METHODS: Women at term with one transverse lower segment cesarean delivery who were suitable for and who planned VBAC were approached to participate. Participants were randomly assigned to weekly membrane sweeping or weekly vaginal assessment for Bishop score until delivery. Participants and delivery providers were blinded to the allocated treatment. Standard obstetric care was given to all participants. The primary outcome was onset of labor which was defined as the presence of spontaneous regular and painful contractions that cause cervical dilation to at least 3 cm or prelabor rupture of membranes. Secondary outcomes included induction of labor and repeat cesarean delivery.
RESULTS: One hundred eight women were randomly assigned to membrane sweeping and 105 to control. The spontaneous labor rate was 78.5% compared with 72.1% (relative risk [RR] 1.1, 95% confidence interval [CI] 0.9-1.3; P=.34), the induction of labor rate was 12.1% compared with 9.6% (RR 1.3, 95% CI 0.6-2.8; P=.66), and the all-cause cesarean delivery rate was 40.2% compared with 44.2% (RR 0.9, 95% CI 0.7-1.2; P=.58) for the membrane sweeping and control groups, respectively. Gestational age at delivery (mean+/-standard deviation) of 39.6+/-1.0 weeks for the membrane sweeping group compared with 39.6+/-0.9 weeks for the control group (P=.84) was no different.
CONCLUSION: Serial membrane sweeping at term in women who planned VBAC has no significant effect on the onset of labor, pregnancy duration, induction of labor, or repeat cesarean delivery.
CLINICAL TRIAL REGISTRATION: ISRCTN, isrctn.org, ISRCTN55163179.
LEVEL OF EVIDENCE: I.
OBJECTIVES: To assess the effect of increased energy intake on mortality and respiratory, growth and neurodevelopmental outcomes for preterm infants with (or developing) CLD/BPD. Secondarily, the review examines any adverse effects associated with increased energy intake.
SEARCH STRATEGY: The standard search strategy of the Cochrane Neonatal Review Group was used. This included searches of the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 1, 2006) , MEDLINE (accessed via Ovid), references cited in previous relevant Cochrane reviews and in other relevant studies, review articles, standard textbooks, and manuals of neonatal medicine. Hand search results of the Cochrane Neonatal Review Group were also assessed.
SELECTION CRITERIA: All randomized and quasi-randomized trials comparing the outcomes of preterm infants with (or developing) CLD/BPD who had either increased (> 135 kcal/kg/day) or standard energy intake (98 to 135 kcal/kg/day). Increasing energy intake might be achieved enterally and/or parenterally, enterally by increasing the energy content of the milk, increasing feed volume, or by nutrient supplementation with protein, carbohydrate or fat. The primary outcomes were the development of CLD and neonatal mortality; secondary outcomes included respiratory morbidities, growth, neurodevelopmental status and possible complications with increased energy intake.
DATA COLLECTION AND ANALYSIS: We planned to extract data using the standard methods of the Cochrane Neonatal Review Group. Relevant trials would be scrutinized for methodological quality independently by the reviewers to determine their eligibility for inclusion. Data of the included trials would be expressed as relative risk, risk difference, NNT and weighted mean difference where appropriate, using a fixed effect model.
MAIN RESULTS: No eligible trials were identified. Twelve studies that appeared to be relevant were excluded, as no study directly compared increased versus standard energy intakes in infants with CLD/BPD. However, two excluded trials provided some insights into the topic. One study showed that infants with CLD/BPD who were fed formula enriched with protein and minerals had improved growth parameters up until the cessation of the intervention at three months of corrected age. The other study compared different energy density of formula but identical energy intake by setting different feed volumes for both groups. It showed that both groups were unable to achieve the pre-designated feed volumes, and that there were no differences in growth, respiratory outcomes, oedema and the diuretic requirements.
AUTHORS' CONCLUSIONS: To date, no randomized controlled trials are available that examine the effects of increased versus standard energy intake for preterm infants with (or developing) CLD/BPD. Research should be directed at evaluating the effects of various levels of energy intake on this group of infants on clinically important outcomes like mortality, respiratory status, growth and neurodevelopment. The benefits and harms of various ways of increasing energy intake, including higher energy density of milk feed and/or fluid volume (clinically realistic target volume should be set), parenteral nutrition, and the use of various constituents of energy like carbohydrate, protein and fat for this purpose also need to be assessed.