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临床试验/CTRI/2024/07/071623
CTRI/2024/07/071623进行中(未招募)不适用

Comparison of WHO labour care guide with modified partograph on labour outcomes at a tertiary centre in North East India- A Randomized control trial.

Parakh Mittal1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2024年8月10日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
240
试验地点
1
主要终点
Normal vaginal delivery

研究概览

简要总结

This study is regarding comparison of WHO Labour care guide with Modified partograph on labour outcomes. This will be conducted by making two study groups . A sample size of 240 participants will be selected randomly after considering inclusion and exclusion criteria for labour monitoring by either of the two labour monitoring tools. The following outcomes will be analyzed in each group

Primary outcome- normal vaginal delivery

Secondary outcome- duration of active phase of labour, duration of hospital stay, fetal profile- APGAR score at 5

Dated- 30/01/2025

Till now 51 participants have been recruited . 26 in study group A and 25 in study group B and no issues have been encountered yet. Hence this interventional study will be continued as it is and will be updated after every 6 months.

Dated- 28/07/2025

Till now 196 participants have been recruited. 96 in study group A and 100 in study group B and no issues have been encountered yet.

Hence this interventional study will be continued as it is and will be updated again soon.

Dated- 12/10/2025

All 240 participants are recruited successfully including both the study groups. Now we shall proceed with analysis and result.

Dated- 14/02/2026

study has been analyzed and result is obtained.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
15.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Antenatal women with term gestation between 37 and 40 weeks gestation 2) In spontaneous labour 3) Singleton pregnancy.

排除标准

  • Women with any medical comorbidities such as hypertension , diabetes mellitus, renal or pulmonary diseases 2) Women with any obstetrical complication like preterm, multiple gestation, breech , post dated pregnancy or bad obstetrical history 3) Those who were given intrapartum epidural analgesia 4) Any other contraindications of normal vaginal delivery.

结局指标

主要结局

Normal vaginal delivery

时间窗: Mode of delivery will be assessed after 6-7 hours and APGAR score at 5 minutes after birth

次要结局

  • 1) Duration of active phase of labour(2) Duration of hospital stay)

研究者

发起方
Parakh Mittal
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Parakh Mittal

Agartala Government medical college and GB hospital

研究点 (1)

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