Hydrogel dressings for donor sites of split-thickness skin grafts.

BACKGROUND: Donor site wounds of split-thickness skin grafts can be a major cause of morbidity. Choosing the appropriate dressing for these wounds is crucial to successful healing. Various types of dressing are available, including hydrogel dressings. A review of current evidence is required to guide clinical decision-making on the choice of dressing for the treatment of donor sites of split-thickness skin grafts. OBJECTIVES: To assess the effects of hydrogel dressings on donor site wounds following split-thickness skin grafts for wound healing. SEARCH METHODS: In July 2022 we searched the Cochrane Wounds Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL EBSCO Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses, and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication, or study setting. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing hydrogel dressings with other types of dressing, topical treatments or no dressing, or with different types of hydrogel dressings in managing donor site wounds irrespective of language and publication status. DATA COLLECTION AND ANALYSIS: Two review authors independently carried out data extraction, risk of bias assessment using the Cochrane risk of bias tool, RoB 1, and quality assessment according to GRADE methodology. MAIN RESULTS: We included two studies (162 participants) in this review. One study with three arms and 101 participants (15 months' duration) was conducted in a children's hospital, and compared hydrogel dressings in the form of Sorbact with Algisite, an alginate dressing and Cuticerin, a smooth acetate gauze impregnated with water-repellent ointment. Another study with two arms and 61 participants (19 months' duration) was conducted in three surgery departments and compared an octenidine-containing hydrogel dressing with an identical non-antimicrobial hydrogel dressing. We identified no studies that compared hydrogel dressings with another therapy such as a topical agent (a topical agent is a cream, an ointment or a solution that is applied directly to the wound), or no dressing, or a combination of hydrogel dressings and another therapy versus another therapy alone. Both studies were at high risk of attrition bias and the second study was also at unclear risk of selection bias. Amorphous hydrogel dressings versus other types of dressings Amorphous hydrogel dressings may increase time to wound healing when compared with alginate (mean difference (MD) 1.67 days, 95% confidence interval (CI) 0.56 to 2.78; 1 study, 69 participants; low-certainty evidence) or Cuticerin dressings (MD 1.67 days, 95% CI 0.55 to 2.79; 1 study, 68 participants; low-certainty evidence). The effect of amorphous hydrogel dressings compared with other types of dressings is uncertain for pain at the donor site and wound complications, including scarring and itching (very low-certainty evidence). No adverse events were reported in any of the groups. The study did not report health-related quality of life or wound infection. Octenidine-based hydrogel dressing versus octenidine-free hydrogel dressing The effect of octenidine-based hydrogel dressings versus octenidine-free hydrogel dressings is uncertain for time to wound healing (MD 0.40, 95% CI 0.28 to 0.52; 1 study, 41 participants) and wound infection, as the certainty of the evidence is very low. The certainty of the evidence is also very low for adverse events, with two participants in the intervention group and one participant in the comparison group reporting adverse events (risk ratio (RR) 0.58, 95% CI 0.06 to 5.89; 1 study, 41 participants). The study did not report donor site pain, health-related quality of life, or wound complications. AUTHORS' CONCLUSIONS: There is insufficient evidence to determine the effect of hydrogel dressings on donor site wounds of split thickness skin grafts compared with other types of dressings. There is a need for adequately powered and well-designed RCTs, with adequate sample sizes, types of populations and subgroups, types of interventions, and outcomes, that compare hydrogel dressings with other treatment options in the treatment of donor site wounds of split-thickness skin grafts.

Transcatheter aortic valve implantation versus surgical aortic valve replacement for severe aortic stenosis in people with low surgical risk.

