost-effective at a threshold of around 30,000 pounds per QALY gained. The total cost of providing RAADP to RhD-negative primigravidae in England and Wales is estimated to be around 1.8-3.1 million pounds per year, depending upon regimen, and to all RhD-negative pregnant women in England and Wales around 2-3.5 million pounds.
Topics: Cost-Benefit Analysis; Female; Humans; Immunologic Factors; Infant, Newborn; Isoantibodies; Pregnancy; Pregnancy Complications, Hematologic; Premedication; Prenatal Care; Rh Isoimmunization; Rh-Hr Blood-Group System; Rho(D) Immune Globulin
PubMed: 19210896
DOI: 10.3310/hta13100 -
The Cochrane Database of Systematic... Apr 2007Neonates from isoimmunized pregnancies have increased morbidity from neonatal jaundice. The increased bilirubin from haemolysis often needs phototherapy, exchange... (Review)
Review
BACKGROUND
Neonates from isoimmunized pregnancies have increased morbidity from neonatal jaundice. The increased bilirubin from haemolysis often needs phototherapy, exchange transfusion or both after birth. Various trials in pregnant women who were not isoimmunized but had other risk factors for neonatal jaundice have shown a reduction in need for phototherapy and exchange transfusion by the use of antenatal phenobarbital. A recent retrospective case-controlled study showed reduction in the need for exchange transfusion for the neonates from isoimmunized pregnancies.
OBJECTIVES
To assess the effects of antenatal phenobarbital in red cell isoimmunized pregnancies in reducing the incidence of phototherapy and exchange transfusion for the neonate.
SEARCH STRATEGY
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (June 2006).
SELECTION CRITERIA
Randomised and quasi-randomised controlled trials of pregnant women established to have red cell isoimmunization in the current pregnancy during their antenatal testing and given phenobarbital alone or in combination with other drugs before birth.
DATA COLLECTION AND ANALYSIS
All three review authors independently assessed study eligibility and quality.
MAIN RESULTS
No trials met the inclusion criteria for this review.
AUTHORS' CONCLUSIONS
The use of antenatal phenobarbital to reduce neonatal jaundice in red cell isoimmunized pregnant women has not been evaluated in randomised controlled trials.
Topics: Excitatory Amino Acid Antagonists; Female; Humans; Infant, Newborn; Jaundice, Neonatal; Phenobarbital; Pregnancy; Prenatal Care; Rh Isoimmunization
PubMed: 17443599
DOI: 10.1002/14651858.CD005541.pub2 -
The Cochrane Database of Systematic... Oct 2006Double volume exchange transfusion is commonly used in newborns with severe jaundice in order to prevent kernicterus and other toxicity related to hyperbilirubinemia.... (Review)
Review
BACKGROUND
Double volume exchange transfusion is commonly used in newborns with severe jaundice in order to prevent kernicterus and other toxicity related to hyperbilirubinemia. Most commonly, exchange transfusions are used in infants with rhesus hemolytic disease.
OBJECTIVES
To compare the effectiveness of single volume exchange transfusion (SVET) with that of double volume exchange transfusion (DVET) in producing survival without disability and reducing bilirubin levels in newborn infants with severe jaundice.
SEARCH STRATEGY
MEDLINE, EMBASE (Excerpta Medica online), The Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library), SCISEARCH (Science Citation Index), Reference lists from the articles identified in the search of the databases, and from review articles were searched through March 2006. Personal communication with experts in the field was used to identify unpublished data.
SELECTION CRITERIA
All Randomised and quasi randomised control trials comparing single volume and double volume exchange transfusions in jaundiced newborn infants were included.
DATA COLLECTION AND ANALYSIS
Safety and efficacy of single and double volume exchange compared with regards to long term neurodevelopment, reduction in bilirubin levels and other complications during exchange transfusion. Data was evaluated separately with regards to the cause of jaundice. Relative risk (RR) and weighted mean difference (WMD) were calculated for dichotomous and continuous variables respectively. 95% confidence intervals were used and a fixed effects model was assumed.
MAIN RESULTS
Only one study fulfilled the criteria (Amato 1988). 20 full term babies requiring exchange transfusion for hemolytic jaundice due to ABO incompatibility were randomly allocated to receive single or double volume exchange transfusion. Base line characteristics of both groups were similar with regards to birth weight 3260 (SD 390) g vs. 3350 SD (410) g, gestational age 39 (SD 1) week vs. 40 (SD 0.8) week, immediate pre exchange bilirubin level 199 (SD 33) micromol/L vs. 216 (SD 55) micromol/L. Both groups were treated equally apart from the volume of blood used for exchange transfusion. Total bilirubin levels immediately after exchange transfusion were not significantly different in either group. No long term neurodevelopmental outcome was examined in this study.
