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临床试验/NCT06154720
NCT06154720已完成不适用

Surgical Site Infection Following Episiotomy Repair in Relation to Routine Use of Postpartum Antibiotic Prophylaxis in Low Risk Population: A Randomized Controlled Trial

Ain Shams University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年9月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
wound infection at site of episiotomy

研究概览

简要总结

Bacterial infections occurring during labor, childbirth, and the puerperium may be associated with considerable maternal and perinatal morbidity and mortality. Antibiotic prophylaxis might reduce wound infection incidence after an episiotomy, particularly in situations associated with a higher risk of postpartum perineal infection, such as midline episiotomy, extension of the incision, or in settings where the baseline risk of infection after vaginal birth is high. However, available evidence is unclear concerning the role of prophylactic antibiotics in preventing infections after an episiotomy.

详细描述

Maternal mortality is unacceptably high worldwide, with an estimated 300,000 women dying in 2017, of which around 200,000 deaths were in sub-Saharan Africa. Maternal infection, leading to sepsis, is a leading contributor to these deaths. Yet data for the incidence and cause of maternal infection are scarce.

Several pre-existing maternal conditions may increase the risk of developing bacterial infections among women expected to have uncomplicated vaginal births. These include conditions such as malnutrition, anemia, bacterial vaginosis, and group B streptococcus infections. In addition, complications during labor and childbirth (e.g. prolonged rupture of membranes, prolonged labor, lacerations of the genital tract and retained products of conception) or provider interventions (e.g. frequent vaginal examinations, operative vaginal birth (forceps, vacuum), and episiotomy) might increase the risk of infection in the puerperium.

Episiotomy is an intended incision taken on the perineum during the second stage of labor considered for indications in which failure to perform it will result in significant perineal rupture.

Spontaneous vaginal delivery (SVD) is one which occurs when a pregnant woman goes into labor without the use of drugs or other techniques to induce labor and she delivers her baby through the vagina (birth canal) without forceps, vacuum extraction, or a cesarean section. Out of the about four million deliveries occurring in the United States each year, most of them are spontaneous vaginal deliveries.

Socioeconomic status (SES) is one of the most important factors associated with medical outcomes. When SES is low, medical care is inadequate and this has been attributed to adverse outcomes. In pregnant women, low SES can increase the risk of adverse pregnancy outcomes.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients who underwent elective episiotomy.
  • Gestational age 37 weeks or more

排除标准

  • Patients with pro-longed rupture of membranes (PROM >24hrs).
  • pro- longed prelabour rupture of membranes (PPROM).
  • Chorioamnionitis.
  • Prolonged second stage of labour (>2hrs).
  • Third- or fourth-degree vaginal tears.
  • Instrumental delivery like forceps or vacuum.
  • Retained placenta and manual removal of placenta and post partum haemorrhage.
  • Anaemic patients.
  • On steroid or immunocompromised status.
  • Diabetic patients

研究组 & 干预措施

Study Group

women who received co-amoxiclav 625gm (Megamox® film-coated tablet formed of clavulanic acid 125 mg + amoxicillin 500 mg) tab twice daily for 3 days after delivery

干预措施: Antibiotics (Drug)

结局指标

主要结局

wound infection at site of episiotomy

时间窗: 6 weeks

Follow up through a visit or telephone call a weekly until 6 weeks

次要结局

  • Urinary tract infection(6 weeks)
  • Intrauterine infection(6 weeks)
  • high temperature(6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marwan Elkady

Assistant Professor

Ain Shams University

研究点 (1)

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