Efficacy of Balloon Tamponade in Post-partum Hemorrhage Within 24 Hours After Delivery

NCT07845240 | Not Yet Recruiting

• 1 other identifier: AFH-OBG-PPH-2026
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

Postpartum hemorrhage (PPH) is a major cause of maternal death, especially in developing countries like Pakistan where it accounts for up to 34% of maternal deaths. When bleeding after delivery does not stop with medicines like oxytocin and uterine massage, a low-cost method called balloon tamponade can be life-saving. This study titled "Efficacy of Balloon Tamponade in Post-partum Hemorrhage within 24 Hours After Delivery" will be conducted by Dr. Maryam Aslam (PGR Gynecology and Obstetrics) under supervision of Prof. Dr. Raheela Farhat at Aziz Fatima Hospital, Faisalabad. The objective is to determine the efficacy of intrauterine balloon tamponade (condom catheter balloon) in controlling primary PPH. Efficacy is defined as successful control of bleeding within six hours of balloon insertion without need for additional surgery, confirmed by absence of active vaginal bleeding, a contracted uterine fundus, and stable maternal condition after removal of the balloon. The results will help promote a simple, effective procedure that can even be used by primary health care workers to reduce maternal mortality.

Conditions

Postpartum Hemorrhage

Keywords

Balloon Tamponade

Outcome Measures

Primary Outcomes (1)

• Efficacy of intrauterine condom catheter balloon tamponade in control of primary postpartum hemorrhage

  Efficacy is defined as successful control of primary PPH within 6 hours of balloon insertion without need for additional surgical intervention. Success confirmed by absence of active vaginal bleeding, contracted uterine fundus on abdominal palpation and stable maternal vital signs and general condition. Failure defined as persistent bleeding or rising fundus requiring surgical intervention.

  Within 6 hours of intervention and assessed for 30 minutes after deflation

Study Arms (1)

This cohort includes 121 women aged 18-35 years with gestational age 31-41 weeks who developed prima

A condom-lined sterile rubber catheter will be inserted into the uterus under strict aseptic conditions. Balloon placed on cervix and held with roller gauze and sponge-holding forceps. Balloon inflated with 300-400 ml of regular normal saline and kept for up to six hours. If no active bleeding detected through cervix and uterine fundus felt contracted after 6 hours, balloon will be slowly deflated at rate of 50 ml/hour to half its volume in 2 hours. If no further bleeding during next 30 minutes, balloon removed in presence of senior staff. If bleeding persists or fundus rises, tamponade abandoned and surgical intervention pursued. Efficacy defined as successful control of PPH within six hours of insertion without need for additional surgery, confirmed by absence of active vaginal bleeding, contracted uterine fundus and stable maternal condition.

Device: Intrauterine Balloon Tamponade - Condom Catheter

Interventions

Intrauterine Balloon Tamponade - Condom Catheter DEVICE

Condom-lined sterile rubber catheter inserted into uterus under aseptic technique, held with roller gauze and sponge-holding forceps. Balloon inflated with 300-400 ml normal saline and kept up to 6 hours. If no active bleeding and uterine fundus contracted after 6 hours, balloon deflated at 50 ml/hour to half volume in 2 hours then removed if no bleeding in next 30 min in presence of senior staff. If bleeding persists, tamponade abandoned and surgical intervention pursued. Efficacy is successful control of PPH within 6 hours without additional surgery, confirmed by absence of active vaginal bleeding, contracted fundus and stable maternal condition.

This cohort includes 121 women aged 18-35 years with gestational age 31-41 weeks who developed prima

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women aged 18-35 years with gestational age 31-41 weeks presenting with primary postpartum hemorrhage unresponsive to medical management at Department of Obstetrics and Gynaecology, Allied Hospital Faisalabad. Total 121 participants selected via consecutive non-probability sampling as per WHO sample size calculator with 7% margin of error.

You may qualify if:

• Age 18-35 years
• Having gestational age between 31 to 41 weeks
• Having PPH (Primary postpartum hemorrhage unresponsive to uterotonics)

You may not qualify if:

• Patient who has Obstetric hemorrhage (Antepartum Hemorrhage) \<31 weeks of gestation
• Multiparity (Children more than 5)
• Traumatic PPH (cervical and vaginal tears)
• Allergy to latex
• Acute uterine infection (chorioamnionitis)
• Cases with bleeding disorders, ruptured uterus
• Patient whose postpartum hemorrhage is managed successfully with uterine curettage

Sponsors & Collaborators

• Aziz Fatimah Medical & Dental College, Faisalabad: lead

Study Sites (1)

Aziz Fatima hospital

Faisalābad, Punjab Province, 38000, Pakistan

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

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

Central Study Contacts

Maryam Aslam, MBBS

CONTACT

03038059729; aslammaryam18@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Resident, Obstetrics & Gynaecology

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: September 28, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)