Balloon Tamponade Versus Gauze Packing for Postpartum Hemorrhage

Postpartum hemorrhage due to uterine atony is a major cause of maternal morbidity and mortality. This randomized controlled trial aims to compare the efficacy of uterine balloon tamponade and uterine gauze packing in controlling bleeding in women with postpartum hemorrhage. A total of 216 participants will be randomly assigned to one of the two treatment groups. All patients will receive standard medical management including uterotonic agents prior to intervention. The primary outcome is cessation of uterine bleeding within 24 hours after the procedure. This study aims to identify a safe and effective method for managing postpartum hemorrhage in a resource-limited setting.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Postpartum Hemorrhage Dystocia Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Atony Uterine Hemorrhage Uterine Inertia

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Women aged 18 to 40 years
Gestational age between 37 and 42 weeks
Parity up to 4
Diagnosed with postpartum hemorrhage due to uterine atony

Exclusion criteria

Postpartum hemorrhage due to perineal, cervical, or vaginal trauma
Retained products of conception
Vaginal delivery after previous cesarean section
Known coagulation disorders
Sepsis

Treatment and study plan

Uterine Balloon Tamponade

Procedure

Uterine balloon tamponade will be performed using sterile Foley catheters inserted into the uterine cavity and inflated with normal saline to achieve hemostasis in patients with postpartum hemorrhage due to uterine atony, following standard aseptic techniques.

Uterine gauze packing

Procedure

Uterine gauze packing will be performed using sterile gauze placed within the uterine cavity and vagina to apply pressure and control bleeding in patients with postpartum hemorrhage due to uterine atony, following standard aseptic techniques.

Primary outcomes

Successful Control of Postpartum Hemorrhage Assessed by Cessation of Active Uterine Bleeding Without Need for Additional Surgical Intervention

Time frame: 24 hours after intervention

Successful control of postpartum hemorrhage will be defined as cessation of active uterine bleeding within 24 hours after uterine balloon tamponade or uterine gauze packing, without the need for additional surgical procedures (e.g., hysterectomy, arterial ligation, or repeat tamponade/packing), as assessed clinically by the treating obstetric team.

Study contacts

Contact information is provided by the study sponsor or research team.

Madiha Yar Khan

CONTACT

[email protected]

+923486106764

Sponsors and collaborators

Lead sponsor

Khyber Teaching Hospital

Other

Registry information

Official study title

Comparison of Efficacy of Uterine Balloon Tamponade Versus Uterine Gauze Packing in Patients With Postpartum Hemorrhage With Uterine Atony

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2027
First posted: May 27, 2026
Registry last updated: May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting