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Completed

NCT Number: NCT04409015

ROTEM® Obstetric Hemorrhage Pilot Study

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.

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Key information

Conditions

High Risk Postpartum Hemorrhage (PPH)

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

Columbus, Ohio, 43210, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years and able to provide consent
  • Gestational age ≥ 34 weeks
  • ≥ 1 High-risk of postpartum hemorrhage criteria defined as either of:
  • Nulliparous women admitted for induction of labor with unfavorable cervix (Bishop's score <5)
  • Prior uterine surgery (> 1 prior cesarean or myomectomy)
  • Patients undergoing trial of labor after cesarean delivery
  • History of postpartum hemorrhage
  • ≥4 previous vaginal deliveries
  • Multiple gestation
  • The presence of > 2 uterine fibroids or fibroid > 5 cm on any ultrasound during the pregnancy
  • Planned magnesium sulfate use
  • Placenta previa/accreta/increta/percreta

Exclusion criteria

  • Receipt of anticoagulation (prophylactic anticoagulation stopped 24 hours prior to sample collection is not an exclusion)
  • Antepartum hemorrhage present on admission (>500cc Estimated Blood Loss (EBL))
  • Coagulation defects
  • Thrombocytopenia with platelets count <100,000
  • 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.

Treatment and study plan

ROTEM - rotation thromboelastometry testing

Device

The ROTEM® is a simple blood test that provides information about specific components involved in blood clotting and stopping hemorrhage.

Primary outcomes

  1. Evaluating degrees of Fibrin polymerization (FIBTEM) ROTEM in the immediate postpartum period.

    Time frame: After delivery through study completion, an average of 2 years

Secondary outcomes

  1. Evaluating INTEM, EXTEM and APTEM Clotting time in pre and post-delivery.

    Time frame: Pre and post-delivery through study completion, an average of 2 years

  2. Evaluating volume of estimated and quantitative blood loss

    Time frame: Pre and post-delivery through study completion, an average of 2 years

  3. 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

    Time frame: Pre and post-delivery through study completion, an average of 2 years

  4. Evaluating amount of Postpartum hemorrhage defined as Quantitative Blood Loss >500ml for vaginal delivery and >1000ml for cesarean delivery

    Time frame: Pre and post-delivery through study completion, an average of 2 years

  5. Evaluating frequency of blood transfusion and related morbidities

    Time frame: Pre and post-delivery through study completion, an average of 2 years

  6. Evaluating number of severe maternal morbidity (including admission to ICU, intubation, shock)

    Time frame: Pre and post-delivery through study completion, an average of 2 years

  7. Evaluating incidence of need for surgical and non-surgical interventions to manage Postpartum hemorrhage (PPH)

    Time frame: Pre and post-delivery through study completion, an average of 2 years

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jun 1, 2020
Registry last updated
Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.