The Effect of Pethidine Analgesia on Labor Duration and Maternal-Fetal Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Active phase of labor with pethidine
研究概览
简要总结
Although opioid analgesics are used to treat labor pain, there are still concerns about their side effects.
The researchers in this study; aimed to evaluate the effect of pethidine on active phase duration of labor, labor pain and maternal-neonatal.
50 mg pethidine will be administered intramuscularly to the cases to be included in the study group. The patients in the control group will be given placebo injections.
Vital signs of all cases included in the study will be checked at 0, 5, 15, 30, 45 and 60 minutes. Pain will also be assessed by Visual Analogue Scale (VAS) before injection and at the 1st and 2nd hour after injection. Delivery times, maternal side effects, neonatal apgar scores and fetal findings will be recorded.
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
- 否
入选标准
- •nullipar-multiparous patients;
- •singleton pregnancies 37- 41 weeks (by the last menstrual period).
排除标准
- •maternal respiratory rate < 8 /min,
- •maternal bradycardia (<60 bpm),
- •major fetal congenital anomalies,
- •uterine scar presence from previous pregnancies,
- •malpresentation,
- •antepartum hemorrhage,
- •multiple pregnancy,
- •labor induction,
- •chronic systemic disease,
- •rupture fetal membranes,
- •epidural analgesia.
研究组 & 干预措施
Pethidine group / study group
Study group; patients given pethidine; The partogram was recorded during delivery. Cervical examination was performed at 2 hour intervals. Recorded in the file. 4 cm and greater cervical dilatation; 50 mg intramuscular (IM) injection was given to pethidine. 200 Montevideo units uterine contractions were reached. Maternal vital signs, maternal complications and neonatal APGAR scores were recorded by the clinician 0-5-15-30-45-60 minutes after pethidine injection.
干预措施: pethidine (Drug)
control group
The patients who received placebo injection were included in the control group. Saline was given in placebo.
干预措施: Placebo - Concentrate (Drug)
结局指标
主要结局
Active phase of labor with pethidine
时间窗: during labor
The study group that accepted pethidine injection comprised of 132 patients; The active phase duration was evaluated in minutes.
Labor pain with pethidine
时间窗: during labor
Labor pain VAS scores were determined in both groups just prior to pethidine injection (0.hour), and 1st and 2nd hours after injection. The VAS scale represents pain with a score of 1 to 10. patients scored points on this scale and these scores were recorded. 1 point shows the least pain, 10 points the most-irresistible pain.
次要结局
未报告次要终点
研究者
Pınar Kadirogulları
principal investigator, M.D, Department of Obstetrics and Gynecology
Kanuni Sultan Suleyman Training and Research Hospital