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Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage (NOVIC)

Primary Purpose

Postpartum Hemorrhage, Maternal Death

Status
Not yet recruiting
Phase
Not Applicable
Locations
Ghana
Study Type
Interventional
Intervention
Jada® System
Standard care
Sponsored by
Women and Infants Hospital of Rhode Island
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Hemorrhage

Eligibility Criteria

18 Years - 44 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years or older
  • Delivery at 34 weeks or greater
  • Cumulative blood loss >1000ml within 24 hours after delivery
  • Uterine atony
  • Receipt of first-line uterotonics
  • Cervix at least 3cm dilated at cesarean section

Exclusion Criteria:

  • Patient unwilling or unable to provide informed consent
  • Retained placenta or other known cause of postpartum hemorrhage
  • Placenta accreta spectrum
  • Coagulopathy
  • Rupture uterus
  • Surgical management immediately needed for life-threatening bleeding
  • Known contraindication for Jada System; ongoing intrauterin pregnancy, untreated uterine rupture, unresolved uterine inversion, current cervical cancer, unknown uterine anomoly, current purulent infection

Sites / Locations

  • Komfo Anokye Teaching Hospital
  • Korle-bu Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Jada® System

Standard care

Arm Description

Patients in this group will have the Jada® System applied when the initial medical treatment fails, and estimated blood loss reaches 1000 mL. It is a U.S. FDA-cleared device intended for treatment of PPH when conservative management is warranted.

Patients in this group will receive care according to the treatment algorithm for PPH from uterine atony at the two teaching hospitals in Ghana. Possible interventions include additional uterotonics, tranexamic acid, and condom catheter balloon uterine tamponade. If bleeding is uncontrolled, patients will have surgical intervention with options of uterine vascular ligation, uterine compression sutures or hysterectomy

Outcomes

Primary Outcome Measures

Maternal survival without surgical intervention
No maternal death postpartum up to 6 weeks and no use of surgical interventions

Secondary Outcome Measures

Time from randomization to control of bleeding
Time from use of first line treatment to control of bleeding
Concentration of postpartum hemoglobin
hemoglobin level postpartum
Change in hemoglobin concentration from labor admission to postpartum day 1
Hemoglobin change between labor admission and postpartum
Rate of maternal transfusion of blood or blood products postpartum
Transfusion of blood or blood products postpartum
Number of units of blood products transfused
Number of units of blood products transfused
Volume of blood loss post-randomization
An estimate of blood loss from the time of randomization
Surgical procedures performed
Surgical procedures performed, including uterine vascular ligation, uterine compression sutures or hysterectomy
Rate of maternal death postpartum
Maternal death postpartum up to 6 weeks
Number of additional uterotonic used after randomization
Type and number of uterotonic used after the first line oxytocin
Patient satisfaction assessed by a score on a scale of 0 (least satisfied) to 10 (most satisfied)
Patient satisfaction assessed by a score on a scale of 0 (least satisfied) to 10 (most satisfied)
Composite adverse events potentially related to the Jada system
Composite adverse events potentially related to the Jada system, including genital tract injury, uterine perforation or rupture and endometriosis
Quality-adjusted Life-year
Quality-adjusted Life-year based on the literature and Quality of Life Questionnaire (EQ-5D-5L)
Incremental cost per quality-adjusted life-year
Incremental cost per quality-adjusted life-year

