An ob-gyn journal has retracted a clinically influential 2016 paper on the use of steroids in women undergoing cesarean delivery, citing questions about the data.
The article, "Antenatal corticosteroid administration before elective caesarean section at term to prevent neonatal respiratory morbidity: a randomized controlled trial," appeared in the European Journal of Obstetrics & Gynecology and Reproductive Biology (EJOG), and was written by a group at Cairo University in Egypt led by Adel Nada.
The study purported to involve nearly 1,300 women – making it the largest analysis of women receiving steroids for the indication in the trial. But Ben Mol, an ob-gyn researcher and data sleuth at Monash Medical Centre in Australia, noted that the paper – which has been cited 32 times, per Clarivate Analytics' Web of Science – was based on a thesis by the second author, M.M. Shafeek. Something in the two articles caught Mol's eye, he told Retraction Watch:
the start and end dates in the thesis deviate from the paper. Also, the female – male baby rate in more than 1200 babies was 59 to 41, which is impossible.
Mol and his colleagues questioned the data – and those from two other currently unretracted papers – in an article they submitted to the EJOG in January 2021, titled "Effectiveness of antenatal corticosteroids at term: Can we trust the data that 'inform' us?" Short answer: No.
Mol noted that new data show that children exposed to steroids via the mother in the antenatal period appear to be at risk of brain damage.
According to the journal:
This article has been retracted at the request of the Editor-in-Chief.
The editorial board has raised concerns regarding the integrity of this paper and remaining in the public domain. It is by far the largest trial of corticosteroids for this indication, overwhelming other similar trials in Cochrane and other systematic reviews and is likely leading to widespread prescription of this drug, which may have serious side effects on fetal brain development. If the data is unreliable, women and babies are being harmed.
As we have not received the original dataset or a satisfactory response from Dr Nada for an explanation regarding our concerns after giving them a month to respond, we have decided to retract this paper.
The data helped inform a 2018 review from the Cochrane Library on the use of corticosteroids for preventing neonatal respiratory morbidity after elective c-sections. Here's the money quotation from that paper:
The results from the four trials are promising, but more high‐quality studies with larger sample sizes that are adequately powered to detect the effect of prophylactic antenatal corticosteroids on outcomes of respiratory morbidity are needed, given the potential of the current studies for bias.
That section, updated in December 2021, now reads:
Evidence from one randomised controlled trial suggests that prophylactic corticosteroids before elective caesarean section at term probably reduces admission to the neonatal intensive care unit for respiratory morbidity. It is uncertain if administration of antenatal corticosteroids reduces the rates of respiratory distress syndrome (RDS) or transient tachypnoea of the neonate (TTN). The overall certainty of the evidence for the primary outcomes was found to be low or very low, apart from the outcome of admission to neonatal special care (all levels) for respiratory morbidity, for which the evidence was of moderate certainty. Therefore, there is currently insufficient data to draw any firm conclusions.
Nada said that when the editors asked for the raw data, he provided the email addresses of his colleagues in Egypt, where the data are only available in hard copy.
Nada told us that he and his colleagues "did not agree" to the retraction. "But what can we do?"
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