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临床试验/NCT05632796
NCT05632796已完成不适用

Can the Length of the Pfannenstiel Skin Incision be Adjusted According to the Fetal Head During Elective/Planned Cesarean Delivery?

Near East University, Turkey1 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2017年6月1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
发起方
入组人数
115
试验地点
1
主要终点
Final Pfannenstiel incision length

研究概览

简要总结

The purpose of the study is whether the Pfannenstiel skin incision can be adjusted according to the occipitofrontal diameter (OFD) of the fetal head.

详细描述

Eligable nulliparous women delivered at term by elective cesarean section in which Pfannenstiel skin incision was performed according to the occipitofrontal diameter (OFD) of the fetal head were included. Non-vertex presentaions, all emergency cesarean sections, severe preclampsia, women in active phase of the first stage of labor and second stage of labor, placenta pervia and low lying placenta, multiple pregnancies, uncontrolled gestational diabetes mellitus were excluded.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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
是

入选标准

  • •The women older than 18 years
  • •term nulliparous pregnancies (>37w)
  • •primary elective/planned Cesarean delivery
  • •fetuses with vertex presentations
  • •underwent spinal anesthesia

排除标准

  • •all emergency cesarean sections ( fetal distress, third trimester bleeding including abruption of placenta and placenta previa bleeding, arrest of labor in the second phase)
  • •cesarean delivery for severe preeclampsia
  • •cesarean delivery for non-vertex fetal presentations (breech and shoulder presentation)
  • •cesarean delivery for deflexion fetal head presentations (face and brow)
  • •cesarean delivery during active phase of the first stage of labor
  • •cesarean delivery for placenta previa or low-lying placenta,
  • •cesarean delivery for multiple pregnancies
  • •all cesarean deliveries with uncontrolled gestational or non-gestational diabetes mellitus

研究组 & 干预措施

tailored pfannenstiel incision according to the fetal head OFD

Experimental

Pfannenstiel incision performed according to the occipitofrontal diameter of the fetal head

干预措施: Adjusting the Pfannenstiel skin incision according to the occipitofrontal diameter (OFD) of the fetal head. (Procedure)

结局指标

主要结局

Final Pfannenstiel incision length

时间窗: up to 48 months

Pfannenstiel skin incision length measured as milimetre (mm) which was performed according to the fetal occipitofrontal diameter measured with ultrasonography before delivery

difference between the initial and the Pfannenstiel incision length

时间窗: up to 48 months

difference between the initial incision which was adjusted according to the fetal occipitofrontal diameter and the final Pfannenstiel incision in millimetre(mm)

rate of extension of the Pfannensitel skin incision in the study population

时间窗: up to 48 months

percentage of patients who need of extension of the Pfannensitel skin incision in which the novel technique was performed

次要结局

  • duration of cesarean delivery(up to 48 months)
  • time interval between uterine incision and fetal delivery(up to 48 months)
  • evaluation of the fetal acidosis by measuring the umbilical blood ph levels(up to 48 months)
  • cut of the abdominal rectus muscle during delivery of the fetus(up to 48 months)
  • health evaluation of the newborn with Apgar scoring system(up to 48 months)

研究者

发起方
Near East University, Turkey
申办方类型
Other
责任方
Principal Investigator
主要研究者

Baris KAYA

Associate Professor

Near East University, Turkey

研究点 (1)

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