Trial · NCT03364491
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Maternal Death or Transfusion of Packed Red Blood Cells | by hospital discharge or by 7 days postpartum, whichever is sooner | Participants were monitored from delivery until hospital discharge or 7 days after delivery (postpartum), whichever is sooner. This is the number of mothers who died for any reason, or had a blood transfusion of 1 or more units (of packed red blood cells, including whole blood or cell saver). |
| Secondary | Number of Participants With Estimated Blood Loss Greater Than 1 Liter During Delivery | From skin incision to transfer from operating room, average of 1 hour | \[Major secondary outcome\] The surgeon or anesthesiologist estimated the blood loss during the delivery in milliliters, which was recorded in the anesthesia record and/or operative report |
| Secondary | Number of Mothers Who Died or Had Thromboembolic Events (Venous or Arterial), Ischemic Stroke, Myocardial Infarction, New-onset Seizure Activity, or Were Admitted to the Intensive Care Unit for More Than 24 Hours | within 6 weeks postpartum | |
| Secondary | Number of Participants Who Were Transfused With Other Blood Products | within 7 days postpartum | This is the number of mothers who received during the first 7 days after delivery a transfusion of 1 or more units of fresh frozen plasma, cryoprecipitate, or platelets, or received any factor concentrates |
| Secondary | Number of Participants Who Were Transfused With 4 or More Units of Packed Red Blood Cells | within 7 days postpartum | Participants were categorized according to the amount of packed red blood cells or whole blood transfused, either as 0 to 3 units, or 4 or more units |
| Secondary | Number of Participants With a Thromboembolic Event (Venous or Arterial), Ischemic Stroke, or Myocardial Infarction | within 6 weeks postpartum | \[Key secondary outcome\] This is the number of mothers who experienced a thromboembolic event, ischemic stroke, or myocardial infarction during the 6 weeks after delivery. |
| Secondary | Number of Participants With Seizure Activity That Was Not Seen Prior to Study Enrollment | within 6 weeks postpartum | This is the number of mothers who experienced seizure activity, confirmed by central review, whose onset is after enrollment |
| Secondary | Number of Participants With Postpartum Infectious Complications | within 6 weeks postpartum | \[Key Secondary Outcome\] This is the number of mothers who experienced any of the following infectious complications in the 6 weeks after delivery: endometritis, surgical site infection, pelvic abscess |
| Secondary | Number of Participants Who Were Treated With Uterotonics Other Than Oxytocin | within 48 hours postpartum | This is the number of mothers who were treated with uterotonics such as prostaglandins or methergine, but excluding oxytocin, from delivery through 48 hours after delivery. |
| Secondary | Number of Participants Who Received Surgical or Radiologic Interventions to Control Bleeding and Related Complications | within 7 days postpartum | This is the number of mothers who required any of the following types of surgical procedures to control bleeding: laparotomy, evacuation of hematoma, hysterectomy, uterine packing, intrauterine balloon tamponade, interventional radiology |
| Secondary | Change in Hemoglobin | from 4 weeks before delivery to 48 hours postpartum | \[Key secondary outcome\] Change in hemoglobin from the most recent measured before delivery to lowest measured in the 48 hours after delivery |
| Secondary | Number of Participants Who Received Open Label TXA or Other Antifibrinolytic | within 7 days postpartum | This is the number of mothers who were treated with any amount of open-label TXA (not blinded study drug) or another antifibrinolytic (eg., Amicar) |
| Secondary | Length of Stay | Until hospital discharge, an average of 3 days | Mother's length of stay from delivery to discharge |
| Secondary | Number of Participants Who Received Treatments and Interventions in Response to Bleeding and Related Complications | within 7 days postpartum | \[Key secondary outcome\] This is the number of mothers who received treatments and interventions to control bleeding such as: uterotonics such as prostaglandins or methergine, but excluding oxytocin; open label TXA or other antifibrinolytics; transfusion of 1 or more units of fresh frozen plasma, cryoprecipitate, or platelets or administration of any factor concentrates; laparotomy, evacuation of hematoma, hysterectomy, uterine packing, intrauterine balloon tamponade, interventional radiology |
| Other | Number of Participants With Maternal Death or Transfusion of Packed Red Blood Cells by Race/Ethnicity | by hospital discharge or by 7 days postpartum, whichever is sooner | NIH-required analysis. Participants were monitored from delivery until hospital discharge or 7 days after delivery (postpartum), whichever is sooner. This is the number of mothers who died for any reason, or had a blood transfusion of 1 or more units (of packed red blood cells, including whole blood or cell saver). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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