Berry, Diane C. http://orcid.org/0000-0002-3274-0818
Thomas, Sonia Davis
Dorman, Karen F.
Ivins, Amber Rose
de los Angeles Abreu, Maria
Young, Laura
Boggess, Kim
Funding for this research was provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (HD086139)
Article History
Received: 13 October 2017
Accepted: 20 November 2018
First Online: 12 December 2018
Ethics approval and consent to participate
: All study sites have obtained Institutional Review Board approval before the start of the study.The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina (Study Number 15–3235); The Ohio State University at Columbus, Ohio (Study Number 2017H0088); University of Pennsylvania, Philadelphia, Pennsylvania (Study Number 826955); University of California, San Diego Maternal Fetal Care Services and the Medical Offices South Women’s Health Services, San Diego, California (Study Number 160660); University of Alabama-Birmingham, Birmingham, Alabama (Study Number 170307003); University of Utah Health Sciences Center, including the LDS Hospital, McKay-Dee Hospital Center, Utah Valley Regional Medical Center (Study Number 00098741), and the Intermountain Medical Center in Salt Lake City, Utah (Study Number 1050647); University of Texas Medical Branch, Galveston, Texas (Study Number 15–0240; University of Texas Memorial Hermann Hospital and the LBJ Hospital Houston, Houston, Texas (Study Number 17-06-1684); and Columbia University, New York, New York (Study Number AAAR2412).Verbal and written consent will be obtained from all women interested in joining the study.Women who meet the inclusion criteria at all of the sites are approached by the physician or nurse and the study is explained. The risks and benefits of participating are reviewed. Joining the study is voluntary and they can stop at any time. Refusing to join the study or stopping the study will not affect their care. After all questions are answered the woman is asked to sign the consent. She is given a copy of the consent. If she has concerns at any time she is encouraged to contact the office where she receives care.
: Not applicable.
: The authors declare that they have no competing interests.
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