Dataset Information

Corticosteroids to safely reduce neonatal respiratory morbidity after late preterm and term planned caesarean section birth? A randomised placebo-controlled feasibility study.

ABSTRACT:

Objectives

To assess the feasibility of conducting a randomised placebo-controlled trial of corticosteroids prior to planned caesarean section from 35⁺⁰ to 39⁺⁶ weeks.

Design

A triple-blind, placebo-controlled, parallel, trial randomised at the participant level (1:1 ratio). Additional feasibility data obtained by questionnaires from trial participants and women who declined trial participation, and focus groups with local site researchers and clinicians.

Setting

Three obstetric units in New Zealand including tertiary and secondary care; public and private care, and research active and non-active units.

Participants

Women undergoing a planned caesarean section from 35⁺⁰ to 39⁺⁶ weeks; local site researchers and clinicians.

Interventions

Two doses of 11.4 mg betamethasone or saline placebo. Questionnaires and focus group meetings.

Primary and secondary outcome measures

Primary outcome: trial recruitment rate of eligible women.

Secondary outcomes

trial recruitment by gestational age, site and delivery indication; proportion of babies who completed measurements of blood glucose concentrations as per protocol; overall incidence neonatal respiratory distress requiring >60 min of respiratory support; overall incidence of neonatal hypoglycaemia, and barriers and enablers to trial participation by participants, researchers and clinicians.

Results

The recruitment rate was 8.9% (88/987) overall and 11.2% (88/789) for those approached about the trial. Neonatal blood glucose concentrations were measured as per protocol in 87/92 (94.6%) babies. For potential participants, key enablers to participation were contributing to research, a feeling of relevance and a good understanding; key barriers were a lack of understanding and concerns over safety. For researchers and clinicians, themes representing enablers and barriers included relevance, communication and awareness, influences on women's decision-making, resource challenges and trial process practicalities.

Conclusions

Some women are willing to participate in a randomised placebo-controlled trial of corticosteroids prior to a planned caesarean section birth at late preterm and term gestations. Participation in such a trial can be enhanced.

SUBMITTER: Chan J

PROVIDER: S-EPMC9454046 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Corticosteroids to safely reduce neonatal respiratory morbidity after late preterm and term planned caesarean section birth? A randomised placebo-controlled feasibility study.

Chan Johanna J Mackay Laura L Bloomfield Frank F Crowther Caroline C Lee Arier A Morris Jonathan M JM Hay Rebecca R Oakes-Ter Bals Mariska M Thurnell Christopher C De Jong Phoebe P Carlsen Victoria V Williams Tracey T Groom K M KM

BMJ open 20220907 9

<h4>Objectives</h4>To assess the feasibility of conducting a randomised placebo-controlled trial of corticosteroids prior to planned caesarean section from 35<sup>+0</sup> to 39<sup>+6</sup> weeks.<h4>Design</h4>A triple-blind, placebo-controlled, parallel, trial randomised at the participant level (1:1 ratio). Additional feasibility data obtained by questionnaires from trial participants and women who declined trial participation, and focus groups with local site researchers and clinicians.<h4> ...[more]

