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. 2022 Aug 9;8(8):CD006764.
doi: 10.1002/14651858.CD006764.pub4.

Different corticosteroids and regimens for accelerating fetal lung maturation for babies at risk of preterm birth

Myfanwy J Williams  1 , Jenny A Ramson  2 , Fiona C Brownfoot  3
Affiliations

Different corticosteroids and regimens for accelerating fetal lung maturation for babies at risk of preterm birth

Myfanwy J Williams et al. Cochrane Database Syst Rev. .

Abstract

Background: Despite the widespread use of antenatal corticosteroids to prevent respiratory distress syndrome (RDS) in preterm infants, there is currently no consensus as to the type of corticosteroid to use, dose, frequency, timing of use or the route of administration. OBJECTIVES: To assess the effects on fetal and neonatal morbidity and mortality, on maternal morbidity and mortality, and on the child and adult in later life, of administering different types of corticosteroids (dexamethasone or betamethasone), or different corticosteroid dose regimens, including timing, frequency and mode of administration.

Search methods: For this update, we searched Cochrane Pregnancy and Childbirth Group's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (9 May 2022) and reference lists of retrieved studies.

Selection criteria: We included all identified published and unpublished randomised controlled trials or quasi-randomised controlled trials comparing any two corticosteroids (dexamethasone or betamethasone or any other corticosteroid that can cross the placenta), comparing different dose regimens (including frequency and timing of administration) in women at risk of preterm birth. We planned to exclude cross-over trials and cluster-randomised trials. We planned to include studies published as abstracts only along with studies published as full-text manuscripts.

Data collection and analysis: At least two review authors independently assessed study eligibility, extracted data and assessed the risk of bias of included studies. Data were checked for accuracy. We assessed the certainty of the evidence using GRADE.

Main results: We included 11 trials (2494 women and 2762 infants) in this update, all of which recruited women who were at increased risk of preterm birth or had a medical indication for preterm birth. All trials were conducted in high-income countries. Dexamethasone versus betamethasone Nine trials (2096 women and 2319 infants) compared dexamethasone versus betamethasone. All trials administered both drugs intramuscularly, and the total dose in the course was consistent (22.8 mg or 24 mg), but the regimen varied. We assessed one new study to have no serious risk of bias concerns for most outcomes, but other studies were at moderate (six trials) or high (two trials) risk of bias due to selection, detection and attrition bias. Our GRADE assessments ranged between high- and low-certainty, with downgrades due to risk of bias and imprecision. Maternal outcomes The only maternal primary outcome reported was chorioamnionitis (death and puerperal sepsis were not reported). Although the rate of chorioamnionitis was lower with dexamethasone, we did not find conclusive evidence of a difference between the two drugs (risk ratio (RR) 0.71, 95% confidence interval (CI) 0.48 to 1.06; 1 trial, 1346 women; moderate-certainty evidence). The proportion of women experiencing maternal adverse effects of therapy was lower with dexamethasone; however, there was not conclusive evidence of a difference between interventions (RR 0.63, 95% CI 0.35 to 1.13; 2 trials, 1705 women; moderate-certainty evidence). Infant outcomes We are unsure whether the choice of drug makes a difference to the risk of any known death after randomisation, because the 95% CI was compatible with both appreciable benefit and harm with dexamethasone (RR 1.03, 95% CI 0.66 to 1.63; 5 trials, 2105 infants; moderate-certainty evidence). The choice of drug may make little or no difference to the risk of RDS (RR 1.06, 95% CI 0.91 to 1.22; 5 trials, 2105 infants; high-certainty evidence). While there may be little or no difference in the risk of intraventricular haemorrhage (IVH), there was substantial unexplained statistical heterogeneity in this result (average (a) RR 0.71, 95% CI 0.28 to 1.81; 4 trials, 1902 infants; I² = 62%; low-certainty evidence). We found no evidence of a difference between the two drugs for chronic lung disease (RR 0.92, 95% CI 0.64 to 1.34; 1 trial, 1509 infants; moderate-certainty evidence), and we are unsure of the effects on necrotising enterocolitis, because there were few events in the studies reporting this outcome (RR 5.08, 95% CI 0.25 to 105.15; 2 studies, 441 infants; low-certainty evidence). Longer-term child outcomes Only one trial consistently followed up children longer term, reporting at two years' adjusted age. There is probably little or no difference between dexamethasone and betamethasone in the risk of neurodevelopmental disability at follow-up (RR 1.02, 95% CI 0.85 to 1.22; 2 trials, 1151 infants; moderate-certainty evidence). It is unclear whether the choice of drug makes a difference to the risk of visual impairment (RR 0.33, 95% CI 0.01 to 8.15; 1 trial, 1227 children; low-certainty evidence). There may be little or no difference between the drugs for hearing impairment (RR 1.16, 95% CI 0.63 to 2.16; 1 trial, 1227 children; moderate-certainty evidence), motor developmental delay (RR 0.89, 95% CI 0.66 to 1.20; 1 trial, 1166 children; moderate-certainty evidence) or intellectual impairment (RR 0.97, 95% CI 0.79 to 1.20; 1 trial, 1161 children; moderate-certainty evidence). However, the effect estimate for cerebral palsy is compatible with both an important increase in risk with dexamethasone, and no difference between interventions (RR 2.50, 95% CI 0.97 to 6.39; 1 trial, 1223 children; low-certainty evidence). No trials followed the children beyond early childhood. Comparisons of different preparations and regimens of corticosteroids We found three studies that included a comparison of a different regimen or preparation of either dexamethasone or betamethasone (oral dexamethasone 32 mg versus intramuscular dexamethasone 24 mg; betamethasone acetate plus phosphate versus betamethasone phosphate; 12-hourly betamethasone versus 24-hourly betamethasone). The certainty of the evidence for the main outcomes from all three studies was very low, due to small sample size and risk of bias. Therefore, we were limited in our ability to draw conclusions from any of these studies.