AUTHORS' CONCLUSIONS
There was insufficient evidence to support or refute the use of single volume exchange transfusion as opposed to double volume exchange transfusion in jaundiced newborns. A change from the current practice of double volume exchange transfusions for severe jaundice in newborns infant, cannot be recommended on current evidence.
Topics: Bilirubin; Blood Group Incompatibility; Exchange Transfusion, Whole Blood; Humans; Infant, Newborn; Jaundice, Neonatal
PubMed: 17054210
DOI: 10.1002/14651858.CD004592.pub2 -
Progres En Urologie : Journal de... Apr 2006The growth of living donor kidney transplantation, facilitated by revision of the French Bioethics Law of 6 August 2004, is sometimes fJced with the problem of ABO blood... (Review)
Review
The growth of living donor kidney transplantation, facilitated by revision of the French Bioethics Law of 6 August 2004, is sometimes fJced with the problem of ABO blood group incompatibility between the recipient and a potential donor. Are the risks of ABO-incompatible organ transplantation sufficiently mastered to allow satisfactory results? The authors conducted a review of ABO-incompatible transplantations in the light of the current state of knowledge on the immunological mechanisms involved and a systematic review of the international literature to define their level of proof.
Topics: ABO Blood-Group System; Blood Group Incompatibility; Humans; Kidney Transplantation; Postoperative Complications
PubMed: 16734231
DOI: No ID Found -
Ginecologia Y Obstetricia de Mexico May 2005Red cell alloimmunization is an important cause of perinatal morbidlity and mortality. Invasive procedures used to diagnose fetal anemia are associated with serious... (Review)
Review
BACKGROUND
Red cell alloimmunization is an important cause of perinatal morbidlity and mortality. Invasive procedures used to diagnose fetal anemia are associated with serious fetal and maternal complications. The development of noninvasive techniques as Doppler ultrasound can help us in the fetal anemia diagnosis.
OBJECTIVES
To evaluate the effect of the Doppler ultrasound in prediction of fetal anemia caused by red cell alloimmunization. Strategy search: Relevant studies were identified by reviewing the registry of COCHRANE, and OVID, PROQUEST, MEDLINE and EMBASE data bases from 1966 to 2004.
SELECTION CRITERIA
All prospective studies with clinically relevant results with comparison of Doppler ultrasound in fetal umbilical artery, fetal descendent aorta, middle cerebral fetal artery or esplecnic fetal artery with hemoglobin or fetal hematocrit.
DATA COLLECTION AND ANALYSIS
Data were extracted from each report. The quality revision of the studies and the data compilation were made by the reviewers.
MAIN RESULTS
Eighteen articles were included. Two studies reached the level of evidence 1 for diagnostic tests. The diagnostic tests had variations depending on the different cut-off of each study. Studies with level 1 of evidence reported detection of 100% for moderate to severe fetal anemia.
CONCLUSIONS
Implementation of Doppler ultrasound for prediction of fetal anemia in complicated pregnancies with alloimmunization could reduce the number of invasive procedures and therefore its complications. The level of present evidence reveals to us that the studies do not fulfill the criteria of methodological quality.
Topics: Anemia; Aorta; Erythroblastosis, Fetal; Evidence-Based Medicine; Female; Fetal Blood; Histocompatibility, Maternal-Fetal; Humans; Maternal-Fetal Exchange; Middle Cerebral Artery; Predictive Value of Tests; Pregnancy; Prospective Studies; Rh Isoimmunization; Rh-Hr Blood-Group System; Sensitivity and Specificity; Splenic Artery; Ultrasonography, Doppler; Ultrasonography, Prenatal; Umbilical Arteries
PubMed: 21966762
DOI: No ID Found -
Archives of Disease in Childhood. Fetal... Jan 2003To assess the effectiveness of high dose intravenous immunoglobulin (HDIVIG) in reducing the need for exchange transfusion in neonates with proven haemolytic disease due... (Review)
Review
OBJECTIVES
To assess the effectiveness of high dose intravenous immunoglobulin (HDIVIG) in reducing the need for exchange transfusion in neonates with proven haemolytic disease due to Rh and/or ABO incompatibility. To assess the effectiveness of HDIVIG in reducing the duration of phototherapy and hospital stay.
DESIGN
Systematic review of randomised and quasi-randomised controlled trials comparing HDIVIG and phototherapy with phototherapy alone in neonates with Rh and/or ABO incompatibility.
RESULTS
Significantly fewer infants required exchange transfusion in the HDIVIG group (relative risk (RR) 0.28 (95% confidence interval (CI) 0.17 to 0.47); number needed to treat 2.7 (95% CI 2.0 to 3.8)). Also hospital stay and duration of phototherapy were significantly reduced.