PMID: 36691173

Similar Datasets

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:ObjectiveThe objective of this study was to determine whether antenatal corticosteroid exposure has a differential association with preterm neonatal morbidity among women with and without diabetes.Study designSecondary analysis of an observational cohort of 115,502 women and their neonates born in 25 U.S. hospitals (2008-2011). Women who delivered at 230/7 to 336/7 weeks' gestation and received antenatal corticosteroids were compared with those who did not receive antenatal corticosteroids. Women with a stillbirth and women who delivered a neonate that was not resuscitated were excluded. The primary outcome was neonatal respiratory distress syndrome or death within 48 hours. Secondary outcomes included composite neonatal morbidity (respiratory distress syndrome, necrotizing enterocolitis, grades 3-4 intraventricular hemorrhage, sepsis, or death) and mechanical ventilation. Multivariable modified Poisson regression was used to estimate the association between antenatal corticosteroid exposure and neonatal outcomes. Maternal diabetes (pregestational and gestational) was evaluated as a potential effect modifier, and sensitivity analyses were conducted to evaluate whether receipt of a partial, single, or multiple course(s) of antenatal corticosteroids influenced results.ResultsA total of 4,429 women with 5,259 neonates met inclusion criteria: 3,716 (83.9%) women received antenatal corticosteroids and 713 (16.1%) did not. Of the 510 diabetic women (181 pregestational and 329 gestational), 439 (86.1%) received antenatal corticosteroids. Of the 3,919 nondiabetic women, 3,277 (83.6%) received antenatal corticosteroids. Antenatal corticosteroid exposure was not associated with respiratory distress syndrome or early death (adjusted relative risk [aRR] = 0.94, 95% confidence interval [CI]: 0.85-1.04), composite neonatal morbidity (aRR = 0.98, 95% CI: 0.89-1.07), or mechanical ventilation (aRR = 0.95, 95% CI: 0.86-1.05). There was no significant effect modification of maternal diabetes on the relationship between antenatal corticosteroids and neonatal outcomes (p > 0.05), and outcomes were similar in sensitivity analyses of partial, single, or multiple courses of corticosteroids.DiscussionAntenatal corticosteroid administered to reduce preterm neonatal morbidity does not appear to have a differential association among women with diabetes compared with those without.Key points· Antenatal corticosteroids are used ubiquitously in women with and without diabetes.. · Maternal diabetes does not appear to modify the neonatal effect of antenatal corticosteroids.. · Larger studies of antenatal corticosteroids are needed to confirm our findings in diabetic women..

Project description:BackgroundFull dilatation caesarean sections are associated with recurrent early spontaneous preterm birth and late miscarriage. The risk following first stage caesarean sections, are less well defined, but appears to be increased in late-first stage of labour. The mechanism for this increased risk of late miscarriage and early spontaneous preterm birth in these women is unknown and there are uncertainties with regards to clinical management. Current predictive models of preterm birth (based on transvaginal ultrasound and quantitative fetal fibronectin) have not been validated in these women and it is unknown whether the threshold to define a short cervix (≤25 mm) is reliable in predicting the risk of preterm birth. In addition the efficacy of standard treatments or whether benefit may be derived from prophylactic interventions such as a cervical cerclage is unknown.MethodsThere are three distinct components to the CRAFT project (CRAFT-OBS, CRAFT-RCT and CRAFT-IMG).Craft-obsObservational Study; To evaluate subsequent pregnancy risk of preterm birth in women with a prior caesarean section in established labour. This prospective study of cervical length and quantitative fetal fibronectin data will establish a predictive model of preterm birth.Craft-rctRandomised controlled trial arm; To assess treatment for short cervix in women at high risk of preterm birth following a fully dilated caesarean section.Craft-imgImaging sub-study; To evaluate the use of MRI and transvaginal ultrasound imaging of micro and macrostructural cervical features which may predispose to preterm birth in women with a previous fully dilated caesarean section, such as scar position and niche.DiscussionThe CRAFT project will quantify the risk of preterm birth or late miscarriage in women with previous in-labour caesarean section, define the best management and shed light on pathological mechanisms so as to improve the care we offer to women and their babies.Trial registrationCRAFT was prospectively registered on 25th November 2019 with the ISRCTN registry ( https://doi.org/10.1186/ISRCTN15068651 ).

Dataset Information

Corticosteroids to safely reduce neonatal respiratory morbidity after late preterm and term planned caesarean section birth? A randomised placebo-controlled feasibility study.

Objectives

Design

Setting

Participants

Interventions

Primary and secondary outcome measures

Secondary outcomes

Results

Conclusions

Publications

Corticosteroids to safely reduce neonatal respiratory morbidity after late preterm and term planned caesarean section birth? A randomised placebo-controlled feasibility study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets