High Risk Postpartum Hemorrhage (PPH) Clinical Trial
Official title:
ROTEM® Obstetric Hemorrhage Pilot Study
| NCT number | NCT04409015 |
| Other study ID # | 2020H0119 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 27, 2020 |
| Est. completion date | March 1, 2022 |
| Verified date | September 2022 |
| Source | Ohio State University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This is a prospective observational study among women at high-risk of postpartum hemorrhage, in their third trimester who are admitted to Labor &Delivery in spontaneous labor, for induction of labor, or for scheduled cesarean section.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | March 1, 2022 |
| Est. primary completion date | January 30, 2021 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: 1. Age = 18 years and able to provide consent 2. Gestational age = 34 weeks 3. = 1 High-risk of postpartum hemorrhage criteria defined as either of: 1. Nulliparous women admitted for induction of labor with unfavorable cervix (Bishop's score <5) 2. Prior uterine surgery (> 1 prior cesarean or myomectomy) 3. Patients undergoing trial of labor after cesarean delivery 4. History of postpartum hemorrhage 5. =4 previous vaginal deliveries 6. Multiple gestation 7. The presence of > 2 uterine fibroids or fibroid > 5 cm on any ultrasound during the pregnancy 8. Planned magnesium sulfate use 9. Placenta previa/accreta/increta/percreta Exclusion Criteria: 1. Receipt of anticoagulation (prophylactic anticoagulation stopped 24 hours prior to sample collection is not an exclusion) 2. Antepartum hemorrhage present on admission (>500cc Estimated Blood Loss (EBL)) 3. Coagulation defects 4. Thrombocytopenia with platelets count <100,000 5. Enrolled in the "Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean (TXA)" (NCT03364491) study or planned receipt of Tranexamic Acid (TXA) prior to enrollment. |
| Country | Name | City | State |
|---|---|---|---|
| United States | The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine | Columbus | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Ohio State University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluating degrees of Fibrin polymerization (FIBTEM) ROTEM in the immediate postpartum period. | After delivery through study completion, an average of 2 years | ||
| Secondary | Evaluating INTEM, EXTEM and APTEM Clotting time in pre and post-delivery. | Pre and post-delivery through study completion, an average of 2 years | ||
| Secondary | Evaluating volume of estimated and quantitative blood loss | Pre and post-delivery through study completion, an average of 2 years | ||
| Secondary | Evaluating change in hemoglobin/hematocrit ratio between values on admission for delivery (or in the last 4 weeks prior to delivery) and at 24 (+/-4) hours postpartum | Pre and post-delivery through study completion, an average of 2 years | ||
| Secondary | Evaluating amount of Postpartum hemorrhage defined as Quantitative Blood Loss >500ml for vaginal delivery and >1000ml for cesarean delivery | Pre and post-delivery through study completion, an average of 2 years | ||
| Secondary | Evaluating frequency of blood transfusion and related morbidities | Pre and post-delivery through study completion, an average of 2 years | ||
| Secondary | Evaluating number of severe maternal morbidity (including admission to ICU, intubation, shock) | Pre and post-delivery through study completion, an average of 2 years | ||
| Secondary | Evaluating incidence of need for surgical and non-surgical interventions to manage Postpartum hemorrhage (PPH) | Pre and post-delivery through study completion, an average of 2 years |