Dataset Information

Antenatal betamethasone and incidence of neonatal respiratory distress after elective caesarean section: pragmatic randomised trial.

ABSTRACT:

Objective

To test whether steroids reduce respiratory distress in babies born by elective caesarean section at term.

Design

Multicentre pragmatic randomised trial.

Setting

10 maternity units.

Participants

998 consenting women randomised at decision to deliver by elective caesarean section; 503 randomised to treatment group.

Interventions

The treatment group received two intramuscular doses of 12 mg betamethasone in the 48 hours before delivery. The control group received treatment as usual.

Outcome measures

The primary outcome was admission to special care baby unit with respiratory distress. Secondary outcomes were severity of respiratory distress and level of care in response.

Results

Sex, birth weight, and gestation were not different between the two groups. Of the 35 babies admitted to special baby units with respiratory distress, 24 were in the control group and 11 in the intervention group (P = 0.02). The incidence of admission with respiratory distress was 0.051 in the control group and 0.024 in the treatment group (relative risk 0.46, 95% confidence interval 0.23 to 0.93). The incidence of transient tachypnoea of the newborn was 0.040 in the control group and 0.021 in the treatment group (0.54, 0.26 to 1.12). The incidence of respiratory distress syndrome was 0.011 in the control group and 0.002 in the treatment group (0.21, 0.03 to 1.32).

Conclusions

Antenatal betamethasone and delaying delivery until 39 weeks both reduce admissions to special care baby units with respiratory distress after elective caesarean section at term.

SUBMITTER: Stutchfield P

PROVIDER: S-EPMC1226243 | biostudies-literature | 2005 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Antenatal betamethasone and incidence of neonatal respiratory distress after elective caesarean section: pragmatic randomised trial.

Stutchfield Peter P Whitaker Rhiannon R Russell Ian I

BMJ (Clinical research ed.) 20050822 7518

<h4>Objective</h4>To test whether steroids reduce respiratory distress in babies born by elective caesarean section at term.<h4>Design</h4>Multicentre pragmatic randomised trial.<h4>Setting</h4>10 maternity units.<h4>Participants</h4>998 consenting women randomised at decision to deliver by elective caesarean section; 503 randomised to treatment group.<h4>Interventions</h4>The treatment group received two intramuscular doses of 12 mg betamethasone in the 48 hours before delivery. The control gro ...[more]

PMID: 16115831

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Project description:BackgroundWhile foetal distress is typically associated with ischaemic injury, few studies have assessed neonatal morbidity for emergency caesarean section. Moreover, the decision of the anaesthetic technique may be of paramount importance in emergency caesareans, because of the limited time and increased risk. We aimed to evaluate the effect of the anaesthetic technique on neonatal morbidity in emergency caesarean indicated for foetal distress.MethodsThis was a single-centre, prospective observational study, conducted between July-2015 and December-2015. The study enrolled parturient with indication for emergency caesarean section after diagnosis of foetal distress, who received either regional or general anaesthesia. The outcome measures were: 1, 5-minute Apgar scores; umbilical blood pH; length of hospitalization; and morbidity, defined as a 5-minute Apgar score <7, need for mechanical ventilation, admittance to a neonatal intensive care unit, or respiratory insufficiency symptoms.Results61 patients were included in the study, of whom 31 received regional anaesthesia. Neonatal morbidity was noted in 5 and 9 cases with regional and general anaesthesia, respectively. The 1-minute Apgar score was significantly lower(p = 0,045) for cases with general anaesthesia, which was not true for the 5-minute Apgar score. Regional anaesthesia was non-significantly associated with shorter length of hospitalization, lower incidence of morbidity, and higher umbilical blood pH. When we take regional anaesthesia cases as a reference point, we detected that general anaesthesia cases are showing 2,2 times more morbidity risk. But these results did not reach any statistically significant levels.ConclusionsWhile we did find some improved results for regional anaesthesia group, we found no statistical evidence that neither anaesthesia technique is superior regarding neonatal morbidity. We think that regional anaesthesia should be preferred whenever possible because of our improved results of length of hospital stay, APGAR and morbidity and we think that general anaesthesia is indicated for very urgent cases or regional anaesthesia contraindicated patients.Trial registrationhttp://www.isrctn.com/ISRCTN15181117.

