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临床试验/NCT02934516
NCT02934516Unknown不适用

Delivery of Impacted Fetal Head During Cesarean Section for Obstructed Labor: Push Method Versus Abdominal Disimpaction With Lower Uterine Segment Support

Assiut University0 个研究点目标入组 66 人开始时间: 2020年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
66
主要终点
Extension of uterine incision

研究概览

简要总结

The study aims to compare maternal and early neonatal outcomes of abdominal disimpaction with lower uterine segment support in comparison to the classic "push" method for delivery of impacted fetal head during Cesarean section for obstructed labor.

详细描述

Obstructed labor refers to failure of labor progress in spite of good uterine contractions and is attributed to mismatch between the size of the presenting part of the fetus and the mother's pelvis. Approximately 8% of maternal deaths worldwide are attributed to obstructed labor and subsequent puerperal infection, uterine rupture, and postpartum hemorrhage.

In these situations, Cesarean section could minimize maternal and neonatal morbidity. However, Cesarean section is challenging when the head is deeply impacted and is associated with high risk of maternal injuries and perinatal injuries. The most common complication is extension of uterine incision which could involve the vagina, bladder, ureters and broad ligament. Neonates are also at risk of skull fractures, cephalhematoma, and subgaleal hematoma mainly due to manipulations. Currently, the most popular approaches for fetal head delivery are the push and pull methods. Although push method seems to be more convenient and does not necessitate extensive experience, it is more significantly associated with extension than the pull method. Although pull method seems to be more safe, it is more difficult to perform and usually warrants an aggressive uterine incision to deliver the fetus. In 2013, investigators published a case series on abdominal disimpaction with lower uterine segment support which basically allows obstetricians to deliver the fetal head through a transverse uterine incision with minimal risk of extensions and neonatal complications. In this study, investigators aim to validate this approach in comparison to the classic push method.

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
Single (Participant)

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

  • Singleton term pregnancy, 37 to 42 weeks of gestation.
  • Cephalic presentation.
  • The cervix is fully dilated.
  • Ruptured membranes.
  • Adequate uterine contractions.
  • Impacted fetal head in maternal pelvis

排除标准

  • Intrauterine fetal death
  • Major fetal anomalies
  • Non-cephalic presentation
  • Multiple pregnancy
  • Preterm caesarean < 37 weeks
  • Abnormal placentation.

结局指标

主要结局

Extension of uterine incision

时间窗: During delivery of the fetus

The incidence of extension of uterine incision

Length of extension of uterine incision

时间窗: During delivery of the fetus

If extension of uterine incision happens, the length of extension will be measured

Injury of the vagina

时间窗: During delivery of the fetus

Extension of uterine incision into the vagina

Injury of the bladder

时间窗: During delivery of the fetus

Extension of uterine incision into the bladder

Injury of the ureter

时间窗: During delivery of the fetus

Extension of uterine incision into the ureter

次要结局

  • Cesarean section operative time(Time from incision to closure of the skin (within 24 hours of recruitment))
  • Intra-operative blood loss(During Cesarean section only)
  • The incidence of postpartum hemorrhage(During the first 24 hours post-operative)
  • Incidence of blood transfusion(During surgery and within the first 24 hours postoperative)
  • Fetal traumatic birth injuries(During Cesarean section (fetal delivery))
  • APGAR score(At 1 and 5 minutes after delivery of the newborn)
  • Need for neonatal admission to neonatal intensive care unit(Within 24 hours of delivery of the newborn)
  • Postoperative infections(1 week of postpartum)

研究者

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

Sherif Abdelkarim Mohammed Shazly

M.B.B.Ch, M.Sc

Assiut University

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