NCT01980173终止不适用
Medico-economic Comparison of Postpartum Hemorrhage Management Using the Bakri Balloon and Standard Care
Centre Hospitalier Universitaire de Nīmes7 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2014年9月5日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 26
- 试验地点
- 7
- 主要终点
- The % of patients requiring invasive measures for postpartum hemorrhage control.
研究概览
简要总结
This study concerns women diagnosed with postpartum hemorrhage and requiring sulprostone therapy. Included patients are randomized to two arms: the "Sulprostone + Bakri balloon" arm versus the "Sulprostone alone" arm.
The main objective of this study is to compare the efficiency of a care strategy including the Bakri balloon to that of routine care without the Bakri balloon via a cost-consequence study juxtaposing costs and the necessity of invasive procedures (arterial embolization, ligation of arteries, hysterectomy, intrauterine sutures) for controlling postpartum hemorrhage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The patient, her person-of-trust, must have given his/her consent and signed the consent form / inclusion decision made by the investigator when a person-of-trust is absent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient is able to fluently read and speak French
- •Blood loss > 500ml and sulprostone treatment is insufficient at 20 minutes
- •Duration of pregnancy > 32 weeks of amenorrhea
- •Uterine atony
排除标准
- •The patient is participating in another study except for the followin studies: ElastoMAP, ElastoDéclench, Papillo PMA, GrossPath, LXRs, DGPostPartum
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient refuses to sign the consent
- •It is impossible to correctly inform the patient
- •The patient cannot read French
- •The patient was transferred to another center not among the centers participating in this study
- •The patient has a contraindication for a treatment used in this study (Sulprostone), or an incompatible treatment combination
- •The patient has a contraindication for third level techniques
- •The patient has at least one of the following conditions: chorioamnionitis, cervical cancer, uterine rupture, anatomical abnormality preventing the introduction of the device, purulent infection of the vagina, cervix or uterus.
研究组 & 干预措施
With Bakri balloon
Experimental
Patients randomized to this arm will be treated using the Bakri balloon.
Intervention: Bakri balloon
干预措施: Bakri balloon (Device)
Without Bakri balloon
Active Comparator
Patients randomized to this arm will receive routine care not including the Bakri Balloon.
Intervention: Routine Care
干预措施: Routine care (Procedure)
结局指标
主要结局
The % of patients requiring invasive measures for postpartum hemorrhage control.
时间窗: Hospital stay (expected max of 15 days).
The total cost (€) associated with the postpartum hemorrhage management strategy.
时间窗: Hospital stay (expected max of 15 days).
次要结局
- Vascular filling required? yes/no(Day 0)
- If vascular filling is required, volume and type of solution used.(Day 0)
- Blood loss (ml) 2 hours after diagnosis(2 hours after diagnosis (day 0))
- Blood pressure(when performing invasive techniques (expected day 0 or 1))
- The % of patients requiring intravenous iron.(Hospital stay (expected max of 15 days).)
- Doppler ultrasound: intraluminal pressure(when placing the Bakri balloon; day 0)
- Doppler ultrasound: uterine artery pulsatility index(when placing the Bakri balloon; day 0)
- Blood loss (ml) 30 minutes after diagnosis(30 minutes after diagnosis (day 0))
- Blood loss (ml) 1 hour after diagnosis(1 hour after diagnosis (day 0))
- Prothrombin (%)(Day 3)
- Activated partial thromboplastin time (s)(Day 2)
- Doppler ultrasound: inversed diastolic flow(when placing the Bakri balloon; day 0)
- IES-R scale (symptoms of post-traumatic stress)(6 months)
- Fibrinogen (g / l)(Day 3)
- Hematocrit (%)(the month preceding delivery)
- Length of ICU stay(expected max of 15 days)
- Antimullerian hormone level(2 months after restart of menses)
- The presence of adhesions detected at hysteroscopy(3 months after delivery if menses have restarted, or 2 months after the restart of menses (maximum of 1 year after inclusion))
- The percentage of patients still bleeding 30 minutes after sulprostone injection(30 minutes after sulprostone injection (day 0))
- Blood loss (ml) 24 hours after diagnosis(24 hours after diagnosis (day 1))
- Amenorrhea at 3 months? yes/no(3 months)
- temperature (°C)(Daily while in hospital (expected maximum of 15 days))
- FSFI questionnaire (Female Sexual Function Index)(6 months)
- The delay required to stop bleeding post-delivery (min)(post-partum (expected maximum of a few hours))
- The delay required to stop bleeding post-diagnosis (min)(post-partum (expected maximum of a few hours))
- Heart rate(when performing invasive techniques (expected day 0 or 1))
- The % of patients requiring blood transfusion.(Hospital stay (expected max of 15 days).)
- The quantity of packed red cells, platelet concentrate and fresh frozen plasma consumed(Hospital stay (expected max of 15 days).)
- Hemoglobin (g/dl)(the month preceding delivery)
- Length of hospital stay (days)(Expected max of 15 days)
- pain will be assessed in both arms via a visual analog scale, duration, location, and use of analgesics(Day 3)
- Doppler ultrasound: intrauterine pressure(when placing the Bakri balloon; day 0)
- Doppler ultrasound: thickness of the uterine wall(when placing the Bakri balloon; day 0)
- Doppler ultrasound: uterine artery perfusion pressure(when placing the Bakri balloon; day 0)
- Were amines required? yes/no(Day 0)
- Blood pressure(24 hours after diagnosis (day 1))
- Heart rate(30 minutes after diagnosis (day 0))
- Blood pressure(Upon diagnosis (day 0))
- Blood pressure(30 minutes after diagnosis (day 0))
- Blood pressure(120 minutes after diagnosis (day 0))
- Heart rate(120 minutes after diagnosis (day 0))
- Blood pressure(upon sulprostone injection (day 0))
- Blood pressure(when placing the Bakri balloon (day 0))
- Heart rate(24 hours after diagnosis (day 1))
- Fibrinogen (g / l)(Day 1)
- Heart rate(upon sulprostone injection (day 0))
- Heart rate(when placing the Bakri balloon (day 0))
- Fibrinogen (g / l)(Upon diagnosis (day 0))
- Heart rate(Upon diagnosis (day 0))
- Hematocrit (%)(Upon diagnosis (day 0))
- Hematocrit (%)(Day 1)
- Hematocrit (%)(Day 3)
- Hemoglobin (g/dl)(Upon diagnosis (day 0))
- Hemoglobin (g/dl)(Day 1)
- Hemoglobin (g/dl)(Day 3)
- Prothrombin (%)(the month preceding delivery)
- Prothrombin (%)(Upon diagnosis (day 0))
- Prothrombin (%)(Day 1)
- Activated partial thromboplastin time (s)(the month preceding delivery)
- Activated partial thromboplastin time (s)(Upon diagnosis (day 0))
- Activated partial thromboplastin time (s)(Day 1)
- Antimullerian hormone level(Upon diagnosis (Day 0))
- pain will be assessed in both arms via a visual analog scale, duration, location, and use of analgesics(Day 1)
研究者
研究点 (7)
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