Project description:Nausea and vomiting are common complications in patients undergoing caesarean delivery under regional anaesthesia. When experienced after surgery, they may delay recovery, reduce patient satisfaction and affect the bonding between mother and baby. Various pharmacological and non-pharmacological approaches for prophylaxis and treatment of postoperative nausea and vomiting (PONV) have been employed with different degree of efficacy. In this pilot randomised controlled trial, we aimed to determine the possible preventative effects of chewing gum on the rate of PONV in expectant mothers undergoing neuraxial anaesthesia for elective lower segment caesarean section. All participants underwent spinal anaesthesia with administration of 10-11.5 mg of intrathecal heavy Bupivicaine 0.5% according to anaesthetists' preference, Morphine 100 μg and Fentanyl 25 μg. Postoperative analgesia regimen was also standardised. Two hundred ninety-six patients were randomised to an intervention arm to receive chewing gum in addition to standard therapy and to a non-intervention arm to receive standard therapy. After exclusions, 258 patients were followed up 24 h postoperatively. Standard therapy is defined as Ondansetron 4 mg IV intra-operatively. The primary outcomes were the incidences of nausea and vomiting in the first 24 h postoperatively. Secondary outcomes were the number of episodes of nausea or vomiting in the recovery room and on the ward 24 h postoperatively, use of anti-emetics postoperatively, severity of nausea and patient satisfaction with the intervention. Our study revealed no significant differences in rates of postoperative nausea and vomiting between the intervention and standard therapy groups (41.4% v 36.9% p = 0.461). There were no significant differences in secondary outcomes between groups. Chewing gum does not reduce the incidence of PONV after elective LSCS under spinal anaesthesia. Our trial was registered with clinicaltrials.org (NCT04191694).

Project description:IntroductionInvestigating elective and emergency caesarean section (CS) separately is important for a better understanding of birth delivery modes in the sub-Saharan Africa (SSA) region and identifying bottlenecks that prevent favourable childbirth outcomes in SSA. This study aimed at evaluating the prevalences of both CS types, determining their associated socioeconomic factors and their association with early neonatal mortality in SSA.MethodsSSA countries Demographic and Health Surveys data that had collected information on the CS' timing were included in our study. A total of 21 countries were included in this study, with a total of 155 172 institutional live births. Prevalences of both CS types were estimated at the countries' level using household sampling weights. Multilevel models were fitted to identify associated socioeconomic factors of both CS types and their associations with early neonatal mortality.ResultsThe emergency CS prevalence in SSA countries was estimated at 4.6% (95% CI 4.4-4.7) and was higher than the elective CS prevalence estimated at 3.4% (95% CI 3.3-3.6). Private health facilities' elective CS prevalence was estimated at 10.2% (95% CI 9.3-11.2) which was higher than the emergency CS prevalence estimated at 7.7% (95% CI 7.0-8.5). Conversely, in public health facilities, the emergency CS prevalence was estimated at 4.0% (95% CI 3.8-4.2) was higher than the elective CS prevalence estimated at 2.7% (95% CI 2.6-2.8). The richest women were more likely to have birth delivery by both CS types than normal vaginal delivery. Emergency CS was positively associated with early neonatal mortality (adjusted OR=2.37, 95% CI 1.64-3.41), while no association was found with elective CS.ConclusionsFindings suggest shortcomings in pregnancy monitoring, delivery preparation and postnatal care. Beyond antenatal care (ANC) coverage, more attention should be put on quality of ANC, postnatal care, emergency obstetric and newborn care for favourable birth delivery outcomes in SSA.