BACKGROUND: Severe aortic valve stenosis (AS) is a major cause of morbidity and mortality worldwide. The definitive management for severe AS is aortic valve replacement (AVR). The choice of transcatheter approach versus open-heart surgery for AVR in people with severe AS and low surgical risk remains a matter of debate. OBJECTIVES: To assess the benefits and harms of transcatheter aortic valve implantation (TAVI) compared to surgical aortic valve replacement (SAVR) in people with severe AS and low surgical risk. SEARCH METHODS: We searched the following databases for randomised controlled trials (RCTs) on 29 April 2019: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and Web of Science Core Collection. We also searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform. We searched all databases from inception to present and imposed no restriction on language or date of publication. SELECTION CRITERIA: We included RCTs that compared TAVI and SAVR in adults (18 years of age or older) with severe AS and low surgical risk. DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures expected by Cochrane. Two authors independently screened titles and abstracts for inclusion, performed data extraction, and assessed risk of bias in the studies included. We analysed dichotomous data using the risk ratio (RR) and continuous data using the mean difference (MD), with respective 95% confidence intervals (CI). We assessed the certainty of evidence for each outcome using the GRADE approach. Our outcomes of interest were assessed in the short term (i.e. during hospitalisation and up to 30 days of follow-up). Primary outcomes were all-cause mortality, stroke, and rehospitalisation. Secondary outcomes were myocardial infarction (MI), cardiac death, length of hospital stay (LOS), permanent pacemaker (PPM) implantation, new-onset atrial fibrillation, acute kidney injury (AKI), and any bleeding. MAIN RESULTS: We identified four studies (13 reports), with 2818 participants, and one ongoing study. Overall certainty of evidence ranged from high to very low. There is probably little or no difference between TAVI and SAVR for the following short-term outcomes: all-cause mortality (RR 0.69, 95% CI 0.33 to 1.44; SAVR 11 deaths per 1000, TAVI 8 deaths per 1000 (95% CI 4 to 16); 2818 participants; 4 studies; moderate-certainty evidence); stroke (RR 0.73, 95% CI 0.42 to 1.25; SAVR 21 strokes per 1000, TAVI 16 strokes per 1000 (95% CI 9 to 27); 2818 participants; 4 studies; moderate-certainty evidence); MI (RR 0.82, 95% CI 0.42 to 1.58; SAVR 14 MI per 1000, TAVI 11 MI per 1000 (95% CI 6 to 21); 2748 participants; 3 studies; moderate-certainty evidence); and cardiac death (RR 0.71, 95% CI 0.32 to 1.56; SAVR 10 cardiac deaths per 1000, TAVI 7 cardiac deaths per 1000 (95% CI 3 to 16); 2818 participants; 4 studies; moderate-certainty evidence). TAVI may reduce the risk of short-term rehospitalisation, although the confidence interval also includes the possibility of no difference in risk between groups (RR 0.64, 95% CI 0.39 to 1.06; SAVR 30 cases per 1000, TAVI 19 cases per 1000 (95% CI 12 to 32); 2468 participants; 2 studies; low-certainty evidence). TAVI, compared with SAVR, probably increases the risk of PPM implantation (RR 3.65, 95% CI 1.50 to 8.87; SAVR 47 per 1000, TAVI 170 cases per 1000 (95% CI 70 to 413); number needed to treat for an additional harmful outcome (NNTH) = 7; 2683 participants; 3 studies; moderate-certainty evidence). We are uncertain whether TAVI, compared with SAVR, affects the LOS in days, although it appears to be associated with shorter LOS. TAVI, compared with SAVR, reduces the risk of atrial fibrillation (RR 0.21, 95% CI 0.15 to 0.30; 2683 participants; 3 studies), AKI (RR 0.30, 95% CI 0.16 to 0.58; 2753 participants; 4 studies), and bleeding (RR 0.31, 95% CI 0.16 to 0.62; 2753 participants; 4 studies) (all high-certainty evidence). AUTHORS' CONCLUSIONS: Our meta-analysis indicates that, in the short term, TAVI probably has little or no mortality difference compared to SAVR for severe AS in individuals with low surgical risk. Similarly, there is probably little or no difference in risk of stroke, MI, and cardiac death between the two approaches. TAVI may reduce the risk of rehospitalisation, but we are uncertain about the effects on LOS. TAVI reduces the risk of atrial fibrillation, AKI, and bleeding. However, this benefit is offset by the increased risk of PPM implantation. Long-term follow-up data are needed to further assess and validate these outcomes, especially durability, in the low surgical risk population.

Transradial versus transfemoral approach for diagnostic coronary angiography and percutaneous coronary intervention in people with coronary artery disease.