Authors' conclusions: Overall, it remains unclear whether there are important differences between dexamethasone and betamethasone, or between one regimen and another. Most trials compared dexamethasone versus betamethasone. While for most infant and early childhood outcomes there may be no difference between these drugs, for several important outcomes for the mother, infant and child the evidence was inconclusive and did not rule out significant benefits or harms. The evidence on different antenatal corticosteroid regimens was sparse, and does not support the use of one particular corticosteroid regimen over another.

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Conflict of interest statement

MW: is employed by the University of Liverpool as a Research Associate for Cochrane Pregnancy and Childbirth. This role is supported by funding from the UNDP‐UNFPA‐UNICEF‐WHO‐World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP) to Cochrane Pregnancy and Childbirth (University of Liverpool). As part of this role, MW attends World Health Organization (WHO) guideline meetings and conducts reviews, such as this one, to support the programme of work for WHO.

JR: was engaged by the Burnett Institute, Melbourne, Australia to contribute to evidence synthesis to support development of WHO guidelines on antenatal corticosteroids for improving preterm birth outcomes. This included preparing an Evidence‐to‐Decision Framework based on this review and attending WHO guideline meetings.

FB: is an Obstetrician at Mercy Hospital for Women, Melbourne Australia and was involved in the A*STEROID study as part of a recruiting centre, but had no involvement in the assessment or data extraction for the A*STEROID study.

Figures

1
1
Applying the trustworthiness screening tool criteria. TST: Trustworthiness Screening Tool.
2
2
Study flow diagram.
3
3
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
4
4
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 1: Chorioamnionitis
1.2
1.2. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 2: Any known death after randomisation (fetal, neonatal, child, child as adult)
1.3
1.3. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 3: Respiratory distress syndrome
1.4
1.4. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 4: Intraventricular haemorrhage
1.5
1.5. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 5: Death (childhood)
1.6
1.6. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 6: Neurodevelopmental disability at follow‐up (childhood)
1.7
1.7. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 7: Maternal infection requiring use of antibiotics
1.8
1.8. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 8: Maternal adverse effects of therapy
1.9
1.9. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 9: Fetal death
1.10
1.10. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 10: Neonatal death
1.11
1.11. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 11: Apgar score < 7 at 5 minutes
1.12
1.12. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 12: Birthweight (mean; kg)
1.13
1.13. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 13: Low birthweight
1.14
1.14. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 14: Length at birth (mean, cm)
1.15
1.15. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 15: Head circumference at birth (mean, cm)
1.16
1.16. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 16: Neonatal intensive care unit admission
1.17
1.17. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 17: Mechanical ventilation
1.18
1.18. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 18: Duration of mechanical ventilation (days, mean)
1.19
1.19. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 19: Moderate/severe respiratory distress syndrome
1.20
1.20. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 20: Chronic lung disease
1.21
1.21. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 21: Bronchopulmonary dysplasia
1.22
1.22. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 22: Severe intraventricular haemorrhage
1.23
1.23. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 23: Periventricular leukomalacia
1.24
1.24. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 24: Neonatal sepsis
1.25
1.25. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 25: Neonatal infection in first 48 hours
1.26
1.26. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 26: Necrotising enterocolitis
1.27
1.27. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 27: Retinopathy of prematurity
1.28
1.28. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 28: Patent ductus arteriosus
1.29
1.29. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 29: Fetal heart rate, bpm (day 2)
1.31
1.31. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 31: Accelerations per hour
1.32
1.32. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 32: Fetal movements in 30 minutes
1.33
1.33. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 33: Fetal movements per hour (maternal perception)
1.34
1.34. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 34: Fetal movements per hour (ultrasound)
1.36
1.36. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 36: Fetal breathing movements per hour
1.37
1.37. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 37: Duration of breathing time at 2 days (seconds in 30 minutes)
1.38
1.38. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 38: Weight at 2 years (mean kg)
1.39
1.39. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 39: Height at 2 years (mean cm)
1.40
1.40. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 40: Head circumference at 2 years (mean cm)
1.41
1.41. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 41: Systolic blood pressure (child, mean mm Hg)
1.42
1.42. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 42: Diastolic blood pressure (child, mean mm Hg)
1.43
1.43. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 43: Visual impairment
1.44
1.44. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 44: Hearing impairment
1.45
1.45. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 45: Developmental delay – motor (mild/moderate/severe)
1.46
1.46. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 46: Developmental delay – motor (moderate/severe only)
1.47
1.47. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 47: Developmental delay – cognitive or language  (moderate/severe only)
1.48
1.48. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 48: Developmental delay – cognitive or language  (mild/moderate/severe)
1.49
1.49. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 49: Cerebral palsy
1.50
1.50. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 50: Educational achievement – cognitive score (mean, BSID‐III)
1.51
1.51. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 51: Educational achievement – language score (mean, BSID‐III)
1.52
1.52. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 52: Educational achievement – motor score (mean, BSID‐III)
1.53
1.53. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 53: Childhood behaviour checklist (mean total score)
1.54
1.54. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 54: Postnatal length of stay (mean, days)
1.55
1.55. Analysis
Comparison 1: Dexamethasone versus betamethasone – subgrouped by regimen, all outcomes, Outcome 55: Neonatal intensive care unit stay (mean; days)
2.1
2.1. Analysis
Comparison 2: Dexamethasone: oral versus intramuscular (IM), Outcome 1: Neonatal death
2.2
2.2. Analysis
Comparison 2: Dexamethasone: oral versus intramuscular (IM), Outcome 2: Respiratory distress syndrome
2.3
2.3. Analysis
Comparison 2: Dexamethasone: oral versus intramuscular (IM), Outcome 3: Intraventricular haemorrhage
2.4
2.4. Analysis
Comparison 2: Dexamethasone: oral versus intramuscular (IM), Outcome 4: Birthweight (kg, mean)
2.5
2.5. Analysis
Comparison 2: Dexamethasone: oral versus intramuscular (IM), Outcome 5: Neonatal sepsis
2.6
2.6. Analysis
Comparison 2: Dexamethasone: oral versus intramuscular (IM), Outcome 6: Necrotising enterocolitis
3.1
3.1. Analysis
Comparison 3: Betamethasone acetate + phosphate (beta a+p) versus betamethasone phosphate (beta p), Outcome 1: Neonatal death
3.2
3.2. Analysis
Comparison 3: Betamethasone acetate + phosphate (beta a+p) versus betamethasone phosphate (beta p), Outcome 2: Respiratory distress syndrome
3.3
3.3. Analysis
Comparison 3: Betamethasone acetate + phosphate (beta a+p) versus betamethasone phosphate (beta p), Outcome 3: Intraventricular haemorrhage
3.4
3.4. Analysis
Comparison 3: Betamethasone acetate + phosphate (beta a+p) versus betamethasone phosphate (beta p), Outcome 4: Birthweight (mean, kg)
3.5
3.5. Analysis
Comparison 3: Betamethasone acetate + phosphate (beta a+p) versus betamethasone phosphate (beta p), Outcome 5: Low birthweight
3.6
3.6. Analysis
Comparison 3: Betamethasone acetate + phosphate (beta a+p) versus betamethasone phosphate (beta p), Outcome 6: Neonatal intensive care unit admission
3.7
3.7. Analysis
Comparison 3: Betamethasone acetate + phosphate (beta a+p) versus betamethasone phosphate (beta p), Outcome 7: Bronchopulmonary dysplasia
3.8
3.8. Analysis
Comparison 3: Betamethasone acetate + phosphate (beta a+p) versus betamethasone phosphate (beta p), Outcome 8: Periventricular leukomalacia
4.1
4.1. Analysis
Comparison 4: Betamethasone 12‐hourly versus 24‐hourly dosing , Outcome 1: Perinatal death
4.2
4.2. Analysis
Comparison 4: Betamethasone 12‐hourly versus 24‐hourly dosing , Outcome 2: Respiratory distress syndrome
4.3
4.3. Analysis
Comparison 4: Betamethasone 12‐hourly versus 24‐hourly dosing , Outcome 3: Intraventricular haemorrhage
4.4
4.4. Analysis
Comparison 4: Betamethasone 12‐hourly versus 24‐hourly dosing , Outcome 4: Maternal fever
4.5
4.5. Analysis
Comparison 4: Betamethasone 12‐hourly versus 24‐hourly dosing , Outcome 5: Birthweight (mean, kg)
4.6
4.6. Analysis
Comparison 4: Betamethasone 12‐hourly versus 24‐hourly dosing , Outcome 6: Small‐for‐gestational age
4.7
4.7. Analysis
Comparison 4: Betamethasone 12‐hourly versus 24‐hourly dosing , Outcome 7: Neonatal intensive care unit admission
4.8
4.8. Analysis
Comparison 4: Betamethasone 12‐hourly versus 24‐hourly dosing , Outcome 8: Chronic lung disease
4.9
4.9. Analysis
Comparison 4: Betamethasone 12‐hourly versus 24‐hourly dosing , Outcome 9: Neonatal sepsis
4.10
4.10. Analysis
Comparison 4: Betamethasone 12‐hourly versus 24‐hourly dosing , Outcome 10: Neonatal antibiotic use (> 5 days)
4.11
4.11. Analysis
Comparison 4: Betamethasone 12‐hourly versus 24‐hourly dosing , Outcome 11: Necrotising enterocolitis
4.12
4.12. Analysis
Comparison 4: Betamethasone 12‐hourly versus 24‐hourly dosing , Outcome 12: Retinopathy of prematurity
4.13
4.13. Analysis
Comparison 4: Betamethasone 12‐hourly versus 24‐hourly dosing , Outcome 13: Postpartum maternal length of stay (days, mean)
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References

