Efficacy of Hydrogen Peroxide ( H2O2) in Controlling Placental Site Bleeding in Caesarian Delivery for Placenta Previa / Accreta Spectrum ( PAS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- control of intra-operative bleeding from placental bed
研究概览
简要总结
Placenta accreta spectrum (PAS), encompassing the terms placenta accreta, increta, and percreta; abnormally invasive placenta; morbidly adherent placenta; and invasive placentation, is a leading cause of life-threatening obstetric haemorrage (1) . Currently, more than 90% of women diagnosed with PAS also have a placenta praevia (2), and the combination of both conditions leads to high maternal morbidity and mortality due to massive haemorrhage at the time of birth . Maternal mortality of placenta praevia with percreta has been reported to be as high as 7% of cases .
Hydrogen peroxide is well-known for its antimicrobial and antiseptic properties. It is used to clean surgical cuts for better localization of bleeding focus in surgery and orthopedics and burn excisions to induce hemostasis . Topical application of hydrogen peroxide was proven to induce hemostasis and reduce operative time in both tonsillectomy and adenoidectomy .
详细描述
- Population of study: A total of 84 pregnant patients with placenta previa / Accreta spectrum.
- Study location: Obstetrics and Gynecology Kasr Al-Ainy Hospital , Faculty of Medicine , Cairo University.
The aim of the study is to evaluate the efficacy of hydrogen peroxide for controlling bleeding from placental bed in caesarian section for placenta previa/ Accreta spectrum (PAS).
• This is a randomized controlled trial including a total number of 84 patients representing study group , randomized in 2 equal groups , using computer generated randomization sheet on (Medcalc ®) .
Group A : hydrogen peroxide group (n=42)
Group B : control group (normal Saline solution) (n=42) .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age from 18-40 years
- •BMI < 35 kg/m2
- •Pregnant patients with placenta previa .
- •Placenta accrete FIGO grade 1 .
- •Vitally stable .
- •Candidate for conservative management.
- •No major intra-operative bleeding.
排除标准
- •Vitally unstable .
- •Massive pre- or intra-operative bleeding.
- •Medical disorders ( e.g. : hypertension , cardiac .... )
- •Placenta accrete , FIGO grades 2 or 3 .
- •Not indicated for conservative management.
研究组 & 干预措施
hydrogen peroxide group
hydrogen peroxide group Irrigation of the placental bed with 100 ml 3% hydrogen peroxide , followed by packing with a towel highly soaked hydrogen peroxide solution (Pozitif Kimya, İstanbul, Turkey) , freshly prepared by a 50% dilution with a normal saline solution.(
干预措施: packing placental site with hydrogen peroxide soaked towels (Drug)
normal Saline solution
Packing the placental bed with a towel soaked with normal Saline solution
干预措施: normal Saline (Drug)
结局指标
主要结局
control of intra-operative bleeding from placental bed
时间窗: 3 minutes after application of topical drug , identified as arrest of bleeding or minimal oozing from placental bed with good general condition & no hemoglobin drop
control of intra-operative bleeding from placental bed
次要结局
- Need for hemostatic sutures , uterine artery ligation , internal iliac artery ligation , hysterectomy(3 minutes after topical application , if bleeding continued)
- immediate maternal complications ( postpartum haemorrage , DIC , hysterectomy , maternal mortality , ICU admission , …)(within 1st 24 hours postoperative)
- Estimated intraoperative blood loss(from begining to end of surgery)
研究者
Bassiony Dabian
lecturer of obstetrics and gynecology
Cairo University