BACKGROUND: Cardiovascular disease (CVD) is the major cause of mortality worldwide. Coronary artery disease (CAD) contributes to half of mortalities caused by CVD. The mainstay of management of CAD is medical therapy and revascularisation. Revascularisation can be achieved via coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI). Peripheral arteries, such as the femoral or radial artery, provide the access to the coronary arteries to perform diagnostic or therapeutic (or both) procedures. OBJECTIVES: To assess the benefits and harms of the transradial compared to the transfemoral approach in people with CAD undergoing diagnostic coronary angiography (CA) or PCI (or both). SEARCH METHODS: We searched the following databases for randomised controlled trials on 10 October 2017: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and Web of Science Core Collection. We also searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform in August 2017. There were no language restrictions. Reference lists were also checked and we contacted authors of included studies for further information. SELECTION CRITERIA: We included randomised controlled trials that compared transradial and transfemoral approaches in adults (18 years of age or older) undergoing diagnostic CA or PCI (or both) for CAD. DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures expected by Cochrane. At least two authors independently screened trials, extracted data, and assessed the risk of bias in the included studies. We contacted trial authors for missing information. We used risk ratio (RR) for dichotomous outcomes and mean difference (MD) or standardised mean difference (SMD) for continuous data, with their 95% confidence intervals (CIs). All analyses were checked by another author. MAIN RESULTS: We identified 31 studies (44 reports) including 27,071 participants and two ongoing studies. The risk of bias in the studies was low or unclear for several domains. Compared to the transfemoral approach, the transradial approach reduced short-term net adverse clinical events (NACE) (i.e. assessed during hospitalisation and up to 30 days of follow-up) (RR 0.76, 95% CI 0.61 to 0.94; 17,133 participants; 4 studies; moderate quality evidence), cardiac death (RR 0.69, 95% CI 0.54 to 0.88; 11,170 participants; 11 studies; moderate quality evidence). However, short-term myocardial infarction was similar between both groups (RR 0.91, 95% CI 0.81 to 1.02; 19,430 participants; 11 studies; high quality evidence). The transradial approach had a lower procedural success rate (RR 0.97, 95% CI 0.96 to 0.98; 25,920 participants; 28 studies; moderate quality evidence), but was associated with a lower risk of all-cause mortality (RR 0.77, 95% CI 0.62 to 0.95; 18,955 participants; 10 studies; high quality evidence), bleeding (RR 0.54, 95% CI 0.40 to 0.74; 23,043 participants; 20 studies; low quality evidence), and access site complications (RR 0.36, 95% CI 0.22 to 0.59; 16,112 participants; 24 studies; low quality evidence). AUTHORS' CONCLUSIONS: Transradial approach for diagnostic CA or PCI (or both) in CAD may reduce short-term NACE, cardiac death, all-cause mortality, bleeding, and access site complications. There is insufficient evidence regarding the long-term clinical outcomes (i.e. beyond 30 days of follow-up).

Routes of administration of antibiotic prophylaxis for preventing infection after caesarean section.

BACKGROUND: Post-caesarean section infection is a cause of maternal morbidity and mortality. Administration of antibiotic prophylaxis is recommended for preventing infection after caesarean delivery. The route of administration of antibiotic prophylaxis should be effective, safe and convenient. Currently, there is a lack of synthesised evidence regarding the benefits and harms of different routes of antibiotic prophylaxis for preventing infection after caesarean section. OBJECTIVES: The aim of this review was to assess the benefits and harms of different routes of prophylactic antibiotics given for preventing infectious morbidity in women undergoing caesarean section. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 January 2016), ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (6 January 2016) and reference lists of retrieved studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing at least two alternative routes of antibiotic prophylaxis for caesarean section (both elective and emergency). Cross-over trials and quasi-RCTs were not eligible for inclusion. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion, assessed the risk of bias and extracted data from the included studies. These steps were checked by a third review author. MAIN RESULTS: We included 10 studies (1354 women). The risk of bias was unclear or high in most of the included studies.All of the included trials involved women undergoing caesarean section whether elective or non-elective. Intravenous antibiotics versus antibiotic irrigation (nine studies, 1274 women) Nine studies (1274 women) compared the administration of intravenous antibiotics with antibiotic irrigation. There were no clear differences between groups in terms of this review's maternal primary outcomes: endometritis (risk ratio (RR) 0.95, 95% confidence interval (CI) 0.70 to 1.29; eight studies (966 women) (low-quality evidence)); wound infection (RR 0.49, 95% CI 0.17 to 1.43; seven studies (859 women) (very low-quality evidence)). The outcome of infant sepsis was not reported in the included studies.In terms of this review's maternal secondary outcomes, there were no clear differences between intravenous antibiotic or irrigation antibiotic groups in terms of postpartum febrile morbidity (RR 0.87, 95% CI 0.48 to 1.60; three studies (264 women) (very low-quality evidence)); or urinary tract infection (RR 0.74, 95% CI 0.25 to 2.15; five studies (660 women) (very low-quality evidence)). In terms of adverse effects of the treatment on the women, no drug allergic reactions were reported in three studies (284 women) (very low-quality evidence), and there were no cases of serious infectious complications reported (very low-quality evidence). There was no clear difference between groups in terms of maternal length of hospital stay (mean difference (MD) 0.28 days, 95% CI -0.22 to 0.79 days, (random-effects analysis), four studies (512 women). No data were reported for the number of women readmitted to hospital. For the baby, there were no data reported in relation to oral thrush, infant length of hospital stay or immediate adverse effects of the antibiotics on the infant. Intravenous antibiotic prophylaxis versus oral antibiotic prophylaxis (one study, 80 women) One study (80 women) compared an intravenous versus an oral route of administration of prophylactic antibiotics, but did not report any of this review's primary or secondary outcomes. AUTHORS' CONCLUSIONS: There was no clear difference between irrigation and intravenous antibiotic prophylaxis in reducing the risk of post-caesarean endometritis. For other outcomes, there is insufficient evidence regarding which route of administration of prophylactic antibiotics is most effective at preventing post-caesarean infections. The quality of evidence was very low to low, mainly due to limitations in study design and imprecision. Furthermore, most of the included studies were underpowered (small sample sizes with few events). Therefore, we advise caution in the interpretation and generalisability of the results.For future research, there is a need for well-designed, properly-conducted, and clearly-reported RCTs. Such studies should evaluate the more recently available antibiotics, elaborating on the various available routes of administration, and exploring potential neonatal side effects of such interventions.