Project description:IntroductionApproximately 25% of all babies in North America are delivered via Caesarean section (C-section). Though a common surgical procedure, C-section recovery can be painful. Opioids, specifically codeine, are commonly used to ease pain; however, its active metabolite, morphine, passes into breast milk, and may produce unwanted side effects in neonates; therefore, alternatives to opioids are being sought. Reiki is an ancient Japanese form of healing where practitioners transfer healing energy through light touch and positive healing intention. Although 1.2 million Americans use reiki to reduce pain or depression, there is a lack of strong evidence supporting its effectiveness. A recent systematic review showed existing studies to be of poor methodological quality, with the common limitation of lack of blinding. To overcome this issue, the authors used distant reiki to assess its effectiveness in reducing pain following an elective C-section.MethodsIn this randomised, double-blinded study, women who underwent an elective C-section were allocated to either usual care (control, n=40) or three distant reiki sessions in addition to usual care (n=40). Pain was assessed using a visual analogue scale (VAS). The primary endpoint was the Area Under the VAS-Time Curve (AUC) for days 1-3. Secondary measures included: the proportion of women who required opioid medications and dose consumed, rate of healing and vital signs.ResultsAUC for pain was not significantly different in the distant reiki and control groups (mean ± SD; 212.1 ± 104.7 vs 223.1 ± 117.8; p=0.96). There were no significant differences in opioid consumption or rate of healing; however, the distant reiki group had a significantly lower heart rate (74.3 ± 8.1 bpm vs 79.8 ± 7.9 bpm, p=0.003) and blood pressure (106.4 ± 9.7 mmHg vs 111.9 ± 11.0 mmHg, p=0.02) post surgery.ConclusionDistant reiki had no significant effect on pain following an elective C-section. Clinical Trial Registration Number ISRCTN79265996.

Project description:BackgroundThe OptiBIRTH study incorporates a multicentre cluster randomised trial in 15 hospital sites across three European countries. The trial was designed to test a complex intervention aimed at improving vaginal birth after caesarean section (VBAC) rates through increasing women's involvement in their care. Prior to developing a robust standardised model to conduct the health economic analysis, an analysis of a hypothetical cohort was performed to estimate the costs and health effects of VBAC compared to elective repeat caesarean delivery (ERCD) for low-risk women in four European countries.MethodsA decision-analytic model was developed to estimate the costs and the health effects, measured using Quality Adjusted Life Years (QALYs), of VBAC compared with ERCD. A cost-effectiveness analysis for the period from confirmation of pregnancy to 6 weeks postpartum was performed for short-term consequences and during lifetime for long-term consequences, based on a hypothetical cohort of 100,000 pregnant women in each of four different countries; Belgium, Germany, Ireland and Italy. A societal perspective was adopted. Where possible, transition probabilities, costs and health effects were adapted from national data obtained from the respective countries. Country-specific thresholds were used to determine the cost-effectiveness of VBAC compared to ERCD. Deterministic and probabilistic sensitivity analyses were conducted to examine the uncertainty of model assumptions.ResultsWithin a 6-week time horizon, VBAC resulted in a reduction in costs, ranging from €3,334,052 (Germany) to €66,162,379 (Ireland), and gains in QALYs ranging from 6399 (Italy) to 7561 (Germany) per 100,000 women birthing in each country. Compared to ERCD, VBAC is the dominant strategy in all four countries. Applying a lifetime horizon, VBAC is dominant compared to ERCD in all countries except for Germany (probabilistic analysis, ICER: €8609/QALY). In conclusion, compared to ERCD, VBAC remains cost-effective when using a lifetime time.ConclusionsIn all four countries, VBAC was cost-effective compared to ERCD for low-risk women. This is important for health service managers, economists and policy makers concerned with maximising health benefits within limited and constrained resources.