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Shanks 2010 {published data only}
    1. Shanks A, Gross G, Shim T, Allsworth J, Moga C, Sadovsky Y, et al. Antenatal steroids for enhancement of fetal lung maturity after 34 weeks: lung maturity and antenatal steroids (LUMAS) study. American Journal of Obstetrics and Gynecology 2008;199(6 Suppl 1):S58. - PMC - PubMed
    1. Shanks A, Gross G, Shim T, Allsworth J, Sadovsky Y, Bildirici I. Administration of steroids after 34 weeks of gestation enhances fetal lung maturity profiles. American Journal of Obstetrics and Gynecology 2010;203(1):47.e1-47.e5. - PMC - PubMed
Sukarna 2021 {published data only}
    1. ISRCTN16613220. Is there a difference between 2 doses of 12 mg of dexamethasone given 12 hours apart compared with 4 doses of 6 mg dexamethasone given 12 hours apart in terms of the dosing regimen's impact on causing high blood sugar in the mother when dexamethasone is given to minimise risk of prematurity complications? [Antenatal dexamethasone regimen in mild gestational diabetes: a randomized controlled trial]. trialsearch.who.int/Trial2.aspx?TrialID=ISRCTN16613220 (first received 13 February 2018). [CENTRAL: CN-01895411]
    1. Sukarna N, Tan PC, Hong JG, Sulaiman S, Omar SZ. Glycemic control following two regimens of antenatal corticosteroids in mild gestational diabetes: a randomized controlled trial. Archives of Gynecology and Obstetrics 2021;304:345-53. [DOI: 10.1007/s00404-020-05950-3] - DOI - PubMed
Vytiska‐Binstorfer 1985 {published data only}
    1. Vytiska-Binstorfer E, Salzer H, Langer M, Lohninger A, Simbruner G. Clinical randomised trial: stimulation of fetal surfactant production by carnitine combined with a reduced betamethasone dose. Archives of Gynaecology 1985;237(Suppl 1):399.
Whitt 1976 {published data only}
    1. Whitt GG, Buster JE, Killam AP, Scragg WH. A comparison of two glucocorticoid regimens for acceleration of fetal lung maturation in premature labour. American Journal of Obstetrics and Gynecology 1976;124:479-82. - PubMed