Interventions for acne scars.

BACKGROUND: Acne scarring is a frequent complication of acne and resulting scars may negatively impact on an affected person's psychosocial and physical well-being. Although a wide range of interventions have been proposed, there is a lack of high-quality evidence on treatments for acne scars to better inform patients and their healthcare providers about the most effective and safe methods of managing this condition. This review aimed to examine treatments for atrophic and hypertrophic acne scars, but we have concentrated on facial atrophic scarring. OBJECTIVES: To assess the effects of interventions for treating acne scars. SEARCH METHODS: We searched the following databases up to November 2015: the Cochrane Skin Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library (2015, Issue 10), MEDLINE (from 1946), EMBASE (from 1974), and LILACS (from 1982). We also searched five trials registers, and checked the reference lists of included studies and relevant reviews for further references to randomised controlled trials. SELECTION CRITERIA: We include randomised controlled trials (RCTs) which allocated participants (whether split-face or parallel arms) to any active intervention (or a combination) for treating acne scars. We excluded studies dealing only or mostly with keloid scars. DATA COLLECTION AND ANALYSIS: Three review authors independently extracted data from each of the studies included in this review and evaluated the risks of bias. We resolved disagreements by discussion and arbitration supported by a method expert as required. Our primary outcomes were participant-reported scar improvement and any adverse effects serious enough to cause participants to withdraw from the study. MAIN RESULTS: We included 24 trials with 789 adult participants aged 18 years or older. Twenty trials enrolled men and women, three trials enrolled only women and one trial enrolled only men. We judged eight studies to be at low risk of bias for both sequence generation and allocation concealment. With regard to blinding we judged 17 studies to be at high risk of performance bias, because the participants and dermatologists were not blinded to the treatments administered or received; however, we judged all 24 trials to be at a low risk of detection bias for outcome assessment. We evaluated 14 comparisons of seven interventions and four combinations of interventions. Nine studies provided no usable data on our outcomes and did not contribute further to this review's results.For our outcome 'Participant-reported scar improvement' in one study fractional laser was more effective in producing scar improvement than non-fractional non-ablative laser at week 24 (risk ratio (RR) 4.00, 95% confidence interval (CI) 1.25 to 12.84; n = 64; very low-quality evidence); fractional laser showed comparable scar improvement to fractional radiofrequency in one study at week eight (RR 0.78, 95% CI 0.36 to 1.68; n = 40; very low-quality evidence) and was comparable to combined chemical peeling with skin needling in a different study at week 48 (RR 1.00, 95% CI 0.60 to 1.67; n = 26; very low-quality evidence). In a further study chemical peeling showed comparable scar improvement to combined chemical peeling with skin needling at week 32 (RR 1.24, 95% CI 0.87 to 1.75; n = 20; very low-quality evidence). Chemical peeling in one study showed comparable scar improvement to skin needling at week four (RR 1.13, 95% CI 0.69 to 1.83; n = 27; very low-quality evidence). In another study, injectable fillers provided better scar improvement compared to placebo at week 24 (RR 1.84, 95% CI 1.31 to 2.59; n = 147 moderate-quality evidence).For our outcome 'Serious adverse effects' in one study chemical peeling was not tolerable in 7/43 (16%) participants (RR 5.45, 95% CI 0.33 to 90.14; n = 58; very low-quality evidence).For our secondary outcome 'Participant-reported short-term adverse events', all participants reported pain in the following studies: in one study comparing fractional laser to non-fractional non-ablative laser (RR 1.00, 95% CI 0.94 to 1.06; n = 64; very low-quality evidence); in another study comparing fractional laser to combined peeling plus needling (RR 1.00, 95% CI 0.86 to 1.16; n = 25; very low-quality evidence); in a study comparing chemical peeling plus needling to chemical peeling (RR 1.00, 95% CI 0.83 to 1.20; n = 20; very low-quality evidence); in a study comparing chemical peeling to skin needling (RR 1.00, 95% CI 0.87 to 1.15; n = 27; very low-quality evidence); and also in a study comparing injectable filler and placebo (RR 1.03, 95% CI 0.10 to 11.10; n = 147; low-quality evidence).For our outcome 'Investigator-assessed short-term adverse events', fractional laser (6/32) was associated with a reduced risk of hyperpigmentation than non-fractional non-ablative laser (10/32) in one study (RR 0.60, 95% CI 0.25 to 1.45; n = 64; very low-quality evidence); chemical peeling was associated with increased risk of hyperpigmentation (6/12) compared to skin needling (0/15) in one study (RR 16.00, 95% CI 0.99 to 258.36; n = 27; low-quality evidence). There was no difference in the reported adverse events with injectable filler (17/97) compared to placebo (13/50) (RR 0.67, 95% CI 0.36 to 1.27; n = 147; low-quality evidence). AUTHORS' CONCLUSIONS: There is a lack of high-quality evidence about the effects of different interventions for treating acne scars because of poor methodology, underpowered studies, lack of standardised improvement assessments, and different baseline variables.There is moderate-quality evidence that injectable filler might be effective for treating atrophic acne scars; however, no studies have assessed long-term effects, the longest follow-up being 48 weeks in one study only. Other studies included active comparators, but in the absence of studies that establish efficacy compared to placebo or sham interventions, it is possible that finding no evidence of difference between two active treatments could mean that neither approach works. The results of this review do not provide support for the first-line use of any intervention in the treatment of acne scars.Although our aim was to identify important gaps for further primary research, it might be that placebo and or sham trials are needed to establish whether any of the active treatments produce meaningful patient benefits over the long term.

