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

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

Interventions

DEVICE

REBOA, Resuscitative Endovascular Occlusion of the Aorta

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

OTHER

National guidelines

Standard management of postpartum hemorrhage according to Uganda national guidelines

Sponsors & Collaborators

• Makerere University

  collaborator OTHER

• Kawempe National Referral Hospital

  collaborator UNKNOWN

• St. Olavs Hospital

  collaborator OTHER

• Helse Stavanger HF

  collaborator OTHER_GOV

• University of Liverpool

  collaborator OTHER

• University of Padova

  collaborator OTHER

• Centre For International Health

  lead OTHER

Principal Investigators

• Thorkild Tylleskar, MD, PhD · University of Bergen, Norway

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

60 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-17

Primary Completion

2025-01-31

Completion

2027-12-31

Countries

• Uganda

Study Locations