Evaluation of Ipsilateral Tubal Patency After Conservative Medical or Surgical Treatment in Uncomplicated Ectopic Pregnancy, "Hospital General", Angola 2021-2022
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Incidence of Ipsilateral tubal patency
研究概览
简要总结
Ectopic Pregnancy is an entity in which a fertilized ovum is implanted outside its normal place, is considered a public health problem worldwide and is one of the main causes of maternal mortality in the first trimester. The availability of high sensitivity methods of detection of gonadotrophins and the use of high resolution transvaginal ultrasonography have allowed an earlier diagnosis of the same, enabling less aggressive treatments such as the use of parenteral MTX, with the intention of avoiding mutilating surgical treatment , preserving the tube and eventually improving future fertility expectations. The surgical treatment is of choice, this can be laparoscopically or by laparotomy. In this case, we need to preserve fertility, the most indicated is linear salpingostomy; In spite of the existence other techniques.
详细描述
The EP constitutes a frequent obstetric emergency in Angola and the province of Benguela is not exempt from this health problem. Every day we see women with this pathology, to which, most of them, they undergo a mutilating surgical treatment (salpingectomy) that impedes their future reproductive capacity. The procreation in the African continent and especially in Angola, has great social and family implications that can reach the breaking of marriages and family (broadcast and study of the Public Television of Angola in the program "Na lente" no year 2018 Taking into account the importance of procreation in the welfare and stability of the marital relationship.Main Objectiv: To demonstrate the non-inferiority of conservative treatment with MTX in ipsilateral tubal patency after an uncomplicated ectopic pregnancy compared with surgical treatment with linear salpingostomy in the Hospital General, Angola
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
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patient presenting with Ectopic Pregnancy, associated with quantitative titers of βHCG ≥ 100 mUI / ml, without intrauterine gestational sac.
- •Patient presenting uncomplicated Ectopic Pregnancy with an adnexal mass diameter ≤4 cm diagnosed by abdominal and / or transvaginal ultrasonography.
- •Absence of heartbeat. No toxicity to MTX. Normal laboratory tests (blood count, coagulogram, liver and kidney function). Hemodynamic stability.
排除标准
- •Complicated Ectopic Pregnancy.
- •Ectopic pregnancy is out of the tuba on ultrasound
- •Patients with Immunosuppression.
- •Allergy to MTX.
- •Patients with Active Respiratory Disease, Blood Dyspasia, Peptic Ulcer, Renal Insufficiency and Hepatic Insufficiency.
- •Do not accept to participate in the study.
研究组 & 干预措施
Medical treatment
By administering a single intramuscular dose of 50mg / m2 / Sc of Methotrexate.
干预措施: Medical treatment (Drug)
Surgical treatment
Will be performed by laparoscopy or laparotomy, using the Linear Salpingostomy technique.
干预措施: Medical treatment (Drug)
结局指标
主要结局
Incidence of Ipsilateral tubal patency
时间窗: A hysterosalpingography will be performed 3 months after the treatment.
Incidence of Ipsilateral tubal patency
次要结局
- Incidence of Achieve the gestation and the culmination.(Up to two years)
研究者
Eduardo Kedisobua
Medical Surgery
EDGREM Investimentos