High feedback versus low feedback of prenatal ultrasound for reducing maternal anxiety and improving maternal health behaviour in pregnancy.

BACKGROUND: Prenatal ultrasound is one of many techniques used in screening and diagnosis. It gives parents instant access to the images of the fetus. Receiving information promotes knowledge and understanding, but it may also increase maternal anxiety. OBJECTIVES: To compare high feedback versus low feedback during prenatal ultrasound for reducing maternal anxiety and improving maternal health behaviour. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (12 May 2015), the Central Register of Controlled Trials (The Cochrane Library 2015, Issue 5), MEDLINE (January 1966 to 12 May 2015), and the ISRCTN Registry (12 May 2015). We handsearched citation lists of relevant publications. We did not apply any language or date restrictions. SELECTION CRITERIA: Randomised controlled trials (RCTs) of high feedback (women can see the monitor screen and receive detailed visual and verbal explanations) versus low feedback (women can not see the monitor screen and women are given only a summary statement of the scan) during prenatal ultrasound. The primary outcome measure was maternal state anxiety. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked for accuracy. We have expressed results as risk ratio (RR) or mean differences (MD), together with their 95% confidence intervals (CI). MAIN RESULTS: We included four studies (365 women). Three RCTs (346 participants) reported the effect of high versus low feedback during ultrasound on state anxiety scores (mean difference (MD) 0.92, 95% confidence interval (CI) -0.58 to 2.43; participants = 346; three studies, low quality evidence). Two trials (148 participants) reported women's views of the level of feedback. They do not show that women in the high feedback groups are more likely to choose very positive adjectives to describe their feelings after the scan (risk ratio (RR) 3.30; 95% CI 0.73 to 14.85). Women who had a high feedback during ultrasound were more likely to stop smoking during pregnancy (RR 2.93, 95% CI 1.25 to 6.86; participants = 129; one study; low quality evidence) and to avoid alcohol during pregnancy (RR 2.96, 95% CI 1.15 to 7.60; participants = 129; one study; low quality evidence). Downgrading of evidence was based on the unclear risk of bias of included studies, wide CI crossing the line of no effect or presence of heterogeneity. AUTHORS' CONCLUSIONS: There is insufficient evidence to support either high or low feedback during a prenatal ultrasound to reduce maternal anxiety and promote health behaviour.

Hydralazine and nitrates alone or combined for the management of chronic heart failure: A systematic review.

BACKGROUND: Hydralazine (H) and nitrates (Ns), when combined, reduced morbidity and mortality in some trials of chronic heart failure (CHF). It is unclear whether either agent used alone provides similar benefits. We aimed to evaluate the effects of H and/or N in patients with CHF. METHODS: A systematic review of randomised trials assessing the effects of H and N in CHF. For meta-analysis, only the endpoints of all-cause mortality and cardiovascular mortality were considered. RESULTS: In seven trials evaluating H&N in 2626 patients, combination therapy reduced all-cause mortality (OR 0.72; 95% CI 0.55-0.95; p=0.02), and cardiovascular mortality (OR 0.75; 95% CI 0.57-0.99; p=0.04) compared to placebo. However, when compared to angiotensin converting enzyme inhibitors (ACEIs), combination therapy was associated with higher all-cause mortality (OR 1.35; 95% CI 1.03-1.76; p=0.03), and cardiovascular mortality (OR 1.37; 95% CI 1.04-1.81; p=0.03). For N alone, ten trials including 375 patients reported all-cause mortality and showed a trend to harm (13 deaths in those assigned to nitrates and 7 to placebo; OR 2.13; 95% CI 0.88-5.13; p=0.09). For H alone, three trials showed no difference in all-cause mortality compared to placebo (OR 0.96; 95% CI 0.37-2.47; p=0.93), and two trials suggested inferiority to ACEI (OR 2.28; 95% CI 1.03-5.04; p=0.04). CONCLUSIONS: Compared to placebo, H&N reduces mortality in patients with CHF. Whether race or background therapy influences benefit is uncertain, but on direct comparison H&N appears inferior to ACEI. There is little evidence to support the use of either drug alone in CHF.

