跳至主要内容
临床试验/NCT04888871
NCT04888871Unknown不适用

Randomized Control Trial for Comparison of Prevention and Appropiate Obstetric Interventions for Prolonged Second Stage Labor at Term Pregnancies During Vaginal Delivery

Zeynep Kamil Maternity and Pediatric Research and Training Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
1
主要终点
maternal morbidity

研究概览

简要总结

Randomized Control Trial for Comparison of Prevention and Appropiate Obstetric Interventions for Prolonged Second Stage Labor at Term Pregnancies During Vaginal Delivery.

详细描述

This study includes prolonged second stage phase and not prolonged second phase in pregnant women to singletons at the weeks between 37-42. Fetal head level will be at or below the ischial spines in all patients.Patients with fully dilated cervix will be included in the study and the bladder will be emptied completely on the labor table. Patients diagnosed with fetal distress will not be included in the study.Indicated patients will be randomly divided into three groups; one group will be only subjected to a Fundal Pressure (Kristaller Maneuver), second group will only be subjected to Vacuum Extraction and the third group will be subjected to both Fundal Pressure (Kristaller Maneuver) and Vacuum Extraction. Maternal episiotomy needs presence of second and third degree perineal tears, presence of postpartum hemorrhage and need for blood transfusion , cesarean rates and fetal first and fifth minute Apgar score , fetal blood gas parameters, presence of fetal trauma, need for neonatal intensive care will be evaluated among three randomized groups.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • term pregnancy weeks between 37-42, singleton, vertex presentations
  • prolonged second stage of labor
  • Fetal head is minimum at the level of ischial spin
  • maternal incompatibility during/after second stage of labor
  • complete cervical dilatation

排除标准

  • Fetal distress
  • Uncomplete cervical dilatation
  • twin pregnancies or polycyesia
  • Pregnancy weeks lower than 37weeks
  • other than vertex presentations
  • Fetal Anomalies

结局指标

主要结局

maternal morbidity

时间窗: 3 months

次要结局

未报告次要终点

研究者

发起方
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Resul Karakuş

Specialist

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

研究点 (1)

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