REBOA in Life-threatening Postpartum Hemorrhage (PPH) in Uganda

NCT05598502 | Active Not Recruiting DMC

• 1 other identifier: Mak-UiB 102
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

Background Maternal mortality rates in many low-income countries (LMICs) remain high. The most prominent cause is bleeding after birth, called postpartum haemorrhage (PPH). In a recent report from Uganda, bleeding is the cause of 42% of all maternal deaths in Uganda. Large parts of the monitoring of mothers during active management of third stage of labour is aiming to prevent and early detect PPH and take relevant actions. In spite of this and sometimes in referring mothers to tertiary hospitals, mothers will end up in a challenging condition where quick action is needed. A new method has proven successful for such instances, the Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA). This is a procedure commonly used for trauma of the lower part of the body but rarely used for PPH. A balloon catheter is inserted via the femoral artery in the groin into the aorta and then being inflated. This will prevent blood from passing to the lower part of the body, including the uterus. It will stop the bleeding and allow for the obstetrician to take relevant action. This is a safe procedure for up to 1 hour of balloon occlusion time including repeated short balloon deflations. Objective To assess the efficacy and safety of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in life-threatening postpartum haemorrhage (PPH) in reducing adverse maternal outcome compared to standard of care in Uganda. Study design, setting and population A phase IIb/III, open label, 1:1 randomized clinical trial will be conducted at Kawempe National Referral Hospital, Kampala, Uganda, to evaluate the efficacy and safety of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in life-threatening postpartum haemorrhage (PPH) in reducing adverse maternal outcome compared to standard of care. The inclusion criteria are: a) women with life-threatening PPH and a systolic blood pressure equal to or less than 80 mmHg, b) written consent. The exclusion criterion is prior cardiac arrest or intra-abdominal pregnancy. The sample size of the trial will be 212 participants. Enrolment will follow a group sequential design approach with two interim analyses at 50% and 85% of the total sample size, and a final analysis with full sample size. Utility of the study It is crucial to explore alternative modalities that could prevent adverse maternal outcomes in life-threatening postpartum haemorrhage in Uganda and the rest of the world.

Conditions

Post-partum Hemorrhage

Keywords

REBOA; Resuscitative Endovascular Occlusion of the Aorta

Outcome Measures

Primary Outcomes (1)

• Adverse outcome

  The proportion of participants with a composite outcome of either maternal death (=death within 42 days post-partum) or emergency hysterectomy

  42 days

Secondary Outcomes (7)

• Adverse outcome excluding 'inevitable' hysterectomies

  42 days

• Number of AEs and SAEs

  42 days

• Maternal death

  42 days

• Emergency hysterectomy

  42 days

• Acute kidney injury

  42 days

Other Outcomes (1)

• REBOA insertion time

  1 day

Study Arms (2)

REBOA

EXPERIMENTAL

Addition of REBOA (Resuscitative Endovascular Occlusion of the Aorta)

Device: REBOA, Resuscitative Endovascular Occlusion of the Aorta; Other: National guidelines

National guidelines

ACTIVE COMPARATOR

Treatment according to Uganda national guidelines for post-partum hemorrhage.

Other: National guidelines

Interventions

REBOA, Resuscitative Endovascular Occlusion of the Aorta DEVICE

The balloon catheter is inserted via the common femoral artery in the groin, accessed under ultrasound guidance due to weak femoral pulses, and the puncture is done by the Seldinger technique. The balloon is inserted along a guidewire 25-30 cm, safely below the renal arteries, to be in the right place to stop pelvic hemorrhage including life-threatening post-partum hemorrhage

REBOA

National guidelines OTHER

Standard management of postpartum hemorrhage according to Uganda national guidelines

National guidelines; REBOA

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with life-threatening PPH, defined as either:
• Ongoing PPH and a systolic blood pressure equal to or less than 80 mm Hg, or
• Ongoing PPH, a systolic blood pressure equal to or less than 90 mg Hg and the administration of vasoactive drugs, or
• Ongoing PPH and a systolic blood pressure equal to or less than 90 mg Hg as well as a pulse greater than or equal to 120 beats per minute recorded simultaneously
• and
• Consent, Deferred consent since 3rd September 2024

You may not qualify if:

• Prior cardiac arrest
• Intra-abdominal pregnancy

Sponsors & Collaborators

• Centre For International Health: lead
• Makerere University: collaborator
• Kawempe National Referral Hospital: collaborator
• St. Olavs Hospital: collaborator
• Helse Stavanger HF: collaborator
• University of Liverpool: collaborator
• University of Padova: collaborator

Study Sites (1)

Kawempe National Referral Hospital

Kampala, Uganda

Location

Related Publications (4)

• Stensaeth KH, Sovik E, Haig IN, Skomedal E, Jorgensen A. Fluoroscopy-free Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) for controlling life threatening postpartum hemorrhage. PLoS One. 2017 Mar 29;12(3):e0174520. doi: 10.1371/journal.pone.0174520. eCollection 2017.

  PMID: 28355242 BACKGROUND

• Webster LA, Little O, Villalobos A, Nguyen J, Nezami N, Lilly M, Dariushnia S, Gandhi R, Kokabi N. REBOA: Expanding Applications From Traumatic Hemorrhage to Obstetrics and Cardiopulmonary Resuscitation, From the AJR Special Series on Emergency Radiology. AJR Am J Roentgenol. 2023 Jan;220(1):16-22. doi: 10.2214/AJR.22.27932. Epub 2022 Aug 3.

  PMID: 35920708 BACKGROUND

• Brede JR, Sovik E, Rehn M. Resuscitative endovascular balloon occlusion of the aorta: the postpartum haemorrhage perspective. Crit Care. 2022 Mar 11;26(1):57. doi: 10.1186/s13054-022-03942-0. No abstract available.

  PMID: 35277189 BACKGROUND

• Brede JR, Rehn M. The end of balloons? Our take on the UK-REBOA trial. Scand J Trauma Resusc Emerg Med. 2023 Oct 31;31(1):69. doi: 10.1186/s13049-023-01142-5.

  PMID: 37908007 BACKGROUND

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thorkild Tylleskar, MD, PhD

  University of Bergen, Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The study statistician will be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Individual randomization

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: October 28, 2022
• Study Start: January 17, 2024
• Primary Completion: January 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)