Antibiotic prophylaxis in prelabor spontaneous rupture of fetal membranes at or beyond 36 weeks of pregnancy.

OBJECTIVE: To assess the effectiveness of prophylactic antibiotics compared with placebo in preventing neonatal and maternal infection-related morbidity associated with prelabor spontaneous rupture of membranes at or beyond 36 weeks of pregnancy. METHODS: In the present randomized controlled trial conducted during 2009-2011, 1640 women with prelabor spontaneous rupture of fetal membranes at or beyond 36 weeks of pregnancy were randomly assigned to receive a single dose of prophylactic intravenous antibiotics or placebo on admission to the labor ward of Ain Shams University, Cairo, Egypt. The participants, caregivers, and investigators were blinded to the group assignment. The primary outcome measure was early-onset neonatal sepsis. An intention-to-treat analysis was performed. RESULTS: Early-onset neonatal sepsis occurred in 34 (4.1%) and 24 (2.9%) neonates in the antibiotics and placebo groups, respectively (risk ratio 1.42; 95% confidence interval 0.85-2.37). Maternal infection outcomes were not significantly different between the 2 trial arms. CONCLUSION: The routine use of prophylactic antibiotics in women with prelabor spontaneous rupture of fetal membranes at or beyond 36 weeks of pregnancy does not reduce the risk of neonatal and maternal infection-related morbidity.

Tight control of mild-moderate pre-existing or non-proteinuric gestational hypertension.

BACKGROUND: The question of the target blood pressure in pregnant women with mild-moderate hypertension continues to be an area of debate. OBJECTIVES: To compare tight versus very tight control of mild-moderate pre-existing or non-proteinuric gestational hypertension for improving outcomes SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 March 2011), CENTRAL (The Cochrane Library 2011, Issue 3), MEDLINE (January 1966 to March 2011), and the metaRegister of Controlled Trials (31 March 2011). We handsearched citation lists of relevant publications, review articles, and included studies. SELECTION CRITERIA: Randomized controlled trials of tight versus very tight control in pregnant women with mild or moderate pre-existing or non-proteinuric gestational hypertension. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial quality and extracted data. We expressed results as risk ratio (RR) or mean differences, together with their 95% confidence intervals (CI). MAIN RESULTS: We included two studies (256 participants) with mild-moderate pre-existing or non-proteinuric gestational hypertension. There was no evidence of a difference between tight and very tight control groups regarding severe pre-eclampsia (risk ratio (RR) 1.28, 95% CI 0.97 to 1.70; two trials, 256 participants). More women in the tight group were hospitalized during their pregnancy (RR 2.53, 95% CI 1.14 to 5.63; one trial, 125 participants). There was no evidence of a difference in other outcome measures including fetal distress, IUGR, neonatal admission to a NICU, perinatal deaths, induction of labor and cesarean delivery between the tight and the very tight control groups. Gestational age at delivery had a non-significant mean difference (MD) of -0.15 weeks between the tight and very tight control groups (MD -0.15, 95% CI -1.52 to 1.21, random-effects, T² = 0.75, I² = 77%; two trials, 256 participants). The MD in birthweight between the tight and the very tight control group was not significant (MD -100.00 grams, 95% CI -363.69 to 163.69; one trial, 125 participants). AUTHORS' CONCLUSIONS: For pregnant women with non-severe pre-existing or non-proteinuric gestational hypertension, there is insufficient evidence to determine how tight control of hypertension should be achieved to improve maternal and fetal-neonatal outcomes.

High feedback versus low feedback of prenatal ultrasound for reducing maternal anxiety and improving maternal health behaviour in pregnancy.

