跳至主要内容
临床试验/CTRI/2020/07/026846
CTRI/2020/07/026846招募中不适用

To evaluate the Effectiveness of Antenatal Mother’s Overview List (ANMOL) Mobile Application in terms of Maternal And Fetal Outcome.

Ms Kavita J Gomase1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年1月8日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
b.Loss of consciousness

研究概览

简要总结

This study is a randomized, participant blinde , sealed opaque envelope, observation trail comparing  Antenatal Mother’s Overview List (ANMOL) Mobile Application with   contemporary protocol in terms of Maternal And Fetal Outcome. As the women admitted in labor room of Acharya Vinoba Bhave Rural Hospital, Sawangi (Meghe), Wardha, with >4 cm cervical dilation  and with more than  34 weeks gestation  will be enrolled for the using ANMOL mobile application.

The Primary outcomes of pregnancy studied are:-

·       Maternal severe complications during delivery  (Seizures ,Loss of consciousness ,High grade fever with foul smell, Hemorrhage)

·       Mode of delivery  (Normal delivery ,LSCS,Assisted delivery )

The secondary outcome of pregnancy are

Maternal death

Primary outcome of neonate after delivery

·     APGAR score in 1 min

  • APGAR score in 5 min
  • Weight in gram NICU admission Days  in NICU

  Secondary outcome of neonate: Still birth  and Early neonatal death . Primary outcome will be assessed by observational checklist after delivery and at postnatal period. Secondary outcome will be all –cause mortality at 6 weeks.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Pregnant Women In Labour (>4 Cm Cervical Dilatation) Pregnant Women With More Than 34 Weeks Gestation.

排除标准

  • Pregnant Women With High Risk Pregnancies (Pregnancy Induced Hypertension, Gestational Diabetes Mellitus, Heart Diseases, Renal Diseases, IUGR Pregnant Women With Preterm Labor.

结局指标

主要结局

b.Loss of consciousness

时间窗: Baseline data from the time admission in labour room, | Then every hourly till the delivery. | After delivery every three hourly for 48 hours. | After delivery of baby

c.High grade fever with foul smell

时间窗: Baseline data from the time admission in labour room, | Then every hourly till the delivery. | After delivery every three hourly for 48 hours. | After delivery of baby

Maternal outcome

时间窗: Baseline data from the time admission in labour room, | Then every hourly till the delivery. | After delivery every three hourly for 48 hours. | After delivery of baby

A.Maternal severe complications during delivery

时间窗: Baseline data from the time admission in labour room, | Then every hourly till the delivery. | After delivery every three hourly for 48 hours. | After delivery of baby

a.Seizures

时间窗: Baseline data from the time admission in labour room, | Then every hourly till the delivery. | After delivery every three hourly for 48 hours. | After delivery of baby

b.LSCS

时间窗: Baseline data from the time admission in labour room, | Then every hourly till the delivery. | After delivery every three hourly for 48 hours. | After delivery of baby

c.Assisted delivery ( forceps / ventous)

时间窗: Baseline data from the time admission in labour room, | Then every hourly till the delivery. | After delivery every three hourly for 48 hours. | After delivery of baby

d.Hemorrhage

时间窗: Baseline data from the time admission in labour room, | Then every hourly till the delivery. | After delivery every three hourly for 48 hours. | After delivery of baby

B.Mode of delivery

时间窗: Baseline data from the time admission in labour room, | Then every hourly till the delivery. | After delivery every three hourly for 48 hours. | After delivery of baby

1. APGAR score in 1 min

时间窗: Baseline data from the time admission in labour room, | Then every hourly till the delivery. | After delivery every three hourly for 48 hours. | After delivery of baby

2.APGAR score in 5 min

时间窗: Baseline data from the time admission in labour room, | Then every hourly till the delivery. | After delivery every three hourly for 48 hours. | After delivery of baby

3.Weight in gram

时间窗: Baseline data from the time admission in labour room, | Then every hourly till the delivery. | After delivery every three hourly for 48 hours. | After delivery of baby

a.Normal delivery

时间窗: Baseline data from the time admission in labour room, | Then every hourly till the delivery. | After delivery every three hourly for 48 hours. | After delivery of baby

Fetal outcome

时间窗: Baseline data from the time admission in labour room, | Then every hourly till the delivery. | After delivery every three hourly for 48 hours. | After delivery of baby

4.NICU admission Days in NICU

时间窗: Baseline data from the time admission in labour room, | Then every hourly till the delivery. | After delivery every three hourly for 48 hours. | After delivery of baby

次要结局

  • Maternal outcome :(Maternal death)

研究者

发起方
Ms Kavita J Gomase
申办方类型
Other [self sponsored ]

研究点 (1)

Loading locations...

相似试验