Brooklyn, NYNCT06646653Now EnrollingIRB Ready

Postpartum Haemorrhage (PPH) Clinical Trial in Brooklyn, NY

Access cutting-edge postpartum haemorrhage (pph) treatment through this clinical trial at a research site in Brooklyn. Study-provided care at no cost to qualified participants.

Sponsored by ResQ Medical Ltd

Quick Self-Assessment

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Expert Care in Brooklyn

Access postpartum haemorrhage (pph) specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related postpartum haemorrhage (pph) treatment provided free

Apply for This Brooklyn Location

Check if you qualify for this postpartum haemorrhage (pph) clinical trial in Brooklyn, NY

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Brooklyn

    Convenient for NY residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Brooklyn site if eligible
  4. 4Begin participation

About This Postpartum Haemorrhage (PPH) Study in Brooklyn

abnormal bleeding after childbirth. This condition is called abnormal bleeding and becomes a condition known as postpartum hemorrhage (PPH) when worsens. Abnormal bleeding is defined as the loss of more than 500 milliliters (about two cups) of blood after a vaginal birth, or more than 1,000 milliliters (about four cups) after a cesarean section. It is a serious and potentially life-threatening complication that requires immediate medical treatment. What you need to know: * Signing this form does not mean you will have an emergency postpartum bleeding. * We will only include you in the study IF abnormal bleeding happens after your birth. * If abnormal bleeding does happen, your doctors will first try the usual treatments that work in accordance with the hospital's PPH protocol. * The study device (called Alma system) would only be used if the usual treatments do not stop the bleeding. Treatment Schedule - Recruitment \& Consenting * Screening and enrolment. * Treatment of PPH with Alma system. * Alma Survey * Follow up examination post treatment procedure (after removal of Alma system and before subject discharge from the hospital). * 6-week postpartum follow-up examination.

Sponsor: ResQ Medical Ltd

Who Can Participate

Inclusion Criteria

Adult Female, 18 years of age or older at time of consent.
Able to understand and provide informed consent to participate in the study.
Diagnosis of abnormal postpartum uterine bleeding or hemorrhage with suspected atony within 24 hours after vaginal or c-section delivery.
EBL, determined when investigator is ready to have the Alma peel pack opened: Vaginal delivery: 500 - 1500 ml EBL or C-section delivery 1000 - 1500 ml EBL
Failed first-line intervention of uterotonics and uterine massage/bimanual uterine massage to stop bleeding. Note: Uterotonic administration may continue concomitantly with and post Alma use, as long as such use does not exceed the maximum dose of the drug 10.3.2 Exclusion Criteria
EBL \>1500ml, to be determined when investigator is ready to have the Alma peel pack opened.
Delivery at a gestational age \< 34 weeks.
For Cesarean-sections birth: Cervix \< 3 cm dilated before use of Alma.
PPH that the investigator determines to require more aggressive treatment, including any of the following:
hysterectomy;
b-lynch suture;
uterine artery embolization or ligation;
hypogastric ligation.
Known uterine anomaly.
Ongoing intrauterine pregnancy.
Placenta abnormality including any of the following:
known placenta accreta;
retained placenta with known risk factors for placenta accreta (e.g. history of prior uterine surgery, including prior c-section and placenta previa);
retained placenta without easy manual removal.
Known uterine rupture.
Unresolved uterine inversion.
Subject has undergone intrauterine balloon therapy or uterine packing or use of other negative pressure system(s) for tamponade treatment of this PPH prior to use of Alma.
Current cervical cancer.
Current purulent infection of vagina, cervix, uterus.
Diagnosis of coagulopathy.

Exclusion Criteria

EBL \>1500ml, to be determined when investigator is ready to have the Alma peel pack opened.
Delivery at a gestational age \< 34 weeks.
For Cesarean-sections birth: Cervix \< 3 cm dilated before use of Alma.
PPH that the investigator determines to require more aggressive treatment, including any of the following:
hysterectomy;
b-lynch suture;
uterine artery embolization or ligation;
hypogastric ligation.
Known uterine anomaly.
Ongoing intrauterine pregnancy.
Placenta abnormality including any of the following:
known placenta accreta;
retained placenta with known risk factors for placenta accreta (e.g. history of prior uterine surgery, including prior c-section and placenta previa);
retained placenta without easy manual removal.
Known uterine rupture.
Unresolved uterine inversion.
Subject has undergone intrauterine balloon therapy or uterine packing or use of other negative pressure system(s) for tamponade treatment of this PPH prior to use of Alma.
Current cervical cancer.
Current purulent infection of vagina, cervix, uterus.
Diagnosis of coagulopathy.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Brooklyn?

Yes, this clinical trial (NCT06646653) has an active research site in Brooklyn, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Postpartum Haemorrhage (PPH) Treatment Options in Brooklyn, NY

If you're searching for postpartum haemorrhage (pph) treatment options in Brooklyn, NY, this clinical trial (NCT06646653) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Brooklyn research site is actively enrolling participants for this clinical trial. You'll receive care from experienced postpartum haemorrhage (pph) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all postpartum haemorrhage (pph) clinical trials near you to find additional studies recruiting in your area.

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