Clinical Trial Search

Primary: Number of Participants With Need for Additional Uterotonics (Methylergonovine, Carboprost, Misoprostol) — 80; 80 Participants

Primary: Number of Subjects Reporting Uterine Atony or Postpartum Hemorrhage Requiring Medical (Medication or Blood Transfusion), Surgical or Other Interventional Treatment — 45…

Primary: Uterine Tone Score — 4.7; 4.4 score on a scale

Primary: Quantitative Blood Loss — 840; 1051 milliliters — p=<0.05

Primary: Blood Loss — 616; 418; 141; 106 cc

Primary: Uterine Atony — 4; 10 Participants

Primary: PK Model Parameter Estimates — 8.85; 10.39; 9.45 L/hr

Primary: Number of Participants With Excessive Bleeding as Determined by the Composite Outcome Criteria — 78; 75 Participants — p=0.5

Primary: Difference in Actual Blood Volume and Estimated Blood Volume in Milliliters. — -20.8; -41.7; -53.5; -96.0 milliliters — p=<0.05

Primary: Need for Additional Uterotonic Medications — 10; 40 percentage of participants — p=<0.01

Primary: The Primary Outcome is a Composite of the Following Three Clinical Outcomes: 1) Severe PPH Defined as Blood Loss ≥1000 ml or; 2) Postpartum Laparotomy for Bleeding or…

Primary: Fibrinogen Level at 2 Hours After Delivery — 186; 418 mg/dL — p=<0.05

Primary: Surgical Blood Loss — 761; 691 ml

Primary: Time to Bleeding Control After AAJT-S Device Application — 2 Minutes

Primary: Clinical Estimated Blood Loss (EBL) Between Cases and Controls Using Clinical Estimate Versus Device Assessment — 800; 800 milliLiters

Primary: Total Estimated Blood Loss — 512; 634 ml

Primary: Number of Participants With Maternal Death or Transfusion of Packed Red Blood Cells — 201; 233 Participants — p=0.19

Primary: The Amount of Hemorrhage During Cesarean Delivery and Within 2 Hours Afterward — 260; 380 ml

Primary: Failure Rate of PPH Management — 75; 80; 92; 92 Participants — p=0.9563

Primary: Change in Hemoglobin — 1.08; 1.20 mg/dl

Primary: Change in Maternal Hemoglobin Level — 1.1; 2.1 g/dL

Primary: Number of Related SAE — 0 SAEs

Primary: Efficacy: Rate of Participants With Cessation of Uterine Hemorrhaging — 100 Participants

Primary: Total Number of Units Transfused — 1.2; 2.1 units of blood — p=<0.001

Primary: Number of Participants With Postpartum Haemorrhage (PPH) — 48; 54; 56; 71 Participants — p=0.549

Primary: Blood Volume Loss — 2274; 2407 milliliters

Primary: Rate at Which Providers Intervene to Control Blood Loss During D&E Procedures. — 13; 6 Participants

Primary: 1. Amount of Oxytocin to Obtain Satisfactory Uterine Tone. — 8.4; 4.0 IU

Primary: Proportion of Participants With Recorded Blood Pressure Values in Office — 43; 44; 49; 56 Participants

Primary: Endometritis Incidence — 0; 0 participants