BACKGROUND: Prenatal ultrasound is one of many techniques used in screening and diagnosis. It gives parents instant access to the images of the fetus. Receiving information promotes knowledge and understanding, but it may also increase maternal anxiety. OBJECTIVES: To compare high feedback versus low feedback during prenatal ultrasound for reducing maternal anxiety and improving maternal health behaviour. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (March 2010), the Central Register of Controlled Trials (The Cochrane Library 2010, Issue 1), MEDLINE (January 1966 to 1 March 2010), and the metaRegister of Controlled Trials (mRCT) (March 2010). We handsearched citation lists of relevant publications. We did not apply any language restrictions. SELECTION CRITERIA: Randomized controlled trials (RCTs) of high feedback (women can see the monitor screen and receive detailed visual and verbal explanations) versus low feedback (women can not see the monitor screen and women are given only a summary statement of the scan) during prenatal ultrasound. The primary outcome measure was maternal state anxiety. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial quality and extracted data. We have expressed results as risk ratio (RR) or mean differences, together with their 95% confidence intervals (CI). MAIN RESULTS: We included four studies (365 women). Three RCTs(346 participants) reported the effect of high versus low feedback during ultrasound on state anxiety scores (mean difference 0.92, 95% CI -0.58 to 2.43). Two trials (148 participants) reported women's views of the level of feedback. They do not show that women in the high feedback groups are more likely to choose very positive adjectives to describe their feelings after the scan (RR 3.30; 95% CI 0.73 to 14.85). Women who had a high feedback during ultrasound were more likely to stop smoking during pregnancy (one trial, 129 participants; RR 2.93; 95% CI 1.25 to 6.86) and to avoid alcohol during pregnancy (one trial, 129 participants; RR 2.96; 95% CI 1.15 to 7.60). AUTHORS' CONCLUSIONS: There is insufficient evidence to support either high or low feedback during a prenatal ultrasound to reduce maternal anxiety and promote health behaviour.

Amniotic fluid index versus single deepest vertical pocket: a meta-analysis of randomized controlled trials.

OBJECTIVE: To compare the use of the amniotic fluid index with the single deepest vertical pocket measurement, during antepartum fetal surveillance, in preventing adverse pregnancy outcome. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (January 2008), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2008, Issue 2), MEDLINE (1966 to May 2008), and the metaRegister of Controlled Trials (May 2008). We handsearched the citation lists of relevant publications, review articles, and included studies. SELECTION CRITERIA: Randomized controlled trials involving women with a singleton pregnancy, whether at low or high risk, undergoing ultrasound measurement of amniotic fluid volume as part of antepartum assessment of fetal well-being that compared the amniotic fluid index and the single deepest vertical pocket measurement. DATA COLLECTION AND ANALYSIS: Both authors independently assessed eligibility and quality, and extracted the data. RESULTS: Four trials (3125 women) met the inclusion criteria. When the amniotic fluid index was used, significantly more cases of oligohydramnios were diagnosed (risk ratio (RR) 2.33, 95% CI 1.67-3.24), and more women had inductions of labor (RR 2.10, 95% CI 1.60-2.76) and cesarean delivery for fetal distress (RR 1.45, 95% CI 1.07-1.97). There is no evidence that one method is superior to the other in the prevention of poor peripartum outcomes, including: admission to a neonatal intensive care unit; an umbilical artery pH of less than 7.1; the presence of meconium; an Apgar score of less than 7 at 5 minutes; or cesarean delivery. CONCLUSION: Single deepest vertical pocket measurement is the method of choice for the assessment of amniotic fluid volume.

Isosorbide mononitrate versus alendronate for postmenopausal osteoporosis.

OBJECTIVE: To compare the effectiveness, safety, and affordability of isosorbide mononitrate with alendronate for postmenopausal osteoporosis. METHODS: A randomized controlled trial of 60 postmenopausal women with osteoporosis. Participants were randomly assigned to receive either 20 mg daily of isosorbide mononitrate or 70 mg weekly of alendronate for 12 months. Bone mineral density (BMD) was measured using dual X-ray absorptiometry (DXA) at baseline and after 12 months. RESULTS: Both groups showed significant improvement in BMD. Isosorbide mononitrate yielded a comparable effect to alendronate for BMD and T-score at the end of the follow-up period. For BMD and T score the mean differences between the 2 groups were -0.005 (95% CI, -0.02 to 0.03) and 0.31 (95% CI, -0.03 to 0.64), respectively. A 10.8% and 12.1% change in BMD after 12 months was seen for isosorbide mononitrate and alendronate, respectively. CONCLUSION: Isosorbide mononitrate is comparable to alendronate. Nitric oxide donors may be an effective and affordable therapy to improve bone mineral density.

Amniotic fluid index versus single deepest vertical pocket as a screening test for preventing adverse pregnancy outcome.

