Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT07199803
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 18 years or older who have delivered at Mount Sinai Hospital.
* Delivery via vaginal or cesarean delivery with neuraxial analgesia or anesthesia
* Ability to communicate in English (to answer OBSQoR-10 survey) PPH Cohort
* Quantitative Blood Loss (QBL) ≥ 1000 mL or,
* Transfusion of blood due to PPH or,
* Transfer to ICU level care due to PPH
* Significant PPH intervention, i.e. hysterectomy or arterial embolization Non-PPH
* QBL \< 500 mL and,
* No transfusion of blood products, and
* No need for elevated care environment, i.e. HAU or ICU
Exclusion Criteria:
* Patients with pre-existing psychiatric disorders affecting recovery assessment.
* Patients who experience severe obstetric complications other than PPH (e.g., eclampsia, uterine rupture).
* Overdistended uterus due to; Polyhydramnios (amniotic fluid index \>24 cm) or multiple gestation
* History of previous PPH (documented with blood loss of \>1000 ml, blood transfusion, use surgical methods such as Bakri balloon, B-Lynch sutures, uterine artery ligation or embolization)
* BMI \> 50
* Language barrier (English)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT07199803
Study Brief:
Protocol Section:
NCT07199803