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Uterine Tamponade for Treatment of Primary Postpartum Hemorrhage

NCT02568657 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2020-08-12

No results posted yet for this study

Summary

Postpartum hemorrhage (PPH) is responsible for around 25% of maternal mortality worldwide reaching as high as 60% in some countries.

Postpartum hemorrhage is defined as loss of 500 mL or more in a vaginal delivery and 1 Litre or more in a cesarean delivery.Also any blood loss that cause hemodynamic instability should be considered a PPH.

In 2012, WHO updated the guidelines for the management of PPH and retained placenta to include: "The use of intrauterine balloon tamponade is recommended for the treatment of PPH due to uterine atony. This recommendation is now stronger than the previous guidelines. It can be used for women who do not respond to uterotonics or if uterotonics are not available. This procedure potentially can avoid surgery and is appropriate while awaiting transfer to a higher-level facility".Furthermore, FIGO included Uterine balloon tamponade as a recommended second-line intervention for the treatment of PPH in their updated guidelines issued in 2012.

In 2006, the ACOG Practice Bulletin, published by the American College of Obstetricians and Gynecologists, made mention of the Bakri postpartum balloon for its specifically tailored design that enables conservative management of uterine bleeding in cases of uterine atony and other causes of PPH.

The reports demonstrated that balloon tamponade is helpful in managing PPH secondary to a wide variety of causes in resource-poor settings.

One of the new methods that could be used to control PPH is Uterine packing with chitosan-covered gauze or Celox.

Celox Haemostats are dressings with natural material called chitosan to control major haemorrhage including life-threatening bleeding . They are simple and effective, stopping major bleeding.It was first used by military forces to stop sever bleeding in the scene with no other options to stop bleeding. Celox™ granules are actually very high surface area flakes. When they come in contact with blood, Celox™ swells, gels, and sticks together to make a gel like clot, without generating any heat. Celox™ does not set off the normal clotting cascade, it only clots the blood it comes directly into contact with. Celox works on casualties using anticoagulants and anti-platelet therapy such as aspirin .

Conditions

  • Postpartum Hemorrhage

Interventions

DEVICE

Celox group

DEVICE

Bakri Balloon

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-10-31
Completion
2015-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02568657 on ClinicalTrials.gov