[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07717502":3,"trial-entities:NCT07717502":98,"trial-summary:NCT07717502":101},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":43,"secondary_outcomes":47,"sex":48,"minimum_age":49,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":50,"std_ages":67,"locations":70,"central_contacts":88,"overall_officials":95,"references":96,"see_also_links":97},"NCT07717502","2025.432","Ripening Approaches for Prompt Induction and Delivery - Sequential Versus Concurrent Dilapan-S and Misoprostol to Achieve Vaginal Delivery (RAPID-DS)","NOT_YET_RECRUITING","2027-12","2026-07","2026-07-21","2026-08","Ochsner Health System","OTHER",false,"The purpose of this study is to compare the effectiveness of sequential versus combined multimodal cervical ripening strategies to achieve vaginal delivery within 24 hours among nulliparous patients with singleton, vertex pregnancies at term undergoing induction of labor.",null,[18,19],"Nulliparous Women Who Scheduled for Labor Induction","Pregnancy",[21,22,23,24],"nulliparous","labor induction","cervical ripening","misoprostol","INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[28],"NA",{"count":30,"type":31},260,"ESTIMATED",[33,39],{"type":34,"name":35,"description":36,"armGroupLabels":37},"COMBINATION_PRODUCT","Sequential Cervical Ripening","Those assigned to sequential cervical ripening will be scheduled with a trained physician for placement of Dilapan-STM osmotic cervical dilators in the outpatient setting at 12 to 24 hours prior to their scheduled labor and delivery admission. Upon admission to labor and delivery, sequential patients will have Dilapan-S removed during clinical vaginal exam and will receive misoprostol 25 mcg every two hours up to 8 doses until modified Bishop score is greater than 4, warranting transition to oxytocin infusion.",[38],"Outpatient Sequential Cervical Ripening",{"type":34,"name":40,"description":41,"armGroupLabels":42},"Inpatient Combined Cervical Ripening","Those randomized to scheduled induction of labor in the inpatient setting will present as scheduled to labor unit, at which time they will undergo clinical assessment and will receive placement of Dilapan-S by a trained physician along with misoprostol 25 mcg every 2 hours up to 8 doses or until clinical exam demonstrates modified Bishop score greater than 4, warranting transition to oxytocin infusion.",[40],[44],{"measure":45,"timeFrame":46},"vaginal delivery within 24 hours of hospital admission","Admission to 24 hours",[],"FEMALE","18 Years",{"inclusion":51,"exclusion":53,"raw_text":66},[52],"Nulliparous patients with singleton pregnancies with vertex lie at term receiving prenatal care that are eligible for outpatient cervical ripening will be eligible",[54,55,56,57,58,59,60,61,62,63,64,65],"age less than 18,","suspected major fetal anomalies (including suspected or proven chromosome anomalies, congenital cardiac disease expected to require neonatal intervention, and multiple anomalies suggestive of a complex syndrome),","fetal growth restriction","oligohydramnios","prior full thickness","uterine scar","placenta previa,","low-lying placenta,","premature rupture of amniotic membranes,","cervical dilation \\> 2 cm","modified Bishop score \\> 4","residence greater than 60 minutes from the hospital","Inclusion Criteria:\n\n* Nulliparous patients with singleton pregnancies with vertex lie at term receiving prenatal care that are eligible for outpatient cervical ripening will be eligible\n\nExclusion Criteria:\n\n* age less than 18,\n* suspected major fetal anomalies (including suspected or proven chromosome anomalies, congenital cardiac disease expected to require neonatal intervention, and multiple anomalies suggestive of a complex syndrome),\n* fetal growth restriction\n* oligohydramnios\n* prior full thickness\n* uterine scar\n* placenta previa,\n* low-lying placenta,\n* premature rupture of amniotic membranes,\n* cervical dilation \\> 2 cm\n* modified Bishop score \\> 4\n* residence greater than 60 minutes from the hospital",[68,69],"ADULT","OLDER_ADULT",[71],{"facility":72,"city":73,"state":74,"zip":75,"country":76,"contacts":77,"geoPoint":85},"Ochsner Baptist","New Orleans","Louisiana","70115","United States",[78,83],{"name":79,"role":80,"phone":81,"email":82},"Frank Williams, MD","CONTACT","504-899-9311","frank.williams2@ochsner.org",{"name":79,"role":84},"PRINCIPAL_INVESTIGATOR",{"lat":86,"lon":87},29.95465,-90.07507,[89,91],{"name":79,"role":80,"phone":90,"email":82},"205-994-4820",{"name":92,"role":80,"phone":93,"email":94},"Ken Bode","504-842-1936","ken.bode@ochsner.org",[],[],[],{"nct_id":4,"conditions":99,"biomarkers":100},[19],[],{"nct_id":4,"found":102,"summary":103,"prompt_version":113},true,{"design":104,"status":105,"heading":106,"summary":107,"follow_up":108,"word_count":109,"commitments":110,"compensation":111,"drugs_mentioned":112},"This is an interventional study comparing two different methods for cervical ripening. It plans to enroll 260 participants.","completed","Ripening Approaches for Prompt Induction and Delivery (RAPID-DS) Study","This study is looking at the best way to prepare the cervix (the lower part of the uterus) for labor induction in women who are pregnant for the first time. It compares two methods: one where Dilapan-S (a device that helps open the cervix) is placed 12-24 hours before you come to the hospital, and another where Dilapan-S is placed at the hospital along with misoprostol (a medication that helps ripen the cervix). The study wants to see which approach helps achieve a vaginal delivery within 24 hours of being admitted to the hospital. You might be able to join if you are at least 18 years old, pregnant with one baby, and planning to have your labor induced. The study is currently recruiting 260 participants.","The primary outcome is measured within 24 hours of hospital admission.",126,"You would either have Dilapan-S placed in an outpatient setting 12-24 hours before hospital admission, or have Dilapan-S placed and receive misoprostol at the hospital.","Not stated in the trial record.",[],"v2"]