BACKGROUND: Amniotic fluid volume is an important parameter in the assessment of fetal well-being. Oligohydramnios occurs in many high-risk conditions and is associated with poor perinatal outcomes. Many caregivers practice planned delivery by induction of labor or caesarean section after diagnosis of decreased amniotic fluid volume at term. There is no clear consensus on the best method to assess amniotic fluid adequacy. OBJECTIVES: To compare the use of the amniotic fluid index with the single deepest vertical pocket measurement as a screening tool for decreased amniotic fluid volume in preventing adverse pregnancy outcome. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (January 2008), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2007, Issue 2), MEDLINE (1966 to May 2007) and the metaRegister of Controlled Trials (May 2007). We handsearched the citation lists of relevant publications, review articles, and included studies. SELECTION CRITERIA: Randomised controlled trials involving women with a singleton pregnancy, whether at low or high risk, undergoing ultrasound measurement of amniotic fluid volume as part of antepartum assessment of fetal well-being that compared the amniotic fluid index and the single deepest vertical pocket measurement. DATA COLLECTION AND ANALYSIS: Both authors independently assessed eligibility and quality, and extracted the data. MAIN RESULTS: Four trials (3125 women) met the inclusion criteria. There is no evidence that one method is superior to the other in the prevention of poor peripartum outcomes, including: admission to a neonatal intensive care unit; an umbilical artery pH of less than 7.1; the presence of meconium; an Apgar score of less than 7 at five minutes; or caesarean delivery. When the amniotic fluid index was used, significantly more cases of oligohydramnios were diagnosed (risk ratio (RR, random) 2.33, 95% CI 1.67 to 3.24), and more women had inductions of labor (RR (fixed) 2.10, 95% CI 1.60 to 2.76) and caesarean delivery for fetal distress (RR (fixed) 1.45, 95% CI 1.07 to 1.97). AUTHORS' CONCLUSIONS: The single deepest vertical pocket measurement in the assessment of amniotic fluid volume during fetal surveillance seems a better choice since the use of the amniotic fluid index increases the rate of diagnosis of oligohydramnios and the rate of induction of labor without improvement in peripartum outcomes. A systematic review of the diagnostic accuracy of both methods in detecting decreased amniotic fluid volume is required.

A randomized trial of tight vs. less tight control of mild essential and gestational hypertension in pregnancy.

OBJECTIVES: To assess the effects of applying a tight vs. a less tight control of mild chronic essential or gestational non-proteinuric hypertension in pregnancy. METHODS: A randomized trial was conducted in 2006-2007 in the University of Ain Shams, Egypt. Eligible participants (n=125) were randomly assigned to either tight or less tight control of mild chronic (essential) or gestational (non-proteinuric) hypertension. The primary outcome measure was the development of severe hypertension during follow-up. Analysis was by intention-to-treat. RESULTS: In the tight target group, adjustment of the dose with an increment of 191 mg yielded a mean dose of methyldopa of 1267+/-406 mg. Both systolic and diastolic BP levels were significantly less than in the tight target group. More women in the less tight group had severe hypertension during follow up (RR 3.167 and 95% CI 1.36-7.37). The rate of antenatal hospitalization was significantly higher in the less tight target group with a relative risk of 2.57 and 95% CI 1.16-5.70. The gestational age at delivery was significantly better in the tight target group. Preterm delivery and birth weight were not significantly different between the study groups. CONCLUSION: Tight control of blood pressure reduces the rate of antenatal hospitalization and does not adversely affect perinatal outcomes in women with mild essential or gestational hypertension.

A randomized clinical trial of the effects of isosorbide mononitrate on bone formation and resorption in post-menopausal women: a pilot study.

BACKGROUND: Nitric oxide (NO) stimulates bone formation and inhibits bone resorption in vitro. NO donors (nitrates) are inexpensive and widely available, but their value for post-menopausal osteoporosis has never been evaluated in a randomized trial. The objective of this study was to compare the effects of 5 and 20 mg of isosorbide mononitrate (ISMO) on markers of bone turnover in post-menopausal women. METHODS: A prospective randomized trial was carried out in the Department of Obstetrics & Gynecology, Ain Shams University, Egypt. The study included 50 healthy post-menopausal women with a hip bone mineral density T score between 0 and -2.5. Participants were randomly assigned to 5 or 20 mg/day of ISMO for 12 weeks. Urine N-telopeptide (NTx), a marker of bone resorption, and serum bone-specific alkaline phosphatase (BSALP), a marker of bone formation, were measured. Markers were measured immediately before randomization and after 12 weeks of treatment. The percent change in NTx and BSALP for each of the treatment groups (5 mg ISMO and 20 mg ISMO) was calculated. The main outcome measures were serum NTx and BSALP in the 5 and 20 mg ISMO groups after 12 weeks of treatment. RESULTS: Women adhering to 20 mg of ISMO had a 42.03% (95% confidence interval (CI), 20.1-73.7) reduction in NTx and a 29.05% (95% CI, 10.8-48.4) increase in BSALP, and women adhering to 5 mg of ISMO had a 31.12% (95% CI, 8.3-68.2) reduction in NTx and a 28.4% (95% CI, 4.6-52.1) increase in BSALP. CONCLUSION: ISMO, as a NO donor, may be useful for the prevention of post-menopausal osteoporosis.