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Clinical Trials/CTRI/2024/07/070501
CTRI/2024/07/070501
Not yet recruiting
Not Applicable

A study on effectiveness of midwife led antenatal intervention package on shared awareness of primigravida women and their maternal and neonatal outcome in selected healthcare facility of Uttar Pradesh.

Bindiya Gupta2 sites in 1 country124 target enrollmentStarted: August 1, 2024Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Bindiya Gupta
Enrollment
124
Locations
2
Primary Endpoint
Improved KAP Score

Overview

Brief Summary

The study aims to assess the shared awareness of primigravida women visiting community health centre regarding various aspects of Antenatal Care and visits like Antenatal Assessment, Management of Minor Ailments , Lifestyle Changes during Pregnancy ( diet, nutrition, exercise etc.), Fetal attachment and Stress Management, Child Birth-Preparation and Complication Readiness, Exclusive Breast Feeding, Family Planning  etc. and develop and implement a multicomponent Midwife Led Antenatal Intervention package in the experimental group. The study hypothesized that  primigravida women in experimental group will have increased shared awareness and improved maternal neonatal outcome than primigravida women in control group at p< 0.05.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Participant Blinded

Eligibility Criteria

Ages
19.00 Year(s) to 35.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • 1.Primigravida women in first trimester of pregnancy.
  • 2.Antenatal registered and plan to deliver with the selected healthcare facilities.
  • 3.Singleton pregnancy and willing to keep the pregnancy.

Exclusion Criteria

  • 1.History of habitual abortion.
  • 2.Known case of chronic illness like HT, DM, Psychiatric illness etc.

Outcomes

Primary Outcomes

Improved KAP Score

Time Frame: taken for each trimester of pregnancy | taken within 24 hours of delivery

Maternal Neonatal outcome

Time Frame: taken for each trimester of pregnancy | taken within 24 hours of delivery

Secondary Outcomes

  • Maternal Satisfaction/ opinion measured using a valid tool(taken within 24 hours of delivery)

Investigators

Sponsor
Bindiya Gupta
Sponsor Class
Other [Self funded]
Responsible Party
Principal Investigator
Principal Investigator

Bindiya Gupta

Swami Rama Himalayan University

Study Sites (2)

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