Amnioinfusion for Postpartum Hemorrhage

(PURPOSE Trial)

Recruiting in Houston (>99 mi)

Overseen By Ahmed S Zaki Moustafa

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Scheduled cesarean, Multiple gestations, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: During labor

700 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is amnioinfusion generally safe for humans?

Amnioinfusion is generally considered safe with few adverse effects, as studies have shown no complications related to the procedure and it is described as a simple and safe treatment. ^{1 2 3 4 5}

How does the treatment Prophylactic Amnioinfusion for Postpartum Hemorrhage differ from other treatments?

Prophylactic Amnioinfusion is unique because it involves introducing fluid into the uterus during labor to manage complications like meconium (a newborn's first stool) and low amniotic fluid levels, which can help reduce fetal distress and improve outcomes. This method is considered safe and effective, with fewer adverse effects compared to other treatments. ^{1 3 6 7 8}

What data supports the effectiveness of the treatment Prophylactic Amnioinfusion for Postpartum Hemorrhage?

Research on prophylactic amnioinfusion in women with low amniotic fluid during labor shows it can reduce the need for cesarean sections and other interventions, suggesting it helps improve outcomes during childbirth. This indicates that amnioinfusion may be beneficial in managing complications, although its direct effectiveness for postpartum hemorrhage is not specifically studied. ^{6 7 9 10 11}

Who Is on the Research Team?

Sarah Mehl, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for individuals at risk of postpartum hemorrhage (PPH) after giving birth. Specific eligibility criteria are not provided, but typically participants would be pregnant women nearing delivery who meet the study's health requirements.

Inclusion Criteria

Labor (spontaneous or medical induction)

Medium- or High-risk for PPH, as described by American College of Obstetricians and Gynecologists (ACOG)

I am pregnant with one baby who is at least 34 weeks along.

Exclusion Criteria

I am scheduled for a cesarean delivery.

Multiple gestations

Contraindication to place intrauterine pressure catheter (e.g. HIV)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive prophylactic amnioinfusion to prevent postpartum hemorrhage

During labor

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on postpartum hemorrhage outcomes

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Prophylactic Amnioinfusion

Trial Overview The trial is testing if a saline solution delivered through an intrauterine pressure catheter can prevent severe PPH, which includes heavy blood loss (1,500 mL or more), the need for blood transfusions, or hysterectomy.

How Is the Trial Designed?

Group I: Prophylactic amnioinfusion Experimental Treatment 1 Intervention

Group II: Routine Care Active Control 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Published Research Related to This Trial

In a study of 305 patients with oligohydramnios, prophylactic amnioinfusion significantly reduced the need for operative interventions due to fetal distress and lowered the cesarean section rate, indicating its efficacy in improving labor outcomes.

Patients who received amnioinfusion also had higher umbilical artery pH levels at delivery and shorter hospital stays, suggesting that this intervention can enhance fetal well-being without increasing the risk of complications like amnionitis or endometritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prophylactic amnioinfusion as a treatment for oligohydramnios in laboring patients: a prospective, randomized trial. Schrimmer, DB., Macri, CJ., Paul, RH.[2019]

Two cases of fatal amniotic fluid embolism occurred in women who underwent saline amnioinfusion during labor, particularly after thick meconium staining was observed, raising concerns about the safety of this intervention in such situations.

While amniotic fluid embolism is rare, the cases suggest a potential link between amnioinfusion and increased risk, especially in the presence of rapid labor and meconium-stained fluid, warranting further investigation without immediate changes to clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amniotic fluid embolism after saline amnioinfusion: two cases and review of the literature. Maher, JE., Wenstrom, KD., Hauth, JC., et al.[2015]

A survey of 78 academic obstetrics and gynecology departments in the U.S. revealed that amnioinfusion is performed with a variety of protocols and is associated with few complications, indicating its relative safety.

The study found no significant relationship between the method of amnioinfusion or the number of procedures performed and the incidence of complications, suggesting that amnioinfusion can be safely implemented across different practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amnioinfusion survey: prevalence, protocols, and complications. Wenstrom, K., Andrews, WW., Maher, JE.[2019]

In a study of 313 transabdominal amnioinfusion procedures involving 126 patients, no maternal deaths occurred, indicating a high level of safety for the procedure.

While there were some adverse events, including seven severe fetal complications, the overall low incidence of serious maternal or fetal adverse events suggests that amnioinfusion can be performed with minimal risk, encouraging its use in challenging cases of oligohydramnios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transabdominal amnioinfusion: An evaluation of its adverse events. Nagai, R., Takahashi, Y., Iwagaki, S., et al.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Prophylactic transcervical amnioinfusion in laboring women with oligohydramnios. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Prophylactic amnioinfusion as a treatment for oligohydramnios in laboring patients: a prospective, randomized trial. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Prophylactic amnioinfusion for intrapartum oligohydramnios: a meta-analysis of randomized controlled trials. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Prophylactic intrapartum amnioinfusion: a randomized clinical trial. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Amnioinfusion Compared With No Intervention in Women With Second-Trimester Rupture of Membranes: A Randomized Controlled Trial. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Amniotic fluid embolism after saline amnioinfusion: two cases and review of the literature. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Amnioinfusion survey: prevalence, protocols, and complications. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Prophylactic amnioinfusion during labor complicated by meconium: a preliminary report. [2019]

9. Ireland pubmed.ncbi.nlm.nih.gov

Transabdominal amnioinfusion: An evaluation of its adverse events. [2022]

10. Australia pubmed.ncbi.nlm.nih.gov

A controlled trial of amnioinfusion: the prevention of meconium aspiration in labour. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Transcervical amnioinfusion. [2005]