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A study to evaluate the effect of maternal safety bundle among pregnant women

Effectiveness of maternal safety bundle on its outcomes measures. - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/08/045008
Enrollment
150
Registered
2022-08-29
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O132- Gestational [pregnancy-induced] hypertension without significant proteinuria, second trimester Health Condition 2: O140- Mild to moderate pre-eclampsia

Interventions

Intervention1: Maternal Safety Bundle : Maternal safety bundle is a set of evidence-based guidelines, adapted in local circumstances, to optimally manage a medical condition and thus reduce maternal m

Sponsors

Vinayaka Missions Research Foundation Deemed to be University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: primigravida, 20-24 weeks of gestation, systolic blood pressure more than 140 mmHg, diastolic blood pressure more than 90 mmHg, with or without proteinuria, can understand and speak Tamil and are willing to participate in the study.

Exclusion criteria

Exclusion criteria: antenatal mothers with high-risk conditions like chronic hypertension, gestational diabetes mellitus, placenta previa, multiple pregnancy and chronic diseases.

Design outcomes

Primary

MeasureTime frame
Maternal Outcome - Gestational age at delivery, mode of delivery, blood pressure, maternal morbidity and length of hospital stay Newborn outcome: Birth weight of baby, gestational week of baby, APGAR score, neonatal mortality and morbidityTimepoint: 1. Maternal and newborn outcomes on 2nd the day of delivery- 1 point 2. Blood Pressure at 20 weeks, 25 weeks, 29 weeks, 33 weeks and 37 weeks of gestation and within 48 hours of delivery -6 points

Secondary

MeasureTime frame
Improved knowledge on maternal safety bundle, reduced level of anxiety, good level of medication adherence, reduced length of hospital stay and improved maternal satisfaction.Timepoint: 1. knowledge on maternal safety bundle at 20 weeks, and 24 weeks of gestation(after 4 weeks of intervention) - 2 points 2. Level of anxiety and Medication Adherence at 20 weeks, 24 weeks (after 4 weeks of intervention)and 33 weeks of gestation(after 8 weeks of intervention) - 3 points 3. length of hospital stay at the time of discharge from the hospital - 1 point 4. maternal satisfaction at the time of discharge from the hospital - 1 point

Countries

India

Contacts

Public ContactDr Sasi Vaithilingan

Vinayaka Missions college of nursing

sasi.v@vmcnpdy.edu.in09486199264

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026