<?xml version="1.0" encoding="UTF-8"?><protocol_summary><protocol><id>15667</id><no>MATERNA-PREP</no><status>Open</status><title>EASE Study: A randomized, controlled study to EvAluate the Safety and Effectiveness of the Materna Prep Device to pre-stretch the vaginal canal and pelvic floor muscles in preparation for vaginal delivery</title><secondary_protocol_no>CP0001</secondary_protocol_no><nct_id>NCT03973281</nct_id><sponsor_type>Industrial</sponsor_type><age_group>Adult</age_group><treatment_type>Treatment</treatment_type><disease_site>Other</disease_site><PI>Iqbal, Sara</PI><institution>Medstar Washington Hospital Center</institution><management_group>Women&#x92;s &amp; Childrens Research</management_group></protocol><sipVersion>2026.1.0 Build 16</sipVersion><copyright> &lt;a href="https://advarra.com" target="_blank"&gt;&amp;copy; 2026 Advarra, Inc.&lt;/a&gt; </copyright></protocol_summary>