Full Information

First Posted
May 15, 2022
Last Updated
June 27, 2023
Sponsor
Women and Infants Hospital of Rhode Island
Collaborators
Washington University School of Medicine, University of Ghana, Kwame Nkrumah University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT05382403
Brief Title
Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage
Acronym
NOVIC
Official Title
Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage: a Multicenter Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
August 31, 2026 (Anticipated)
Study Completion Date
April 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Women and Infants Hospital of Rhode Island
Collaborators
Washington University School of Medicine, University of Ghana, Kwame Nkrumah University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This will be the first, definitive, randomized control trial (N=424) to test the hypothesis that the Jada® System is effective, safe and cost-effective in treating PPH, compared to standard care.
Detailed Description
Every year, 130 million women deliver babies around the world, and an estimated 14 million (11%) experience postpartum hemorrhage (PPH), recently redefined as a cumulative blood loss of 1000 ml or more or blood loss associated with signs or symptoms of hypovolemia, irrespective of the route of delivery. PPH is the leading cause of maternal mortality worldwide, responsible for 25% of maternal deaths from obstetric causes, with 99% occurring in low and middle income countries (LMICs). Although PPH has multiple causes, the most common is uterine atony when the uterus fails to adequately contract after childbirth, accounting for 70% of all PPH. Active management of the third stage of labor, consisting of administering prophylactic uterotonics, controlled cord traction, and uterine massage after delivery, reduces the incidence of PPH by approximately 66%. These conservative measures facilitate the normal postpartum tetanic myometrial contractions that constrict the placental bed vasculature. When PPH occurs in spite of these preventive measures, therapeutic options include additional uterotonics (medical), uterine tamponade (mechanical) and surgical interventions (vascular ligation, uterine compression sutures and hysterectomy). Uterine balloon tamponade is often the second line therapy when medical management is unsuccessful and is achieved with inflatable devices inserted into the uterus to exert outward compression on the uterine walls. Despite its widespread use, its mechanism is counterintuitive to the physiologic uterine contraction that occurs after delivery to control bleeding. Its use is further limited by prolonged treatment times (typically 12-24 hours), urinary tract occlusion, and inability to reveal any continuing bleeding. Low-cost options most commonly condom catheters are used in LMICs, but two recent randomized trials showed no improvement in maternal outcomes and possible harm. Thus, there is an urgent need for effective and safe treatment options to reduce the burden of PPH particularly in LMICs. The Jada® System (Alydia Health, Menlo Park, CA, USA) is a novel U.S. FDA-cleared intrauterine vacuum-induced hemorrhage-control device specifically designed for rapid treatment of PPH. It mimics postpartum physiology by applying low-level intrauterine negative pressure to facilitate uterine compressive forces for constriction of blood vessels to achieve hemostasis. Preliminary data from two studies have shown promising results. The device was first evaluated in a feasibility case series (n=10) in Indonesia and showed rapid treatment of abnormal postpartum uterine bleeding.6 The second larger study, a multicenter single-arm trial (n=106) in the United States, confirmed quick and definitive control of bleeding in 94% of cases within a median time of 3 minutes and few adverse events. While promising, these data are limited by lack of control groups, possible selection bias and the modest sample sizes which preclude definitive conclusions regarding the relative effectiveness and safety of the Jada® System. We propose the first, definitive, randomized control trial (N=424) to test the hypothesis that the Jada® System is effective, safe and cost-effective in treating PPH, compared to standard care. A multidisciplinary team of investigators with expertise in obstetrics, global health and clinical trials will enroll 424 women in two high volume obstetric units in Ghana, a LMIC with high PPH burden, to pursue the following specific aims: Primary Aim: Evaluate the effectiveness of the Jada® System, compared to standard care, in treating PPH. Secondary Aim 1: Assess the safety of the Jada® System, compared to standard care, in treating PPH. Secondary Aim 2: Estimate the cost-effectiveness of the Jada® System, compared to standard care, in treating PPH.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage, Maternal Death

