Balloon Tamponade for Atonic Primary Postpartum Hemorrhage

NCT ID: NCT02430155

Last Updated: 2017-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-03-04

Brief Summary

Postpartum hemorrhage (PPH) is responsible for around 25% of maternal mortality worldwide reaching as high as 60% in some countries.PPH can also be a cause of long-term severe morbidity, and approximately 12% of women who survive PPH will have severe anemia.

Postpartum hemorrhage has been defined as blood loss in excess of 500 ml in a vaginal birth and in excess of 1 L in a cesarean delivery.For clinical purposes, any blood loss that has the potential to produce hemodynamic instability should be considered a PPH. However, clinical estimates of blood loss are often inaccurate. Primary (immediate) PPH occurs within the first 24 hours after delivery and approximately 70% of these cases are due to uterine atony. Furthermore, uterine tony is defined as the failure of the uterus to contract adequately after the child is born.

Guidelines for the management of postpartum hemorrhage (PPH) involve a stepwise approach including the exclusion of retained products of conception and genital tract trauma. Uterine atony, which is the most common cause, the management of uterine atony is an established stepwise protocol that in many international guidelines.

Uterine massage is recommended for the treatment of PPH. Initiate uterine massages soon as excessive bleeding/uterine atony is identified. Intravenous oxytocin alone still is the recommended uterotonic drug for the treatment of PPH.

If intravenous oxytocin is unavailable or if the bleeding does not respond to oxytocin, intravenous ergometrine, oxytocin-ergometrine fixed dose or a prostaglandin drug (including sublingual misoprostol, 600 mcg) should be given. The use of intrauterine balloon tamponade is recommended for the treatment of primary PPH due to uterine atony in women who do not respond to uterotonics or if uterotonics are not available.

Since 1983, when Goldrath published evidence that inserting a Foley catheter in the uterus and inflating it with water could achieve tamponade, case series and other studies have suggested that various uterine balloon tamponade(UBT) devices may be effective in treating PPH. The studies used various types of UBT devices, including a condom catheter, a Foley catheter, the Sengstaken-Blakemore Esophageal Tube, the Rusch Balloon, and the Bakri Uterine Balloon. In 2007, a systematic review of treatment options for PPH found that 84% success rate of UBT does not significantly vary from surgical treatment outcomes.The World Health Organization (WHO), the International Federation of Gynecology and Obstetrics (FIGO), the American College of Obstetricians and Gynecologists(ACOG), the Royal College of Obstetricians and Gynecologists(RCOG), and the International Confederation of Midwives (ICM) recognize balloon tamponade as a method that could significantly improve the management intractable PPH, especially in low-resource areas.

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 UBT as a recommended second-line intervention for the treatment of PPH in their updated guidelines issued in 2012.

Bakri first published the concept of intrauterine balloon technology in the management of hemorrhage secondary to placenta praevia-accreta during caesarean section with or without bilateral hypo gastric arterial ligation.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 idea of using a condom as a balloon tamponade was first generated and evaluated in Bangladesh by Sayeba Akhter to fill a need and in response to the high cost of commercially available UBT devices.

Conditions

Postpartum Hemorrhage

Keywords

condom-loaded Foley's catheter; Bakri balloon; primary atonic postpartum hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bakri balloon group

The women in this group will be managed by Bakri balloon

Group Type: ACTIVE_COMPARATOR

Bakri balloon

Intervention Type: DEVICE

is a 100% silicone construction, dual channel balloon catheter specifically designed and approved by FDA for intrauterine placement in cases of PPH. The Bakri balloon contains no latex, and therefore can be safely used in patients with latex allergies

Condom loaded Foley's catheter group

The women in this group will be managed by condom loaded Foley's catheter

Group Type: ACTIVE_COMPARATOR

Condom loaded foley's catheter

Intervention Type: DEVICE

Under aseptic precautions a sterile rubber catheter was inserted within the condom and tied near the mouth of the condom by a silk thread.

Interventions

Bakri balloon

is a 100% silicone construction, dual channel balloon catheter specifically designed and approved by FDA for intrauterine placement in cases of PPH. The Bakri balloon contains no latex, and therefore can be safely used in patients with latex allergies

Intervention Type: DEVICE

Condom loaded foley's catheter

Under aseptic precautions a sterile rubber catheter was inserted within the condom and tied near the mouth of the condom by a silk thread.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Women who accept to participate (either the patient or her first-kin if she is unconscious)
• Primary atonic postpartum hemorrhage

Exclusion Criteria

• Traumatic postpartum hemorrhage
• With any suspected (e.g. prolonged rupture of membranes) or clinical evidence of infection
• Pre eclampsia.
• Diabetes mellietus(DM) with pregnancy
• History of Deep venous thrombosis (DVT) or other thromboembolic complication
• Rheumatic heart patients

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Omar Mamdouh Shaaban

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Kellie FJ, Wandabwa JN, Mousa HA, Weeks AD. Mechanical and surgical interventions for treating primary postpartum haemorrhage. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013663. doi: 10.1002/14651858.CD013663.

Reference Type: DERIVED

PMID: 32609374 (View on PubMed)

Other Identifiers

Uterine balloon tamponade

Identifier Type: -

Identifier Source: org_study_id