Prophylactic Amnioinfusion for Prevention of Postpartum Hemorrhage

NCT06691945 | Not Yet Recruiting Phase 3 FDA Drug FDA Device

• 1 other identifier: HSC-MS-24-0439
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postpartum Hemorrhage

Outcome Measures

Primary Outcomes (3)

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

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

• Number of participants who have transfusion of any blood products

  from delivery admission to discharge or up to 12 weeks post delivery

• Number of participants who have hysterectomy

  from delivery admission to discharge or up to 12 weeks post delivery

Secondary Outcomes (21)

• Number of mothers who use uterotonics, in addition to oxytocin

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

• Estimated blood loss(mL)

  post delivery (from immediately after delivery to upto 2 hours after delivery)

• Quantitative blood loss(mL)

  post delivery(from immediately after delivery to upto 2 hours after delivery)

• Delta change in hemoglobin of mothers

  pre delivery, post partum day 1

• Number of mothers who have cesarean deliveries

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

Study Arms (2)

Prophylactic amnioinfusion

EXPERIMENTAL

Combination Product: Saline delivered using an intrauterine pressure catheter (IUPC)

Routine Care

NO INTERVENTION

Interventions

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.

Prophylactic amnioinfusion

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

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

Study Officials

• Sarah Mehl, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Mehl, MD

CONTACT

(712) 500-6412; Sarah.Theriot@uth.tmc.edu

Ahmed S Zaki Moustafa

CONTACT

(713) 500-6412; Ahmed.ZakiMoustafa@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 18, 2024
• Study Start: November 11, 2024
• Primary Completion (Estimated): November 11, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)