Perinatal Outcomes of Subjects Enrolled in a Multicenter Trial with a Waiver of Antenatal Consent
Conclusion PREMOD2 trial demonstrated analytical validity limitations because of the variable mix of antenatal consent and waiver of consent. A waiver of antenatal consent for minimal risk interventional trials conducted during the intrapartum period will be more successful in enrolling a representative sample of low and high-risk infants if investigators are able to enroll all eligible subjects.
Clinical Trial Registration ClinicalTrials.gov identifier: NCT03019367.
Key Points
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Source: American Journal of Perinatology - Category: Perinatology & Neonatology Authors: Katheria, Anup C. Allman, Phillip Szychowski, Jeff M. Essers, Jochen Carlo, Waldemar A. Schm ölzer, Georg M. Dempsey, Eugene Yanowitz, Toby Kaempf, Joseph Vora, Farha Bhat, Shazia Arnell, Kathy Rich, Wade Varner, Michael Tags: Original Article Source Type: research