References to studies awaiting assessment

Chen 2005 (TST) {published data only}
    1. Chen CY, Wang KG, Chang TY, Chen CP, Loo JH. Effects of antenatal betamethasone and dexamethasone in preterm neonates. Taiwanese Journal of Obstetrics and Gynaecology 2005;44(3):247-51.
Chhatrala 2015 {published data only}
    1. Chhatrala JJ, Chawada R. Comparative study of dexamethasone and betamethasone for women at risk of preterm birth. International Journal of Reproduction, Contraception, Obstetrics and Gynecology 2015;4(4):1000-3.
Danesh 2012 (TST) {published data only}
    1. Danesh A, Janghorbani M, Khalatbari S. Effects of antenatal corticosteroids on maternal serum indicators of infection in women at risk for preterm delivery: a randomized trial comparing betamethasone and dexamethasone. Journal of Research in Medical Sciences 2012;17(10):911-7. - PMC - PubMed
Gupta 2019 (TST) {published data only}
    1. Gupta P, Sharma S, Kumar V. A randomised controlled trial of 12 hours vs 24 hours betamethasone dosing interval in preterm premature rupture of membranes for prevention of respiratory distress syndrome (RDS) in neonates. Journal of Medical Science and Clinical Research 2019;7(8):669-74. [CENTRAL: CN-02218250]
Kashanian 2018 (TST) {published data only}
    1. IRCT201402072624N11. Betamethasone administration in preterm labor [A comparison between the effect of the two methods of 12 versus 24 hours interval of betamethasone administration on neonatal respiratory distress syndrome in women with preterm labor distress syndrome]. trialsearch.who.int/Trial2.aspx?TrialID=IRCT201402072624N11 (first received 25 March 2014). [CENTRAL: CN-01880680]
    1. Kashanian M, Eshraghi N, Sheikhansari N, Bordbar A, Khatami E. Comparison between two doses of betamethasone administration with 12 hours vs. 24 hours intervals on prevention of respiratory distress syndrome: a randomised trial. Journal of Obstetrics and Gynaecology 2018;38(6):770-6. [CENTRAL: CN-01665275] [EMBASE: 621208178] [PMID: ] - PubMed
Rasool 2017 (TST) {published data only}
    1. Rasool A, Farooq U, Nazir QU, Durani HB. Efficacy of two regimens of dexamethasone for Management of preterm labour: pilot study. Journal of Ayub Medical College, Abbottabad 2017;29(3):393-7. [CENTRAL: CN-01914063] [PMID: ] - PubMed
Romejko‐Wolniewicz 2013 {published data only}
    1. Romejko-Wolniewicz E, Oleszczuk L, Zaręba-Szczudlik J, Czajkowski K. Dosage regimen of antenatal steroids prior to preterm delivery and effects on maternal and neonatal outcomes. Journal of Maternal-Fetal and Neonatal Medicine 2013;26(3):237-41. - PubMed
Tehrani 2014 (TST) {published data only}
    1. IRCT201212307513N2. A comparison between betamethasone and dexamethasone on biophysical profile in 28wk – 32wk pregnant women at risk of preterm labor [A comparison between betamethasone and dexamethasone on biophysical profile]. trialsearch.who.int/Trial2.aspx?TrialID=IRCT201212307513N2 (first received 27 December 2013). [CENTRAL: CN-01805875]
    1. Tehrani HG, Khani B, Komrani Z. Comparison of the effect of betamethasone versus dexamethasone on the amniotic fluid index in the women at risk of preterm labor. Journal of Research in Medical Sciences 2014;19(12):1124-8. [CENTRAL: CN-01077722] [EMBASE: 603145530] - PMC - PubMed
Yahya 2021 (TST) {published data only}
    1. NCT03446937. Effect of antenatal corticosteroids on neonatal morbidity. clinicaltrials.gov/show/NCT03446937 (27 February 2018). [CENTRAL: CN-01483469]
    1. Yahya A, Sulayman H, Abdulkadir I, Biliaminu B. Effect of antenatal corticosteroids in late preterm delivery: a randomised controlled trial. BJOG: an International Journal of Obstetrics and Gynaecology 2021;128(Suppl 2):104-5. [CENTRAL: CN-02284999] [EMBASE: 635301573]

