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

Completed

Conditions: Gestational [pregnancy-induced] hypertension without significant proteinuria, second trimester, (2) ICD-10 Condition: O140||Mild to moderate pre-eclampsia,

Registration Number: CTRI/2022/08/045008

Lead Sponsor: Vinayaka Missions Research Foundation Deemed to be University

Brief Summary: Maternal safety refers to the safe care of womengiven during antenatal, intranatal and postnatal periods. The health outcome ofpregnant women lies in the hands of health care providers. Hypertensive disordersduring pregnancy are the most common cause of mortality and have an increased riskof obstetric complications. Anxiety during pregnancy increase the likelihood ofpregnancy-induced hypertension. Therefore, there is anurgent need for new and different methods of treating hypertension duringpregnancy, particularly non-pharmacological options.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 150

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maternal Outcome - Gestational age at delivery, mode of delivery, blood pressure, maternal morbidity and length of hospital stay	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
Newborn outcome: Birth weight of baby, gestational week of baby, APGAR score, neonatal mortality and morbidity	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 Outcome Measures

Name	Time	Method
Improved knowledge on maternal safety bundle, reduced level of anxiety, good level of medication adherence, reduced length of hospital stay and improved maternal satisfaction.	1. knowledge on maternal safety bundle at 20 weeks, and 24 weeks of gestation(after 4 weeks of intervention) - 2 points

Trial Locations

Locations (1): Government Head Quarters Hospital
🇮🇳
Cuddalore, TAMIL NADU, India
Government Head Quarters Hospital
🇮🇳Cuddalore, TAMIL NADU, India
Mrs Alby Johnson
Principal investigator
7600989396
albyp123@gmail.com