Perinatal outcomes of subjects enrolled in a multicenter trial with a waiver of antenatal consent

dc.contributor.authorKatheria, Anup C.
dc.contributor.authorAllman, Phillip
dc.contributor.authorSzychowski, Jeff M.
dc.contributor.authorEssers, Jochen
dc.contributor.authorCarlo, Waldemar A.
dc.contributor.authorSchmölzer, Georg M.
dc.contributor.authorDempsey, Eugene M.
dc.contributor.authorYanowitz, Toby
dc.contributor.authorKaempf, Joseph
dc.contributor.authorVora, Farha
dc.contributor.authorBhat, Shazia
dc.contributor.authorArnell, Kathy
dc.contributor.authorRich, Wade
dc.contributor.authorVarner, Michael
dc.contributor.funderNational Institutes of Health and Child Developmenten
dc.contributor.funderEunice Kennedy Shriver National Institute of Child Health and Human Developmenten
dc.description.abstractObjective This study aimed to determine whether outcomes differed between infants enrolled in the PREMOD2 trial and those otherwise eligible but not enrolled, and whether the use of waiver effected these differences. Study Design: The multicenter PREMOD2 (PREmature infants receiving Milking Or Delayed cord clamping) trial was approved for waiver of antenatal consent by six of the nine sites institutional review boards, while three sites exclusively used antenatal consent. Every randomized subject delivered at a site with a waiver of consent was approached for postnatal consent to allow for data collection. Four of those six sites' IRBs required the study team to attempt antenatal consent when possible. Three sites exclusively used antenatal consent. Results: Enrolled subjects had higher Apgar scores, less use of positive pressure ventilation, a lower rate of bronchopulmonary dysplasia, and a less frequent occurrence of the combined outcome of severe intraventricular hemorrhage or death. A significantly greater number of infants were enrolled at sites with an option of waiver of consent (66 vs. 26%, risk ratio = 2.54, p < 0.001). At sites with an option of either approaching families before delivery or after delivery with a waiver of antenatal consent, those approached prior to delivery refused consent 40% (range 15-74% across six sites) of the time. 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.en
dc.description.statusPeer revieweden
dc.description.versionPublished Versionen
dc.identifier.citationKatheria, A. C., Allman, P., Szychowski, J. M., Essers, J., Carlo, W. A., Schmölzer, G. M., Dempsey, E. M., Yanowitz, T., Kaempf, J., Vora, F., Bhat, S., Arnell, K., Rich, W. and Varner, M. (2020) 'Perinatal outcomes of subjects enrolled in a multicenter trial with a waiver of antenatal consent', American Journal of Perinatology, (10pp). doi: 10.1055/s-0040-1719184en
dc.identifier.journaltitleAmerican Journal of Perinatologyen
dc.publisherThieme Medical Publishers, Inc.en
dc.relation.projectinfo:eu-repo/grantAgreement/NIH/EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT/1R01HD088646-01A1/US/Premature Infants Receiving Cord Milking Or Delayed Cord Clamping/en
dc.rights© 2020. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (
dc.subjectUmbilical-cord milkingen
dc.titlePerinatal outcomes of subjects enrolled in a multicenter trial with a waiver of antenatal consenten
dc.typeArticle (non peer-reviewed)en
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