OBJECTIVES: To evaluate the efficacy and safety of DDAVP in preventing and treating acute bleeding in pregnant women with bleeding disorders.
SEARCH METHODS: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Coaguopathies Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant and abstract books of conferences proceedings. We also searched several clinical trial registries and grey literature (27 August 2017).Date of most recent search of the Cochrane Cystic Fibrosis and Genetic Disorders Group's Coaguopathies Trials Register: 01 October 2018.
SELECTION CRITERIA: Randomised and quasi-randomised controlled trials investigating the efficacy of DDAVP versus tranexamic acid or factor VIII or rFactor VII or fresh frozen plasma in preventing and treating congenital bleeding disorders during pregnancy were eligible.
DATA COLLECTION AND ANALYSIS: No trials matching the selection criteria were eligible for inclusion.
MAIN RESULTS: No trials matching the selection criteria were eligible for inclusion.
AUTHORS' CONCLUSIONS: No randomised controlled trials were identified investigating the relative effectiveness of DDAVP for bleeding during pregnancy in women with congenital bleeding disorders. In the absence of high-quality evidence, clinicians need to use their clinical judgement and lower level evidence (e.g. from observational trials) to decide whether or not to treat women with congenital bleeding disorders with DDAVP.Given the ethical considerations, future randomised controlled trials are unlikely. However, other high-quality controlled studies (such as risk allocation designs, sequential design, parallel cohort design) to investigate the risks and benefits of using DDAVP in this population are needed.Given that there are unlikely to be any trials published in this area, this review will no longer be regularly updated.
OBJECTIVES: To assess the effects of administering anti-D immunoglobulin (Ig) after spontaneous miscarriage in a Rh-negative woman, with no anti-D antibodies.
SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 December 2012).
SELECTION CRITERIA: Randomised controlled trials (RCT) in Rh-negative women without antibodies who were given anti-D Ig following spontaneous miscarriage compared with no treatment or placebo treatment following spontaneous miscarriage as control.
DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and trial quality. Two review authors extracted data and checked it for accuracy.
MAIN RESULTS: We included one RCT, involving 48 women who had a miscarriage between eight to 24 weeks of gestation. Of the 19 women in the treatment group, 14 had therapeutic dilatation & curettage (D&C) and five had spontaneous miscarriage; of the 29 women in the control group, 25 had therapeutic D&C and four had spontaneous miscarriage. The treatment group received 300 µg anti-D Ig intramuscular injection and were compared with a control group who received 1 cc homogenous gamma globulin placebo.This review's primary outcomes (development of a positive Kleihauer Betke test (a test that detects fetal cells in the maternal blood; and development of RhD alloimmunisation in a subsequent pregnancy) were not reported in the included study.Similarly, none of the review's secondary outcomes were reported in the included study: the need for increased surveillance for suspected fetal blood sampling and fetal transfusions in subsequent pregnancies, neonatal morbidity such as neonatal anaemia, jaundice, bilirubin encephalopathy, erythroblastosis, prematurity, hypoglycaemia (low blood sugar) in subsequent pregnancies, maternal adverse events of anti-D administration including anaphylactic reaction and blood-borne infections.The included study did report subsequent Rh-positive pregnancies in three women in the treatment group and six women in the control group. However, due to the small sample size, the study failed to show any difference in maternal sensitisation or development of Rh alloimmunisation in the subsequent pregnancies.
AUTHORS' CONCLUSIONS: There are insufficient data available to evaluate the practice of anti-D administration in an unsensitised Rh-negative mother after spontaneous miscarriage. Thus, until high-quality evidence becomes available, the practice of anti-D Immunoglobulin prophylaxis after spontaneous miscarriage for preventing Rh alloimmunisation cannot be generalised and should be based on the standard practice guidelines of each country.
METHODS: Full and partial economic evaluations, published in English, associated with the management of neonatal systemic infections in South Asia will be included. Any intervention related to management of neonatal systemic infections will be eligible for inclusion. Comparison can include a placebo or alternative standard of care. Interventions without any comparators will also be eligible for inclusion. Outcomes of this review will include measures related to resource use, costs and cost-effectiveness. Electronic searches will be conducted on PubMed, CINAHL, MEDLINE (Ovid), EMBASE, Web of Science, EconLit, the Centre for Reviews and Dissemination Library (CRD) Database, Popline, IndMed, MedKnow, IMSEAR, the Cost Effectiveness Analysis (CEA) Registry and Pediatric Economic Database Evaluation (PEDE). Conference proceedings and grey literature will be searched in addition to performing back referencing of bibliographies of included studies. Two authors will independently screen studies (in title, abstract and full-text stages), extract data and assess risk of bias. A narrative summary and tables will be used to summarize the characteristics and results of included studies.
DISCUSSION: Neonatal systemic infections can have significant economic repercussions on the families, health care providers and, cumulatively, the nation. Pediatric economic evaluations have focused on the under-five age group, and published consolidated economic evidence for neonates is missing in the developing world context. To the best of our knowledge, this is the first review of economic evidence on neonatal systemic infections in the South Asian context. Further, this protocol provides an underst anding of the methods used to design and evaluate economic evidence for methodological quality, transparency and focus on health equity. This review will also highlight existing gaps in research and identify scope for further research.
SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42017047275.