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CTRI Number  CTRI/2024/02/062494 [Registered on: 09/02/2024] Trial Registered Prospectively
Last Modified On: 05/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Understanding how pregnant women feel about their care at a teaching hospital involves asking them about their experiences. This helps find ways to make the care better, like improving communication and accessibility based on their feedback. 
Scientific Title of Study   Exploring patient reported experience measure in prenatal care of tertiary teaching hospital. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Neeru Yadav 
Designation  Masters in Hospital Administration Student 
Affiliation  Prasanna School of Public Health  
Address  Department of Social and Health Innovation, Prasanna School of Public Health, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9802579999  
Fax    
Email  neeru.psphmpl2022@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Brayal DSouza 
Designation  Associate Professor, Quality Management Representative 
Affiliation  Prasanna School of Public Health 
Address  Department of Social and Health Innovation, Prasanna School of Public Health, MAHE, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  9900405393  
Fax    
Email  brayal.dsouza@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Swathi K S  
Designation  Associate Professor  
Affiliation  Prasanna School of Public Health 
Address  Department of Social and Health Innovation, Prasanna School of Public Health, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9481749911  
Fax    
Email  swathi.ks@manipal.edu  
 
Source of Monetary or Material Support  
LH3, Department of Social and Health Innovation, Prasanna School Of Public Health, MAHE, Manipal, Udupi, Karnataka,576104 
 
Primary Sponsor  
Name  Dr Neeru Yadav  
Address  Prasanna school of Public Health, MAHE, Manipal, Udupi, Karnataka, India  
Type of Sponsor  Other [Self] 
 
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 
Dr Brayal Dsouza  Kasturba Hospital, Manipal  Department of Obstetrics and Gynaecology, Room No,- 28,Ground floor, Women and Children Block
Udupi
KARNATAKA 
9900405393

brayal.dsouza@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2(Student Research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  NOT APPLICABLE 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  49.00 Year(s)
Gender  Female 
Details  Women less than one year of postpartum.
Women who are willing to participate. 
 
ExclusionCriteria 
Details  Women not willing to participate. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To analyze experiences and overall satisfaction of post-partum women in prenatal care of tertiary teaching hospital.  8 Weeks  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="332"
Sample Size from India="332" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/02/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

1. Title of the project:  

          Exploring patient reported experience measure in prenatal care of tertiary teaching hospital.

2. Type of Study:  Prospective Study

3. Aims & objectives:

Aim

The aim of this study is to assess how satisfied pregnant women are with the care they receive at the hospital during prenatal visits.

Objectives

1.      To measure PREM of prenatal care experience  among tertiary teaching care hospital.

2.      To identify areas of improvement of PREM labels.

4.Justification for study (whether of national significance with rationale):

PREMs are crucial for evaluating the patient’s experiences and identifying areas for healthcare improvement. Regular measurement of PREMs enables a comprehensive assessment of care quality, optimizes disease management, and meets patient needs. Prenatal care is a critical aspect of maternal and child health. Researching patient experiences in this context can generate valuable insights for academic institutions, healthcare professionals and researchers interested in improving prenatal care practices. Through patient feedback, healthcare providers can improve communication with pregnant individuals. Effective communication can lead to better informed decisions and a more positive care experience.

Also, inviting patients to provide feedback through PREMs surveys can empower them to take an active role in their care.

Overall, exploring PREMs in prenatal care at a tertiary teaching hospital is a multifaceted approach that benefits patients, healthcare providers, and the healthcare system by improving care quality, patient satisfaction and the overall healthcare experience.

 

5. Departments involved: Department of gynecology and obstetrics

 

6. Study period:  The study will commence immediately upon receiving Institutional Ethics Committee (IEC) approval. The study is planned to start from October 2023 and to be completed by 30th April 2024, with the last date of data collection and analysis set as 30th April 2024.

7. Sample size : 332

 

8. Materials and methods:   

            A) Inclusion and exclusion criteria:

a) Inclusion:  I) Women less than one year of postpartum. 

