Postpartum Hemorrhage Prevention in Patients With Preeclampsia (PHP3 Study)

NCT02221830 | Completed Early Phase 1

• 2 other identifiers: 13-2738UL1TR001082
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of the efficacy of postpartum 24 hour oxytocin infusion to reduce blood loss in patients with pre-eclampsia (PE)

Conditions

Preeclampsia

Outcome Measures

Primary Outcomes (1)

• Evaluation of Postpartum hematocrit

  Postpartum hematocrit (collected 24 hours after delivery unless patient receives blood transfusion, then pre-transfusion hematocrit will be used)

  24 hours postpartum

Secondary Outcomes (3)

• Primary postpartum hemorrhage

  Before discharge from hospital

• Estimated blood loss at delivery

  Before discharge from hospital

• Postpartum blood loss

  24 hours postpartum

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Normal Saline (standard of care)

Drug: Placebo

Treatment

EXPERIMENTAL

normal saline + oxytocin

Drug: Oxytocin

Interventions

Oxytocin DRUG

Our intervention simply replaces the standardly given normal saline with treatment (normal saline + oxytocin)

Treatment

Placebo DRUG

This intervention utilizes a Placebo Camparator

Placebo

Eligibility Criteria

• Age: 13 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• vaginal or cesarean delivery at a gestational age greater than or equal to 20 weeks gestational age;
• diagnosis of preeclampsia (PE defined using standard definitions based on the ACOG bulletin and the NIH Working Group on High Blood Pressure in Pregnancy (i.e., a systolic blood pressure greater than 140 mm Hg or a diastolic blood pressure greater than 90 mm Hg on at least 2 occasions at least 6 hours apart after 20 weeks gestation and proteinuria of \> 300mg per 24 hour period or \> 1+ on dipstick).
• patients treated with magnesium sulfate for 24 hours post partum at 2g/hr (standard of care when deemed appropriate by clinician for seizure prophylaxis)

You may not qualify if:

• abnormal placentation (previa, accreta, etc)
• antenatal hemorrhage
• contraindication to oxytocin

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Clinical and Translational Research Center

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Amy Hermesch, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2014
• First Posted: August 20, 2014
• Study Start: February 1, 2015
• Primary Completion: July 17, 2019
• Study Completion: July 17, 2019
• Last Updated: May 7, 2021

Record last verified: 2021-05

Locations

US (1)