Randomized controlled trials: not always the “gold standard” for evidence in obstetrics and gynecology

Oyelese, Yinka

doi:10.1016/j.ajog.2023.10.015

Cited by 1 publication

(1 citation statement)

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“…However, given the critical prognosis associated with this pathology and the variability in intraoperative findings among patients, such an approach was deemed necessary [31]. A recent review highlights that randomized controlled trials are not invariably considered the "gold standard" for evidence in obstetrics and gynecology [32].…”

Section: Resultsmentioning

confidence: 99%

Modified one-step conservative surgery for placenta accreta spectrum versus caesarean hysterectomy: The CMNT PAS prospective comparative Non-Randomized pilot study

Abouda,

Aloui,

Marzouk

et al. 2024

Preprint

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Introduction: The surgical procedure known as one-step conservative surgery for placenta accreta spectrum involves the excision of the placenta and its attachment site on the myometrium. We aimed to conduct a non-randomized comparative study between conservative surgical treatment of placenta accreta spectrum and classical caesarean hysterectomy, under the name of the "CMNT PAS" study. To determine the sample size and the expected difference between the two groups, we conduct this pilot study. Study design: It was a monocentric prospective observational study from January 4, 2020, to August 17, 2022. Patients were allocated into two groups: Group Conservative Surgery (CSG) in which the method detailed in prior research by Palacios-Jaraquemada was slightly modified by our team, control group (CG) when the caesarean hysterectomy was performed. Results: Our main goal is to determine the sample size for our principal study and provide adequate data for any other team wishing to study the conservative surgical treatment of placenta accreta spectrum. So, the sample size for a power of 90% and an alpha risk of 5%, the size of each group must be 22 patients. Regarding primary outcomes: estimated blood loss volume was lower in CG compared to CSG but not statistically significant. Conclusion: Our pilot study found that the caesarean hysterectomy is similar to conservative surgical treatment for placenta accreta in estimated blood loss. However, the latter helps preserve uterus and possibly fertility.

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Section: Resultsmentioning

confidence: 99%