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
424 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Jada® System
Arm Type
Experimental
Arm Description
Patients in this group will have the Jada® System applied when the initial medical treatment fails, and estimated blood loss reaches 1000 mL. It is a U.S. FDA-cleared device intended for treatment of PPH when conservative management is warranted.
Arm Title
Standard care
Arm Type
Active Comparator
Arm Description
Patients in this group will receive care according to the treatment algorithm for PPH from uterine atony at the two teaching hospitals in Ghana. Possible interventions include additional uterotonics, tranexamic acid, and condom catheter balloon uterine tamponade. If bleeding is uncontrolled, patients will have surgical intervention with options of uterine vascular ligation, uterine compression sutures or hysterectomy
Intervention Type
Device
Intervention Name(s)
Jada® System
Intervention Description
This is a U.S. FDA-cleared device intended for treatment of PPH when conservative management is warranted. The device is made of medical grade silicone. The distal end, which is placed in the uterus, is an elliptical loop. The circular cervical seal, just outside the external cervical os, is filled with 60 - 120 mL sterile water. Low-level vacuum (80 ± 10 mm Hg) is applied and pooled blood is evacuated from the uterus as it collapses. Once there is no bleeding, the device remains in the uterus for at least 1 hour. The suction is then disconnected, the seal emptied of water, the device left in place, and the patient monitored for an additional 30 minutes. If bleeding remains controlled, the device is removed. If bleeding is uncontrolled with the Jada® System patients will have surgical intervention with options of uterine vascular ligation, uterine compression sutures or hysterectomy.
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
Patients in this group will receive care according to the treatment algorithm for PPH from uterine atony at the two teaching hospitals in Ghana. Possible interventions include additional uterotonics, tranexamic acid, and condom catheter balloon uterine tamponade. If bleeding is uncontrolled, patients will have surgical intervention with options of uterine vascular ligation, uterine compression sutures or hysterectomy.
Primary Outcome Measure Information:
Title
Maternal survival without surgical intervention
Description
No maternal death postpartum up to 6 weeks and no use of surgical interventions
Time Frame
Delivery to 6 weeks post-delivery
Secondary Outcome Measure Information:
Title
Time from randomization to control of bleeding
Description
Time from use of first line treatment to control of bleeding
Time Frame
6 weeks postpartum
Title
Concentration of postpartum hemoglobin
Description
hemoglobin level postpartum
Time Frame
Postpartum day 1
Title
Change in hemoglobin concentration from labor admission to postpartum day 1
Description
Hemoglobin change between labor admission and postpartum
Time Frame
Postpartum day 1
Title
Rate of maternal transfusion of blood or blood products postpartum
Description
Transfusion of blood or blood products postpartum
Time Frame
6 weeks postpartum
Title
Number of units of blood products transfused
Description
Number of units of blood products transfused
Time Frame
6 weeks postpartum
Title
Volume of blood loss post-randomization
Description
An estimate of blood loss from the time of randomization
Time Frame
6 weeks postpartum
Title
Surgical procedures performed
Description
Surgical procedures performed, including uterine vascular ligation, uterine compression sutures or hysterectomy
Time Frame
6 weeks postpartum
Title
Rate of maternal death postpartum
Description
Maternal death postpartum up to 6 weeks
Time Frame
6 weeks postpartum
Title
Number of additional uterotonic used after randomization
Description
Type and number of uterotonic used after the first line oxytocin
Time Frame
6 weeks postpartum
Title
Patient satisfaction assessed by a score on a scale of 0 (least satisfied) to 10 (most satisfied)
Description
Patient satisfaction assessed by a score on a scale of 0 (least satisfied) to 10 (most satisfied)
Time Frame
6 weeks postpartum
Title
Composite adverse events potentially related to the Jada system
Description
Composite adverse events potentially related to the Jada system, including genital tract injury, uterine perforation or rupture and endometriosis
Time Frame
6 weeks postpartum
Title
Quality-adjusted Life-year
Description
Quality-adjusted Life-year based on the literature and Quality of Life Questionnaire (EQ-5D-5L)
Time Frame
6 weeks postpartum
Title
Incremental cost per quality-adjusted life-year
Description
Incremental cost per quality-adjusted life-year
Time Frame
6 weeks postpartum

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or older Delivery at 34 weeks or greater Cumulative blood loss >1000ml within 24 hours after delivery Uterine atony Receipt of first-line uterotonics Cervix at least 3cm dilated at cesarean section Exclusion Criteria: Patient unwilling or unable to provide informed consent Retained placenta or other known cause of postpartum hemorrhage Placenta accreta spectrum Coagulopathy Rupture uterus Surgical management immediately needed for life-threatening bleeding Known contraindication for Jada System; ongoing intrauterin pregnancy, untreated uterine rupture, unresolved uterine inversion, current cervical cancer, unknown uterine anomoly, current purulent infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Crystal Ware, BSN, CCRP
Phone
401-274-1122
Email
cware@wihri.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Methodius Tuuli, MD, MPH, MBA
Organizational Affiliation
Women and Infants Hospital of Rhode Island
Official's Role
Principal Investigator
Facility Information:
Facility Name
Komfo Anokye Teaching Hospital
City
Kumasi
State/Province
Ashanti Region
Country
Ghana
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edward Dassah, MBChB, PhD
Facility Name
Korle-bu Teaching Hospital
City
Accra
State/Province
Greater Accra Region
Country
Ghana
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samuel Oppong, MBChB

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be collected from human subjects and will be shared according to NIH guidelines. We are committed to the sharing of final data, being mindful that the rights and privacy of people who participate in research must be protected at all times. We will make a complete study dataset available for sharing. We will have a description of study dataset, including code books, meta-data related to the dataset, and documented programming code used for creating the final study population, for creating variables, and for conducting all outcomes analyses. We will remain HIPAA compliant, and therefore any datasets resulting from participants will be free of any identifiers that would permit linkages to individual research participants and variables that could lead to deductive disclosure of individual subjects.
IPD Sharing Time Frame
5 years after completion of trial.
IPD Sharing Access Criteria
We will make the data and associated documentation available to users under a data-sharing agreement that provides for commitment to: a) using the data only for research purposes and not to identify any individual participant; b) securing the data using appropriate computer technology; and c) destroying or returning the data after analyses are completed. Timelines for distribution of data will vary depending on any required restrictions as mentioned above. Data may be distributed by a number of electronic methods, including web-based databases, datasets, and spreadsheets, or via electronic media such as compact discs.

Learn more about this trial

Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage

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