CONCLUSION
HDIVIG is an effective treatment.
Topics: Blood Transfusion; Erythroblastosis, Fetal; Humans; Immunoglobulins, Intravenous; Infant, Newborn; Length of Stay; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 12496219
DOI: 10.1136/fn.88.1.f6 -
The Cochrane Database of Systematic... 2002Exchange transfusion and phototherapy have traditionally been used to treat jaundice and avoid the associated neurological complications. Exchange transfusion is not... (Review)
Review
BACKGROUND
Exchange transfusion and phototherapy have traditionally been used to treat jaundice and avoid the associated neurological complications. Exchange transfusion is not without risk and intravenous immunoglobulin has been suggested as an alternative therapy for isoimmune haemolytic jaundice to reduce the need for exchange transfusion.
OBJECTIVES
To assess whether the use of intravenous immunoglobulin, in newborn infants with isoimmune haemolytic jaundice, is effective in reducing the need for exchange transfusion.
SEARCH STRATEGY
The search strategy of the Cochrane Neonatal Review group was used. Searches were made of MEDLINE 1966-2002, EMBASE Drugs and Pharmacology 1990-2002, Cochrane Controlled Trials Register, The Cochrane Library, Issue 1, 2002, expert informants, review articles, cross references, and hand searching of abstracts and conference proceedings of the annual meetings of The Society for Pediatric Research 1990-2001 and The European Society for Paediatric Research 1990-2001.
SELECTION CRITERIA
All randomised and quasi-randomised controlled trials of the use of intravenous immunoglobulin in the treatment of isoimmune haemolytic disease were considered.
DATA COLLECTION AND ANALYSIS
The standard methods of the Cochrane Collaboration and its Neonatal Review Group were used. Studies were assessed for inclusion and quality by two reviewers working independently, with the second reviewer blinded to trial author, institution and journal of publication. Data were extracted independently by the two reviewers. Any differences of opinion were discussed and a consensus reached. Investigators were contacted for additional or missing information. For categorical outcomes, the relative risk (RR), risk difference (RD) and the number needed to treat (NNT) were calculated. For continuous variables, the weighted mean difference (WMD) was calculated.
MAIN RESULTS
Seven studies were identified. Three of these fulfilled the inclusion criteria and included a total of 189 infants. Term and preterm infants and infants with rhesus and ABO incompatibility were included. The use of exchange transfusion decreased significantly in the immunoglobulin treated group (typical RR 0.28, 95% CI 0.17, 0.47; typical RD -0.37, 95% CI -0.49, -0.26; NNT 2.7). The mean number of exchange transfusions per infant was also significantly lower in the immunoglobulin treated group (WMD -0.52, 95% CI -0.70, -0.35). None of the studies assessed long term outcomes.
REVIEWER'S CONCLUSIONS
Although the results show a significant reduction in the need for exchange transfusion in those treated with intravenous immunoglobulin, the applicability of the results is limited. The number of studies and infants included is small and none of the three included studies was of high quality. The protocols of two of the studies mandated the use of early exchange transfusion, limiting the generalizability of the results. Further well designed studies are needed before routine use of intravenous immunoglobulin can be recommended for the treatment of isoimmune haemolytic jaundice.
Topics: Anemia, Hemolytic; Anemia, Neonatal; Humans; Immunoglobulins, Intravenous; Infant, Newborn; Jaundice, Neonatal; Randomized Controlled Trials as Topic
PubMed: 12137687
DOI: 10.1002/14651858.CD003313 -
Obstetrics and Gynecology Sep 2001To estimate, in maternal red blood cell alloimmunization, the diagnostic value of fetal ultrasonography and Doppler blood flow velocity in the evaluation and prediction... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To estimate, in maternal red blood cell alloimmunization, the diagnostic value of fetal ultrasonography and Doppler blood flow velocity in the evaluation and prediction of fetal anemia.
METHODS
Literature from 1970 to 2000 was identified using general bibliographic databases (MEDLINE and EMBASE), the Cochrane Library and relevant specialist register of the Cochrane Collaboration, and by checking reference lists of known primary and review articles. Studies were selected if the accuracy of the fetal ultrasound parameters or Doppler studies of blood flow in the fetal vessels was estimated compared with a reference standard (fetal hemoglobin). The diagnostic tests evaluated were ultrasound measurement of the fetal spleen perimeter and Doppler studies of blood velocity estimates in the umbilical vein, ductus venosus, middle cerebral artery, thoracic aorta, and umbilical vessel combined with the thoracic aorta. Study selection, quality assessment, and data abstraction were performed independently and in duplicate. Data from the selected studies were abstracted as 2 x 2 tables comparing the diagnostic test result with the reference standard. Diagnostic accuracy was expressed as likelihood ratios.
