Balloon Tamponade Versus Gauze Packing for Postpartum Hemorrhage

NCT07609589 | Not Yet Recruiting

• 1 other identifier: 885/DME/KMC
• Study Type: interventional
• Target: 216
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Postpartum Hemorrhage; Uterine Atony

Keywords

postpartum hemorrhage; uterine atony; balloon tamponade; uterine packing

Outcome Measures

Primary Outcomes (1)

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

  24 hours after intervention

Study Arms (2)

Uterine Balloon Tamponade

EXPERIMENTAL

Procedure: Uterine Balloon Tamponade

Uterine Gauze Packing

ACTIVE COMPARATOR

Procedure: Uterine gauze packing

Interventions

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 Balloon Tamponade

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.

Uterine Gauze Packing

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Khyber Teaching Hospital: lead

MeSH Terms

Conditions

Postpartum Hemorrhage; Uterine Inertia

Interventions

Uterine Balloon Tamponade

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; Dystocia

Intervention Hierarchy (Ancestors)

Balloon Occlusion; Catheterization; Therapeutics; Endotamponade; Hemostatic Techniques; Embolization, Therapeutic; Therapeutic Occlusion; Investigative Techniques

Central Study Contacts

Madiha Yar Khan

CONTACT

+923486106764; madihak067@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 27, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): January 10, 2027
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share