30 closest matches · ranked by relevance
Postpartum Hemorrhage · Uterine Atony
Primary: Blood Loss — 616; 418; 141; 106 cc
Myomectomy; Surgical Blood Loss
Primary: Surgical Blood Loss — 761; 691 ml
Hemorrhage
Primary: Number of Participants With Excessive Bleeding as Determined by the Composite Outcome Criteria — 78; 75 Participants — p=0.5
Anemia
Primary: Number of Subjects Achieving 'Clinical Success'. Clinical Success is Defined as an Increase in Hemoglobin of ≥ 2.0 g/dL — 187; 139 participants
Uterine Atony With Hemorrhage
Primary: Number of Participants With Need for Additional Uterotonics (Methylergonovine, Carboprost, Misoprostol) — 80; 80 Participants
Postpartum Hemorrhage · Uterine Atony
Primary: Uterine Tone Score — 4.7; 4.4 score on a scale
Menorrhagia
Primary: Number of Participants With Successful Treatment of Heavy Menstrual Bleeding — 81; 83 Participants
Postpartum Hemorrhage
Primary: Difference in Actual Blood Volume and Estimated Blood Volume in Milliliters. — -20.8; -41.7; -53.5; -96.0 milliliters — p=<0.05
Heavy Menstrual Bleeding
Primary: Hot Flush Frequency Total Score (HFRS) Change — 9.3; 8.8; 12.7 score on a scale
Obstetric Labor Complications · Hemorrhage · Complications; Cesarean Section
Primary: Fibrinogen Level at 2 Hours After Delivery — 186; 418 mg/dL — p=<0.05
Laparoscopic Hysterectomy
Primary: Change in Bleeding at Specified Time Intervals — 485.7; 199.1 seconds
Uterine Atony · Uterine Atony With Hemorrhage · Postpartum Hemorrhage
Primary: Quantitative Blood Loss — 840; 1051 milliliters — p=<0.05
Post-Partum Hemorrhage
Primary: Failure Rate of PPH Management — 75; 80; 92; 92 Participants — p=0.9563
Heavy Menstrual Bleeding · Menorrhagia · Uterine Fibroids
Primary: Change in Self-Reported Menorrhagia Scores — 59.1; 25.4 score on a scale — p=0.11
Pregnancy Complications
Primary: Clinical Estimated Blood Loss (EBL) Between Cases and Controls Using Clinical Estimate Versus Device Assessment — 800; 800 milliLiters
Uterine Myomas
Primary: Co-primary Endpoint: Percentage of Subjects With Reduction in Uterine Bleeding Defined as a Pictorial Blood-loss Assessment Chart (PBAC) Score <75 at End-of-treatment…
Metrorrhagia
Primary: Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms — 0.295; 0.012 Proportion of participants — p=< 0.0001
Dysfunctional Uterine Bleeding
Primary: Cessation of Bleeding Within 5 Days — 48 participants
Anemia
Primary: Evaluate the Safety of the Maximum Administered Dose, 15 mg/kg (up to a Maximum 1,000 mg) of FCM Compared to SMC. — 6; 22 participants
Heavy Uterine Bleeding · Uterine Fibroids
Primary: Percentage of Participants With a Menstrual Blood Loss (MBL) Volume of < 80 mL at the Final Month and a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month…
Metrorrhagia
Primary: Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms — 0.292; 0.029 Proportion of participants — p=< 0.0001
Leiomyoma · Uterine Hemorrhage
Primary: Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 1 — 0.0; 42.0; 54.8 percentage of participants
Leiomyoma · Laparoscopy · Uterine Myomectomy
Primary: Hemoglobin Levels Difference Between Pre and Post Surgery. — 0.76; 0.93 g/dL
Heavy Uterine Bleeding · Uterine Fibroids
Primary: Mean Change From Baseline to the Last 28 Days of Treatment in Menstrual Blood Loss (MBL) — 213.70; 269.36; 321.73; 335.11 mL — p=< 0.001
Leiomyoma
Primary: mg Equivalent Morphine Used Until Discharge From Recovery Room to Control Pain Level Below 4/10 (VAS) — 11; 5.1 mg
Menorrhagia
Primary: The Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to the End-of-study MBL (Cycle 6) — -128.78; -17.7 milliliter (mL) — p=<0.001
Leiomyoma · Uterine Hemorrhage
Primary: Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment — 1.8; 47.2; 58.3 percentage of participants
Uterine Myomas
Primary: Percentage of Subjects With Reduction of Uterine Bleeding at Week 13 Visit Defined as Pictorial Blood-loss Assessment Chart (PBAC) Score < 75 at End-of-treatment Visit…
Uterine Atony · Uterine Atony With Hemorrhage · Cesarean Section Complications
Primary: Uterine Atony — 4; 10 Participants
Post Partum Hemorrhage
Primary: Number of Related SAE — 0 SAEs