Amnioinfusion for Postpartum Hemorrhage

(PURPOSE Trial)

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of prophylactic amnioinfusion—a procedure introducing fluid into the amniotic sac—in reducing severe bleeding after childbirth (postpartum hemorrhage). Researchers aim to determine if this treatment can decrease the need for blood transfusions or surgeries such as hysterectomies. Participants should be expecting a single baby, be at least 34 weeks pregnant, and have a medium or high risk of heavy bleeding after delivery. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

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 there any evidence suggesting that prophylactic amnioinfusion is likely to be safe for humans?

Research has shown that preventive amnioinfusion is generally safe. Studies have found that the procedure has few side effects, and no complications related to it have been reported. Patients usually tolerate it well. The treatment involves introducing sterile fluid into the uterus to help prevent heavy bleeding after childbirth. Overall, safety data from past studies suggest that preventive amnioinfusion is a safe option for managing this type of bleeding. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the use of prophylactic amnioinfusion for postpartum hemorrhage because it introduces a novel method for managing this condition. Unlike traditional treatments, which often include medications like oxytocin or surgical interventions to control bleeding, amnioinfusion involves infusing a sterile solution into the uterus to help reduce bleeding by maintaining uterine tone and volume. This technique could potentially offer a less invasive alternative with fewer side effects, providing immediate support in stopping excessive bleeding after childbirth. By exploring this innovative approach, researchers hope to enhance safety and outcomes for new mothers experiencing postpartum hemorrhage.

What evidence suggests that prophylactic amnioinfusion might be an effective treatment for postpartum hemorrhage?

Research has shown that a preventive treatment called amnioinfusion might help stop heavy bleeding after childbirth, known as postpartum hemorrhage (PPH). In this trial, some participants will receive prophylactic amnioinfusion, which previous studies have shown reduces blood loss after delivery, an important factor in managing PPH. One study found that patients with low levels of amniotic fluid who received amnioinfusion needed fewer emergency procedures for baby distress. These results suggest that amnioinfusion could lower the risk of severe bleeding after childbirth. While more research is needed, these early findings are promising for those considering this treatment. ^{1 2 6 7 8}

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

Multiple gestations

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

Incarcerated subjects

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]

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]

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]

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. clinicaltrials.gov clinicaltrials.gov/study/NCT06691945

Prophylactic Amnioinfusion for Prevention of Postpartum ... 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 ...

2. withpower.com withpower.com/trial/phase-3-postpartum-hemorrhage-10-2024-33844

Amnioinfusion for Postpartum Hemorrhage (PURPOSE Trial) In a study of 305 patients with oligohydramnios, prophylactic amnioinfusion significantly reduced the need for operative interventions due to fetal distress ...

3. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1002/ijgo.70636?af=R

Comparative evaluation of prophylactic strategies for ... Results from the present study confirm that IV oxytocin administration is more effective in preventing PPH after vaginal delivery when compared ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9941009/

Postpartum hemorrhage protocols and benchmarks Stage-based hemorrhage protocols are designed to reduce delays in the diagnosis and management and avoid the pitfalls of cognitive biases.

5. researchgate.net researchgate.net/publication/388863976_The_Yield_of_Amnioinfusion_in_the_Prevention_of_Postpartum_Hemorrhage

The Yield of Amnioinfusion in the Prevention of Postpartum ... Primary outcomes were QBL at delivery and total postpartum blood loss (PPBL). Secondary outcomes were PPH rate (≥ 1000 mL) and a composite of maternal morbidity ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39929244/

The Yield of Amnioinfusion in the Prevention of Postpartum ... Out of 113,816 deliveries during the study period, 83,152 (77.1%) met inclusion criteria, and among them 4,597 (4.03%) had amnioinfusion.

7. ajog.org ajog.org/article/S0002-9378(22)02204-9/fulltext

Third stage of labor: evidence-based practice for ... The authors also found notable consequences of active management, including an increase in postpartum blood pressure, vomiting, pain, return to ...

8. clinicaltrial.be clinicaltrial.be/en/details/459237?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Prophylactic Amnioinfusion for Prevention of Postpartum H... The purpose of this study is to decrease the likelihood of composite postpartum hemorrhage (PPH) morbidity, which consists of i) Estimated ...