Efficacy of Balloon Tamponade in Post-partum Hemorrhage Within 24 Hours After Delivery (BT-PPH)
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.
調査の概要
詳細な説明
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:
- 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.
- 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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Maryam Aslam, MBBS
- 電話番号：03038059729
- メール：aslammaryam18@gmail.com
研究場所
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Punjab Province
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Faisalābad、Punjab Province、パキスタン、38000
- Aziz Fatima hospital
-
コンタクト：
- Maryam Aslam, MBBS
- 電話番号：03038059729
- メール：aslammaryam18@gmail.com
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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.
説明
Inclusion Criteria:
- Age 18-35 years
- Having gestational age between 31 to 41 weeks
- Having PPH (Primary postpartum hemorrhage unresponsive to uterotonics)
Exclusion Criteria:
- 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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：OTHER
- 時間の展望：CROSS_SECTIONAL
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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. |
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Efficacy of intrauterine condom catheter balloon tamponade in control of primary postpartum hemorrhage
時間枠：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. |
Within 6 hours of intervention and assessed for 30 minutes after deflation
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- AFH-OBG-PPH-2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Individual participant data will not be shared due to institutional ethical restrictions and confidentiality of this academic dissertation project at Aziz Fatimah Hospital Faisalabad.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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