                        II) Women who are willing to participate.

   b) Exclusion: I) Women not willing to participate.

            B) Biological materials required (type - blood, tissue etc. and quantity): nil

           

            C) Statistical methods: Descriptive statistics and inferential statistics

 

            D) Tools used: Data will be collected using a validated questionnaire of person-centered maternity care (PCMC) which has open access.

 

9. Detailed description of procedure / processes:  

 A survey would be conducted using validated questionnaire of PCMC from study validation person centered maternity care scale in India which has open access.

Respondent will be postpartum women aged 15 to 49 with less than one year of postpartum. Eligible women will be identified. The survey will be conducted in English as well as Kannada language.

All participants will be provided with written informed consent after receiving information about the research.

Each questionnaire would reflect responses ranging from 0 to 3, 0 as the lowest level to 3 as the highest level.

After the data collection is done from the survey, the data would be analyzed using SPSS software.

The PCMC scale is composed of 3 subscales: dignity and respect (6 items), communication and autonomy (9 items), and supportive care (12 items). Responses ranged from 0 (“No, never”) Yes, a few times – 1 Yes, most of the time – 2 to 3 (“Yes, all the time”) Negatively worded items were reverse coded, and responses were totaled across all 27 items to obtain a total PCMC score from 0 to 81.

Higher scores indicated better PCMC. In addition, total scores were calculated for each subscale, ranging from 0 to 18 for dignity and respect, 0 to 27 for communication and autonomy, and 0 to 36 for supportive care.

 Furthermore, categorical variables were created, classifying total PCMC and subscale scores as “low,” “medium,” or “high,” with scores in the lower 25th i.e., 22.25 and upper 75th percentiles i.e., 64.75 being defined as “low” and “high,” respectively.

Characteristics of respondents would be presented using frequency and percentages.

Mean PCMC scores and Standard deviation would be calculated and compared across various independent variables such as sociodemographic characteristics of the respondents e.g., age, education, marital status, insurance coverage, domicile status(urban/rural), occupation status and time of start of antenatal care using t-tests and analysis of variance (ANOVA).

We will use Pearson correlation to test association of total PCMC score with overall satisfaction from maternity care.

Interpret the results, draw conclusions and report the findings: Summarize the main findings, draw conclusions based on the analysis, and report the results in a clear and concise manner. Analyze the findings and interpret the results. Discuss limitations and further considerations.

10. Outcome measures:  

To analyze experiences and overall satisfaction of post-partum women in prenatal care of tertiary teaching hospital.

 

11. Potential risks and benefits :

Potential risks: This study is of minimal risk as it is survey based. Hence minimal discomfort could be there in taking time to answer the questionnaire.

 

Benefits:                                                                                                                                                                                                                        I. PREM are valuable tools in knowing the patient experiences in improving service delivery.

II. Helps hospital improve patient satisfaction by making use of inputs provided by patients.                                                                                                                                                                                                                    

12. Eethical considerations and methods to address issues:

Informed consent of the participant will be taken, and participant is made aware of participant information sheet which mentions all the details related to study and frequently asked questions by the participants are all addressed in the patient information sheet.

 

13. Budget (give details) and proposed funding source: Nil

 

14. Review of literature (within 1000 words):  

Daniel C Ogbuabor,2019 this study focused on validating PCMC scale and investigating post-partum women’s perceptions of PCMC in Enugu state, Nigeria. According to this woman who married at different ages, employment status, participation in decision making, place of delivery and pregnancy complications all influenced the level of PCMC received. The study’s findings highlight the need for improvements in PCMC within Enugu state and highlight key areas for intervention.

Elizabeth K Stierman,2023This study examines person-centered maternity care in Ethiopia, emphasizing the importance of effective communication, respect, and emotional support during childbirth. It employs a validated scale to assess the quality of care experienced by postpartum women in six regions of Ethiopia.  A significant portion of women reported not being asked for permission before medical procedures, and explanations for these procedures were lacking. This highlights a crucial need for healthcare providers to enhance patient-provider communication and involve women in decision-making during childbirth.

 

Socioeconomic factors, such as wealth and education, were associated with higher person-centered maternity care scores, underlining the role of social determinants in shaping childbirth experiences.

Fen taw Teshome,2022 This study conducted in South Wollo Zone public hospitals in Ethiopia sheds light on the state of person-centered maternity care. It emphasizes that globally, insufficient attention has been paid to addressing abuse and disrespect in maternity care.

 

The research findings reveal a concerning gap in person-centered maternity care, with an overall score of only 64%. While the sub-scales for dignity and respect fared better at 81.9%, communication and autonomy (56.4%) and supportive care (61.6%) showed notable deficiencies. Qualitative insights from interviews pointed to infrastructure and resource limitations within government hospitals, which likely contributed to the suboptimal care experienced by mothers.

 

The study underscores the urgent need for health sector improvements, particularly in terms of enhancing communication between healthcare providers and clients and creating a more supportive environment within healthcare facilities.

May Sudhinaraset,2021 This study provides insights into the impact of person-centered maternity care on maternal and newborn health outcomes.

 

The findings highlight the importance of person-centered maternity care in reducing the risk of maternal complications, postpartum depression, and newborn complications. Moreover, the study highlights that higher scores in the supportive care subscale are particularly effective in decreasing the risk of complications for both mothers and newborns.

 

Overall, these results emphasize the potential for enhancing maternal and newborn health outcomes through investments in improving the quality of care provided during childbirth, with a specific focus on dignified and respectful treatment, effective communication, and support for women’s autonomy.

Lyzette T ,2022 This mixed-methods prospective cohort study in the Netherlands explores the experiences of women in completing and discussing patient-reported outcome measures (PROM) and patient-reported experience measures (PREM) related to pregnancy and childbirth. The study involved women who received these questionnaires as part of routine perinatal care. The findings indicate that more than half of the participants felt the need to discuss the questionnaire outcomes with their healthcare providers. Overall, women found the questionnaires acceptable and useful for symptom detection and personalized care up to six months postpartum. The study highlights the importance of tailoring care based on these outcomes and identifies facilitators such as increased awareness of health status.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

15. References:

1. Ogbuabor DC, Nwankwor C. Perception of person-centred maternity care and its associated factors among post-partum women: Evidence from a cross-sectional study in Enugu State, Nigeria. Int J Public Health [Internet]. 2021;66. Available from: http://dx.doi.org/10.3389/ijph.2021.612894

2. Stierman EK, Zimmerman LA, Shiferaw S, Seme A, Ahmed S, Creanga AA. Understanding variation in person-centered maternity care: Results from a household survey of postpartum women in 6 regions of Ethiopia. AJOG Glob Rep [Internet]. 2023;3(1):100140. Available from: http://dx.doi.org/10.1016/j.xagr.2022.100140

3. Dagnaw FT, Kehali KY, Agago TA, Hailemeskel HS. Person-centered maternity care among mothers who gave birth in South Wollo Zone public hospitals, Northeastern Ethiopia: A mixed-method study. Health Serv Insights [Internet]. 2022; 15:117863292211279. Available from: http://dx.doi.org/10.1177/11786329221127946

4. Sudhinaraset M, Landrian A, Golub GM, Cotter SY, Afulani PA. Person-centered maternity care and postnatal health: associations with maternal and newborn health outcomes. AJOG Glob Rep [Internet]. 2021;1(1):100005. Available from: http://dx.doi.org/10.1016/j.xagr.2021.100005

5. Laureij LT, Depla AL, Kariman SS, Lamain-de Ruiter M, Ernst -Smelt HE, Hazelzet JA, et al. Women’s experiences with using patient-reported outcome and experience measures in routine perinatal care in the Netherlands: a mixed-methods study. BMJ Open [Internet]. 2023;13(3): e064452. Available from: http://dx.doi.org/10.1136/bmjopen-2022-064452

 

 

 
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