Perinatal Outcomes of Subjects Enrolled in a Multicenter Trial with a Waiver of Antenatal Consent

Anup C. Katheria; Phillip Allman; Jeff M. Szychowski; Jochen Essers; Waldemar A. Carlo; Georg M. Schmölzer; Eugene Dempsey; Toby Yanowitz; Joseph Kaempf; Farha Vora; Shazia Bhat; Kathy Arnell; Wade Rich; Michael Varner

doi:10.1055/s-0040-1719184

American Journal of Perinatology, Table of Contents

Am J Perinatol 2022; 39(08): 904-908
DOI: 10.1055/s-0040-1719184

Original Article

Perinatal Outcomes of Subjects Enrolled in a Multicenter Trial with a Waiver of Antenatal Consent

Anup C. Katheria

¹Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, California

,

Phillip Allman

²Department of Biostatistics, The UAB School of Public Health, Birmingham, Alabama

,

Jeff M. Szychowski

²Department of Biostatistics, The UAB School of Public Health, Birmingham, Alabama

,

Jochen Essers

³Department of Pediatrics, University of Ulm, Ulm, Germany

,

Waldemar A. Carlo

⁴Department of Pediatrics, University of Alabama, Birmingham, Alabama

,

Georg M. Schmölzer

⁵Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada

,

Eugene Dempsey

⁶Department of Paediatrics and INFANT Centre, University College Cork, Cork, Ireland

,

Toby Yanowitz

⁷Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania

,

Joseph Kaempf

⁸Women and Children's Services, Providence St. Vincent Medical Center, Portland, Oregon

,

Farha Vora

⁹Department of Pediatrics, Loma Linda University, Loma Linda, California

,

Shazia Bhat

¹⁰Department of Pediatrics, ChristianaCare Health System, Newark, Delaware

,

Kathy Arnell

¹Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, California

,

Wade Rich

¹Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, California

,

Michael Varner

¹¹Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, Utah

› Author Affiliations

Abstract

Objective 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.

Clinical Trial Registration ClinicalTrials.gov identifier: NCT03019367.

Key Points

Waiver of consent is when informed consent cannot be obtained prior to delivery.
Cord milking is a procedure in which blood is pushed (stripped) two to four times towards the newborn.
Delayed clamping means the umbilical cord is not clamped immediately after birth.

Keywords

cord milking - delayed cord clamping - waiver of consent

Full Text

References

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