Autopsy report · NCT03172858

Randomized Control Trial of Intracervical Balloon Placement vs Oxytocin in Women With Term PROM and Unripe Cervices

“The IRB identified too many safety issues and the study did not move ahead.”

The sponsor’s own words in the registry.

Life of this trial

• Withdrawn before it enrolled anyone. Its dates are the sponsor's plans, not events that happened.

Vital statistics

Status

Withdrawn

Phase

Na

Sponsor

Northwestern University

Sponsor type

University, hospital or other

Conditions

Premature Rupture of Membrane; Unfavorable Cervix

Interventions

Intracervical balloon catheter; Oxytocin

Participants

0

Sites

1

Countries

United States

Trials that died the same way

• Retroperitoneal Ligation of Uterine Artery in Total Laparoscopic Hysterectomy for Enlarged Uterus
  “IRB did not approve this study.” (73% match in meaning)
• A Quality of Life Study Using Insulin Potentiation Targeted LowDose (IPTLD) Chemotherapy and Nutrition Therapy in the Treatment of Cancer
  “The IRB which was overseeing the study stopped overseeing it” (70% match in meaning)
• Intestinal Microbiome Post-Azythromycin/Albendazole Treatment
  “We were not able to secure IRB approval in the timeline necessary to do this study.” (70% match in meaning)
• Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Kidney Transplant
  “did not move forward with IRB approval, competing study” (69% match in meaning)
• Safety of Topical Tranexamic Acid in Total Joint Arthroplasty in High Risk Patients
  “Study did not receive IRB approval, so did not start” (68% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.