Prophylactic Amnioinfusion for Prevention of Postpartum Hemorrhage (PURPOSE)

November 13, 2024 updated by: Sarah Mehl, The University of Texas Health Science Center, Houston

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
700

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Routine Care
Experimental: Prophylactic amnioinfusion
Combination product: Saline delivered using an intrauterine pressure catheter (IUPC)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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)
from delivery admission to discharge (average of 3 days post delivery)
Number of participants who have transfusion of any blood products
Time Frame: from delivery admission to discharge or up to 12 weeks post delivery
from delivery admission to discharge or up to 12 weeks post delivery
Number of participants who have hysterectomy
Time Frame: from delivery admission to discharge or up to 12 weeks post delivery
from delivery admission to discharge or up to 12 weeks post delivery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
Estimated blood loss(mL)
Time Frame: post delivery (from immediately after delivery to upto 2 hours after delivery)
post delivery (from immediately after delivery to upto 2 hours after delivery)
Quantitative blood loss(mL)
Time Frame: post delivery(from immediately after delivery to upto 2 hours after delivery)
post delivery(from immediately after delivery to upto 2 hours after delivery)
Delta change in hemoglobin of mothers
Time Frame: pre delivery, post partum day 1
pre delivery, post partum day 1
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
from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
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
from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
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
from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
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
from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
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
from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
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
from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
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
from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
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
from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
Number of neonates with Apgar < 7
Time Frame: at 5 minutes after delivery
at 5 minutes after delivery
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
delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications
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
delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications
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
delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications
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
delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications
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
delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications
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
delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications
Number of stillbirths
Time Frame: at delivery
at delivery
Number of deaths of neonates
Time Frame: within 27 days of birth
within 27 days of birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center, Houston

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sarah Mehl, MD, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 11, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 11, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSC-MS-24-0439

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings