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CTRI Number  CTRI/2022/08/045008 [Registered on: 29/08/2022] Trial Registered Prospectively
Last Modified On: 23/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Screening
Behavioral 
Study Design  Other 
Public Title of Study   A study to evaluate the effect of maternal safety bundle among pregnant women 
Scientific Title of Study   Effectiveness of maternal safety bundle on its outcomes measures. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mrs Alby Johnson 
Designation  Research Scholar 
Affiliation  Vinayaka Missions Research Foundation Deemed to be University 
Address  Vinayaka Missions college of nursing, Pondy Cuddalore main road, Kirumampakkam

Pondicherry
PONDICHERRY
607402
India 
Phone  7600989396  
Fax    
Email  albyp123@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sasi Vaithilingan 
Designation  Vice Principal & Professor 
Affiliation  Vinayaka Missions college of nursing 
Address  Vinayaka Missions college of nursing, Pondy Cuddalore main road, Kirumampakkam

Pondicherry
PONDICHERRY
607402
India 
Phone  09486199264  
Fax    
Email  sasi.v@vmcnpdy.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Sasi Vaithilingan 
Designation  Vice Principal & Professor 
Affiliation  Vinayaka Missions college of nursing 
Address  Vinayaka Missions college of nursing, Pondy Cuddalore main road, Kirumampakkam

Pondicherry
PONDICHERRY
607402
India 
Phone  09486199264  
Fax    
Email  sasi.v@vmcnpdy.edu.in  
 
Source of Monetary or Material Support  
Vinayaka Missions Research Foundation Deemed to be University, NH-47, Sankari main road, Ariyanoor, Salem, Tamilnadu, India- 636308 
 
Primary Sponsor  
Name  Vinayaka Missions Research Foundation Deemed to be University 
Address  NH-47, Sankari Main Road, Ariyanoor, Salem, Tamil Nadu 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Mrs Alby Johnson  Government Head Quarters Hospital  Department of Obstetrics and Gynaecology,Hospital Rd, Manjakuppam, Cuddalore
Cuddalore
TAMIL NADU 		 7600989396

albyp123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Vinayaka Missions College of Nursing  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O132||Gestational [pregnancy-induced] hypertension without significant proteinuria, second trimester, (2) ICD-10 Condition: O140||Mild to moderate pre-eclampsia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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 morbidity and improve patient outcomes. The bundle comprises 1. regular monitoring (blood pressure, weight gain, clinical parameters, medication adherence, presenting symptoms for pregnancy-induced hypertension, anxiety and Biomarkers for pregnancy-induced hypertension) at every antenatal visit- 20 minutes 2. education & counselling on maternal safety (overview on maternal safety, pregnancy-induced hypertension, diet for pregnancy-induced hypertension, anxiety in pregnancy), exercises in pregnancy and regular follow-up for compliance - 15 minutes 
Comparator Agent  Routine care  Consultation, regular monitoring, symptoms of PIH and anxiety and follow up in antenatal visit. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  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. 
 
ExclusionCriteria 
Details  antenatal mothers with high-risk conditions like chronic hypertension, gestational diabetes mellitus, placenta previa, multiple pregnancy and chronic diseases. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
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 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  
Outcome  TimePoints 
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
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 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/09/2022 
Date of Study Completion (India) 15/05/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 1. “Peripartum Safety: Time to Act”. Indian Journal of Public Health Research & Development, vol. 12, no. 2, Mar. 2021, pp. 12-16, https://doi.org/10.37506/ijphrd.v12i2.14088. 2. Johnson A, Vaithilingan S, Avudaiappan SL. The Interplay of Hypertension and Anemia on Pregnancy Outcomes. Cureus. 2023 Oct 2;15(10):e46390. doi: 10.7759/cureus.46390. PMID: 37927714; PMCID: PMC10620472. 3. Johnson A, Vaithilingan S, Ragunathan L. Quantifying the Occurrence of High-Risk Pregnancy: A Comprehensive Survey. Cureus. 2024 Apr 26;16(4):e59040. doi: 10.7759/cureus.59040. PMID: 38800298; PMCID: PMC11128061. 4. Johnson A, Vaithilingan S, Ragunathan L. Association of obesity and overweight with the risk of preeclampsia in pregnant women: an observational cohort study. Irish Journal of Medical Science (1971-). 2024 Aug 19:1-7. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary    Maternal safety refers to the safe care of women given during antenatal, intranatal and postnatal periods. The health outcome of pregnant women lies in the hands of health care providers. Hypertensive disorders during pregnancy are the most common cause of mortality and have an increased risk of obstetric complications. Anxiety during pregnancy increase the likelihood of pregnancy-induced hypertension. Therefore, there is an urgent need for new and different methods of treating hypertension during pregnancy, particularly non-pharmacological options.  
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