Efficacy of Balloon Tamponade in Post-partum Hemorrhage Within 24 Hours After Delivery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Efficacy of intrauterine condom catheter balloon tamponade in control of primary postpartum hemorrhage
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-35 years
- •Having gestational age between 31 to 41 weeks
- •Having PPH (Primary postpartum hemorrhage unresponsive to uterotonics)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Intrauterine Balloon Tamponade - Condom Catheter (Device)
结局指标
主要结局
Efficacy of intrauterine condom catheter balloon tamponade in control of primary postpartum hemorrhage
时间窗: Within 6 hours of intervention and assessed for 30 minutes after deflation
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.
次要结局
未报告次要终点
研究者
maryam aslam
Postgraduate Resident, Obstetrics & Gynaecology
Aziz Fatimah Medical & Dental College, Faisalabad