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NCT Number: NCT06691945

Prophylactic Amnioinfusion for Prevention of Postpartum Hemorrhage

The purpose of this study is to decrease the likelihood of composite postpartum hemorrhage (PPH) morbidity, which consists of i) Estimated or quantified blood loss of 1,500 mL or more, ii) transfusion of any blood products or iii) hysterectomy

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Key information

Conditions

Postpartum Hemorrhage Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Singletons with a gestational age of 34.0 weeks or more
  • Labor (spontaneous or medical induction)
  • Medium- or High-risk for PPH, as described by American College of Obstetricians and Gynecologists (ACOG)

Exclusion criteria

  • Scheduled cesarean delivery
  • Multiple gestations
  • Delivery at < 34.0 weeks
  • Contraindication to place intrauterine pressure catheter (e.g. HIV)
  • Incarcerated subjects
  • Major fetal anomalies requiring neonatal surgical intervention
  • Stillbirth on admission

Treatment and study plan

Saline delivered using an intrauterine pressure catheter (IUPC)

Combination Product

An intrauterine pressure catheter (IUPC) will be placed in participants after membrane rupture, or at 4 cm if membranes previously ruptured. A 300cc bolus of normal saline will be administered. A continuous rate of 100 cc/hr of normal saline will continue until delivery to prevent Postpartum Hemorrhage. If the IUPC is dislodged, it will be replaced by a trained clinician.

Primary outcomes

  1. Number of participants who have estimated or quantified blood loss of 1,500 mL or more

    Time frame: from delivery admission to discharge (average of 3 days post delivery)

  2. Number of participants who have transfusion of any blood products

    Time frame: from delivery admission to discharge or up to 12 weeks post delivery

  3. Number of participants who have hysterectomy

    Time frame: from delivery admission to discharge or up to 12 weeks post delivery

Secondary outcomes

  1. Number of mothers who use uterotonics, in addition to oxytocin

    Time frame: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period

  2. Estimated blood loss(mL)

    Time frame: post delivery (from immediately after delivery to upto 2 hours after delivery)

  3. Quantitative blood loss(mL)

    Time frame: post delivery(from immediately after delivery to upto 2 hours after delivery)

  4. Delta change in hemoglobin of mothers

    Time frame: pre delivery, post partum day 1

  5. Number of mothers who have cesarean deliveries

    Time frame: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period

  6. Number of mothers who need Mechanical tamponade

    Time frame: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period

  7. Number of mothers who have surgical interventions (O'Leary, B 'Lynch or uterine arterial embolization)

    Time frame: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period

  8. Number of mothers who have Chorioamnionitis

    Time frame: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period

  9. Number of mothers who have endometritis

    Time frame: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period

  10. Number of mothers who have wound complications (if cesarean delivery)

    Time frame: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period

  11. Number of mothers who are admitted to intensive care unit

    Time frame: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period

  12. Number of deaths

    Time frame: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period

  13. Number of neonates with Apgar < 7

    Time frame: at 5 minutes after delivery

  14. Number of neonates that have a seizure

    Time frame: delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications

  15. Number of neonates that have meconium aspiration syndrome

    Time frame: delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications

  16. Number of neonates that have Ventilation > 6 hrs

    Time frame: delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications

  17. Number of neonates that have Bronchopulmonary dysplasia

    Time frame: delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications

  18. Number of neonates that have Necrotizing enterocolitis

    Time frame: delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications

  19. Number of neonates that have Sepsis

    Time frame: delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications

  20. Number of stillbirths

    Time frame: at delivery

  21. Number of deaths of neonates

    Time frame: within 27 days of birth

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed S Zaki Moustafa

CONTACT

[email protected]

(713) 500-6412

Sarah Mehl, MD

CONTACT

[email protected]

(712) 500-6412

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

Prophylactic Amnioinfusion for Prevention of Postpartum Hemorrhage: A Randomized Clinical Trial (PURPOSE)

Acronym: PURPOSE

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Nov 18, 2024
Registry last updated
Nov 18, 2024

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.

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