RESULTS
The review included eight primary studies with 362 pregnancies affected by red cell alloimmunization. Prospective patient recruitment and complete population details were reported in half of the selected studies (four of eight). Only one study reported masking the diagnostic test results to clinicians. The diagnostic test performance varied widely according to the type of the test evaluated and the cutoff level used to define fetal anemia, which varied from study to study. The diagnostic test study of highest methodological quality reported a positive likelihood ratio of 8.45 (95% confidence interval 4.69, 15.56) and negative likelihood ratio of 0.02 (95% confidence interval 0.001, 0.25) for maximum middle cerebral artery Doppler velocity.
CONCLUSION
The literature reporting noninvasive techniques to predict fetal anemia is methodologically poor and a standard approach to the evaluation of these techniques is lacking. A recommendation for practice cannot be generated without further rigorous research.
Topics: Blood Flow Velocity; Erythroblastosis, Fetal; Female; Humans; Likelihood Functions; Middle Cerebral Artery; Predictive Value of Tests; Pregnancy; Rh Isoimmunization; Ultrasonography, Doppler; Ultrasonography, Prenatal; Umbilical Veins
PubMed: 11530138
DOI: 10.1016/s0029-7844(01)01425-9 -
Seminars in Gastrointestinal Disease Apr 2001Cholestasis is a common finding after liver transplantation and usually signifies graft dysfunction. The most important factor in the evaluation of patients with... (Review)
Review
Cholestasis is a common finding after liver transplantation and usually signifies graft dysfunction. The most important factor in the evaluation of patients with cholestasis is an awareness of the disorders that commonly arise along a time continuum post-transplant. Therefore, the approach to cholestasis requires a systematic review of biochemical, histological, and radiographic data. This article considers the causes of cholestasis in liver transplant recipients, excluding those associated with biliary anastomotic stricturing. These causes include conditions as diverse as ischemia reperfusion injury, ABO blood group incompatibility, hepatic arterial thrombosis, cytomegalovirus infection, fibrosing cholestatic hepatitis secondary to hepatitis B and C viruses, recurrent primary sclerosing cholangitis, recurrent primary biliary cirrhosis, and chronic rejection. Also examined are management issues pertinent to these conditions and strategies used in preventing or diminishing the effects of cholestasis once established.
Topics: Adult; Cholangitis, Sclerosing; Cholestasis; Diagnosis, Differential; Humans; Liver Transplantation; Male
PubMed: 11352120
DOI: No ID Found -
The Cochrane Database of Systematic... 2000The development of Rh immunisation and its prophylactic use since the 1970s has meant that severe Rhesus D (RhD) alloimmunisation is now rarely seen. (Review)
Review
BACKGROUND
The development of Rh immunisation and its prophylactic use since the 1970s has meant that severe Rhesus D (RhD) alloimmunisation is now rarely seen.
OBJECTIVES
The objective of this systematic review was to assess the effects of giving anti-D to Rhesus negative women, with no anti-D antibodies, who had given birth to a Rhesus positive infant.
SEARCH STRATEGY
We searched the Cochrane Pregnancy and Childbirth Group trials register, the Cochrane Controlled Trials Register, MEDLINE (from 1966 to January 1999) and reference lists of relevant articles. Date of last search of Cochrane Controlled Trials Register: January 1999.
SELECTION CRITERIA
Randomised trials in Rhesus negative women without antibodies who were given anti-D immunoglobulin postpartum compared with no treatment or placebo.
DATA COLLECTION AND ANALYSIS
Assessments of inclusion criteria, trial quality and data extraction were done by each author independently. Initial analyses included all trials. Other analyses assessed the effect of trial quality, ABO compatibility and dose.
MAIN RESULTS
Six eligible trials compared postpartum anti-D prophylaxis with no treatment or placebo. The trials involved over 10,000 women, but trial quality varied. Anti-D lowered the incidence of RhD alloimmunisation six months after birth (relative risk 0.04, 95% confidence interval 0.02 to 0.06), and in a subsequent pregnancy (relative risk 0.12, 95% confidence interval 0. 07 to 0.23). These benefits were seen regardless of the ABO status of the mother and baby and when anti-D was given within 72 hours of birth. Higher doses (up to 200 micro grams) were more effective than lower doses (up to 50 micro grams) in preventing RhD alloimmunisation in a subsequent pregnancy.
REVIEWER'S CONCLUSIONS
Anti-D, given within 72 hours after childbirth, reduces the risk of RhD alloimmunisation in Rhesus negative women who have given birth to a Rhesus positive infant. However the evidence on the optimal dose is limited.
Topics: Female; Humans; Postpartum Period; Rh Isoimmunization; Rho(D) Immune Globulin
PubMed: 10796089
DOI: 10.1002/14651858.CD000021