References to ongoing studies

IRCT2015120415634N2 {published data only}
    1. IRCT2015120415634N2. The effect of antenatal intramuscular administration of two doses of betamethasone every 12 hours on acute pulmonary complications in preterm infants born [Comparing of antenatal intramuscular administration of two doses of betamethasone every 12 hours with standard method every 24 hours on acute neonatal pulmonary complications in preterm infants born from women with preterm premature of membrane]. trialsearch.who.int/Trial2.aspx?TrialID=IRCT2015120415634N2 (first received 27 September 2017). [CENTRAL: CN-01886227]
NCT01697098 {published data only}
    1. NCT01697098. Dexamethasone for preterm labour [Dexamethasone dosing interval: 12 or 24 hours apart? A randomized, clinical trial]. clinicaltrials.gov/show/NCT01697098 (first received 2 October 2012). [CENTRAL: CN-01537911]
NCT04494529 {published data only}
    1. NCT04494529. Single dose antenatal corticosteroids (SNACS) for women at risk of preterm birth [Single dose antenatal corticosteroids (SNACS) pilot randomized control trial for women at risk of preterm birth]. clinicaltrials.gov/show/NCT04494529 (first received 31 July 2020). [CENTRAL: CN-02145746]
NCT05114096 {published data only}
    1. NCT05114096. Single dose of antenatal corticosteroids for pregnancies at risk of preterm delivery (SNACS). clinicaltrials.gov/show/NCT05114096 (first received 9 November 2021). [CENTRAL: CN-02339354]
Schmitz 2019 {published data only}
    1. EUCTR2016-001486-90-FR. BETADOSE: dose reduction of antenatal betamethasone given to prevent the neonatal complications associated with very preterm birth: a randomized, multicenter, double blind placebo-controlled non inferiority trial [Dose reduction of antenatal betamethasone given to prevent the neonatal complications associated with very preterm birth: a randomized, multicentre, double blind placebo-controlled non inferiority trial. BETADOSE – BETADOSE]. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2016-001486-90-FR (first received 27 April 2016). [CENTRAL: CN-02169007]
    1. NCT02897076. Dose reduction of antenatal betamethasone given to prevent the neonatal complications associated with very preterm birth [Dose reduction of antenatal betamethasone given to prevent the neonatal complications associated with very preterm birth: a randomized, multicentre, double blind placebo-controlled non inferiority trial]. clinicaltrials.gov/show/NCT02897076 (first received 7 September 2016). [CENTRAL: CN-01520740]
    1. Schmitz T, Alberti C, Ursino M, Baud O, Aupiais C, BETADOSE study group and the GROG (Groupe de Recherche en Gynecologie Obstetrique). Full versus half dose of antenatal betamethasone to prevent severe neonatal respiratory distress syndrome associated with preterm birth: study protocol for a randomised, multicenter, double blind, placebo-controlled, non-inferiority trial (BETADOSE). BMC Pregnancy and Childbirth 2019;19(1):67. [CENTRAL: CN-01787973] [EMBASE: 626359019] [PMID: ] - PMC - PubMed
    1. Schmitz T, Doret M, Sentilhes L, Alberti C, Ursino M, Aupiais C, et al. Dose reduction of antenatal betamethasone in women at risk of very preterm delivery (BETADOSE trial). American Journal of Obstetrics and Gynecology 2021;224(2 Suppl):S723-4. [CENTRAL: CN-02247756] [EMBASE: 2010870067]
TCTR20200729002 {published data only}
    1. TCTR20200729002. Effect of different doses of steroid on respiratory distress syndrome in moderate to late preterm neonates born between 320-366 weeks of gestation: a randomized controlled trial. trialsearch.who.int/Trial2.aspx?TrialID=TCTR20200729002 (first received 29 July 2020). [CENTRAL: CN-02189966]
WHO ACTION III {published data only}
    1. CTRI/2021/03/032429. Improving newborn survival in preterm birth [WHO ACTION-III: a multi-country, multi-centre, three-arm, parallel group, double-blind, placebo-controlled, randomized trial of two doses of antenatal corticosteroids for women with a high probability of birth in the late preterm period in hospitals in low-resource countries to improve newborn outcomes – WHO ACTION-III]. trialsearch.who.int/Trial2.aspx?TrialID=CTRI/2021/03/032429 (first received 24 November 2021). [CENTRAL: CN-02280513]
    1. ISRCTN11434567. Antenatal corticosteroids for women at risk of birth in the late preterm period to improve newborn outcomes [ACTION III: a multi-country, multi-centre, three-arm, parallel group, double-blind, placebo-controlled, randomized trial of two doses of antenatal corticosteroids for women with a high probability of birth in the late preterm period in hospitals in low-resource countries to improve newborn outcomes]. trialsearch.who.int/Trial2.aspx?TrialID=ISRCTN11434567 (first received 7 June 2021). [CENTRAL: CN-02280191]
    1. PACTR202105463874444. The WHO ACTION (Antenatal CorticosTeroids for Improving Outcomes in Preterm Newborns) Trials [ACTION III: a multi-country, multi-centre, three-arm, parallel group, double-blind, placebo-controlled, randomized trial of two doses of antenatal corticosteroids for women with a high probability of birth in the late preterm period in hospitals in low-resource countries to improve newborn outcomes]. trialsearch.who.int/Trial2.aspx?TrialID=PACTR202105463874444 (first received 18 May 2021). [CENTRAL: CN-02281089]

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References to other published versions of this review

Brownfoot 2008
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