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临床试验/CTRI/2024/02/063299
CTRI/2024/02/063299尚未招募Phase 3 4

To compare maternal and fetal outcome in spontaneous labor and induced labor beyond 40 weeks of gestation.

Dr Meenakshi Thakur1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2024年3月11日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
128
试验地点
1
主要终点
To compare maternal and fetal outcome in spontaneous labor and induced labor (with misoprostol 25 mcg 4 doses 4 hour apart) beyond 40 weeks of gestation.

研究概览

简要总结

It will be a hospital based prospective comparative study conducted in the Department of Obstetrics and Gynecology at Dr RPGMC Tanda at Kangra which will include all the pregnant women who have crossed their expected date of delivery meeting the inclusion and exclusion criteria admitted to labor/obstetrics ward for delivery over a period of 1 year. 

The obstetric outcomes of induced and spontaneous groups beyond term shall be analysed to finalise a rationale whether induction of labor should be done at period of gestation beyond expected date of delivery or patient should be allowed to go into spontaneous labor after expected date of delivery.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • 1.Pregnancy beyond 40 weeks of gestational age up to 42 weeks with regular menstrual cycles, with sure LMP and first trimester scan if available 2.Singleton pregnancy.
  • 3.Cephalic presentation.

排除标准

  • 1.Premature rupture of membranes 2.Associated medical problems like diabetes mellitus, cardiac diseases, renal diseases, pre-eclampsia.
  • 3.Contraindication to induction of labor such as intrauterine growth restriction, fetal distress (non-reactive CTG), cephalopelvic disproportion, placenta previa, chronic placental insufficiency, abnormal fetal presentations (transverse lie or breech),cord presentation.
  • 4.Previous cesarean section 5.Mode of induction other than misoprostol 25 mcg sublingually.

结局指标

主要结局

To compare maternal and fetal outcome in spontaneous labor and induced labor (with misoprostol 25 mcg 4 doses 4 hour apart) beyond 40 weeks of gestation.

时间窗: To compare maternal and fetal outcome in spontaneous labor and induced labor (with misoprostol 25 mcg 4 doses 4 hour apart) beyond 40 weeks of gestation.

次要结局

  • comfort of patient in labour(1 year)

研究者

发起方
Dr Meenakshi Thakur
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Meenakshi Thakur

Dr Rajendra Prasad Government College Tanda At Kangra

研究点 (1)

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