Project description:We aimed to evaluate the reliability of lung ultrasound (LU) to predict admission to the neonatal intensive care unit (NICU) for transient neonatal tachypnoea or respiratory distress syndrome in infants born by caesarean section (CS). A prospective, observational, single-centre study was performed in the delivery room and NICU of Sant'Orsola-Malpighi Hospital in Bologna, Italy. Term and late-preterm infants born by CS were included. LU was performed at 30' and 4 h after birth. LU appearance was graded according to a previously validated three-point scoring system (3P-LUS: type-1, white lung; type-2, black/white lung; type-3, normal lung). Full LUS was also calculated. One hundred infants were enrolled, and seven were admitted to the NICU. The 5 infants with bilateral type-1 lung at birth were all admitted to the NICU. Infants with type-2 and/or type-3 lung were unlikely to be admitted to the NICU. Mean full-LUS was 17 in infants admitted to the NICU, and 8 in infants not admitted. In two separate binary logistic regression models, both the 3P- and the full LUS proved to be independently associated with NICU admission (OR [95% CI] 0.001 [0.000-0.058], P = .001, and 2.890 [1.472-5.672], P = .002, respectively). The ROC analysis for the 3P-LUS yielded an AUC of 0.942 (95%CI, 0.876-0.979; P<.001), while ROC analysis for the full LUS yielded an AUC of 0.978 (95%CI, 0.926-0.997; P<.001). The AUCs for the two LU scores were not significantly different (p = .261).Conclusion: the 3P-LUS performed 30 min after birth proved to be a reliable tool to identify, among term and late preterm infants born to CS, those who will require NICU admission for transient neonatal tachypnoea or respiratory distress syndrome. What is known • Lung ultrasound (LU) has become an attractive diagnostic tool in neonatal settings, and guidelines on point-of-care LU in the neonatal intensive care unit (NICU) have been recently issued. • LU is currently used for diagnosing several neonatal respiratory morbidities and has been also proposed for predicting further intervention, such as NICU admission, need for surfactant treatment or mechanical ventilation in preterm infants. What is new • LU performed 30' after birth and evaluated through a simple three-point scoring system represents a reliable tool to identify, among term and late preterm infants born to caesarean section, those with transient neonatal tachypnoea or respiratory distress syndrome who will require NICU admission. • LU performed in the neonatal period confirms its potential role in ameliorating routine neonatal clinical management.

Project description:BackgroundAlthough antenatal betamethasone is recommended worldwide for women at risk of preterm delivery, concerns persist regarding the long-term effects associated with this treatment. Indeed, adverse events, mainly dose-related, have been reported. The current recommended dose of antenatal betamethasone directly derives from sheep experiments performed in the late 60's and has not been challenged in 45 years. Therefore, randomized trials evaluating novel dose regimens are urgently needed.MethodsA randomised, double blind, placebo-controlled, non-inferiority trial will be performed in 37 French level 3 maternity units. Women with a singleton pregnancy at risk of preterm delivery before 32 weeks of gestation having already received a first 11.4 mg injection of betamethasone will be randomised to receive either a second injection of 11.4 mg betamethasone (full dose arm) or placebo (half dose arm) administered intramuscularly 24 h after the first injection. The primary binary outcome will be the occurrence of severe respiratory distress syndrome (RDS), defined as the need for exogenous intra-tracheal surfactant in the first 48 h of life. Considering that 20% of the pregnant women receiving the full dose regimen would have a neonate with severe RDS, 1571 patients in each treatment group are required to show that the half dose regimen is not inferior to the full dose, that is the difference in severe RDS rate do not exceed 4% (corresponding to a Relative Risk of 20%), with a 1-sided 2.5% type-1 error and a 80% power. Interim analyses will be done after every 300 neonates who reach the primary outcome on the basis of intention-to-treat, using a group-sequential non-inferiority design.DiscussionIf the 50% reduced antenatal betamethasone dose is shown to be non-inferior to the full dose to prevent severe RDS associated with preterm birth, then it should be used consistently in women at risk of preterm delivery and would be of great importance to their children.Trial registrationClinicalTrials.gov identifier: NCT 02897076 (registration date 09/13/2016).

Dataset Information

Antenatal betamethasone and incidence of neonatal respiratory distress after elective caesarean section: pragmatic randomised trial.

Objective

Design

Setting

Participants

Interventions

Outcome measures

Results

Conclusions

Publications

Antenatal betamethasone and incidence of neonatal respiratory distress after elective caesarean section: pragmatic randomised trial.

Similar Datasets

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