Efficacy of Balloon Tamponade in Post-partum Hemorrhage Within 24 Hours After Delivery (BT-PPH)

This is a Descriptive Cross-Sectional Study.

Title: Efficacy of Balloon Tamponade in Post-partum Hemorrhage within 24 hours after delivery.

Setting: Department of Obstetrics and Gynecology, Aziz Fatima Hospital, Faisalabad.

Duration: Six months after approval from CPSP. Sample Size: 121 patients, calculated by WHO sample size calculator using anticipated proportion 81%, significance level 5%, margin of error 7%.

Sampling Technique: Consecutive non-probability sampling.

Operational Definitions:

1. Postpartum Haemorrhage (PPH): Blood loss of more than 500 ml (one kidney tray) following vaginal delivery and 1000 ml following cesarean section within 24 hours. Estimation by kidney tray method.
2. Efficacy: Successful control of PPH within six hours of balloon insertion, without need for additional surgical intervention. Success is confirmed by absence of active vaginal bleeding, contracted uterine fundus, and stable maternal condition following gradual deflation and removal of the balloon device.

Inclusion Criteria:

• Age 18-35 years
• Gestational age between 31 to 41 weeks
• Having primary PPH

Exclusion Criteria:

• 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 PPH is managed successfully with uterine curettage

Data Collection Procedure:

After approval from Institutional Ethical Committee (Ref: IEC/392-25 dated 30/09/2025) and CPSP, and informed consent from patients. Patients meeting inclusion criteria will be selected. A proforma will be used to document demographic data. Women with PPH who do not improve with uterotonics will be evaluated for treatment with condom and Foley catheter balloon. A condom-lined sterile rubber catheter will be inserted into the uterus under strict aseptic technique. The balloon will be placed on cervix and held with roller gauze and sponge-holding forceps. 300-400 ml of regular normal saline will be used to inflate the condom. The catheter condom will be stored for up to six hours. If no active bleeding is detected through the cervix and uterine fundus is 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 occurs during next 30 minutes, balloon will be removed in presence of senior staff member. If bleeding persists or uterine fundus rises, condom tamponade will be abandoned and surgical intervention will be pursued.

Data Analysis:

Data will be entered into SPSS version 25. Mean and standard deviation will be calculated for quantitative variables such as age, gestational age, blood loss. Frequencies and percentages will be used for categorical variables such as socioeconomic status, education status, booking status, parity, mode of delivery and efficacy. Chi-square test will be applied to efficacy. Effect modifiers like age, gestational age, blood loss, socioeconomic status, education status, booking status, parity, mode of delivery will be controlled by stratification. Post-stratification chi-square test will be applied and P-value <0.05 will be considered statistically significant.