Development and Psychometric Evaluation of the Need Assessment Tool for Women with the Experience of Pregnancy Termination Due to Fetal Anomalies: Protocol for a Mixed Methods Study

Introduction: Fetal anomalies, especially when results in pregnancy termination, is a great challenge for pregnant women. Pregnancy termination can have a great physical, mental and social impact on women and their families. The aim of the present study is to explain the experience of women who underwent pregnancy termination due to fetal anomalies and to develop and assess the psychometric properties of a specific tool to assess the needs of these women.

Materials and Methods: This protocol study has a sequential exploratory mixed methods design. The first phase is a qualitative study based on purposeful sampling among women with the experience of pregnancy termination due to fetal anomalies and their spouses, midwives, gynecologists and forensic medicine specialists in Rasht, Iran. Data collection will be performed based on semi-structured interviews and record field notes. Data will be analyzed simultaneously using qualitative content analysis method. The draft of the need assessment of women with the experience of pregnancy termination due to fetal anomalies questionnaire will be prepared based on the findings of the first phase as well as literature review. The questionnaire will then be finalized based on evaluations in an expert panel. The face and content validity as well as reliability of the questionnaire will be performed after generating questionnaire items. Construct validity will be assessed using the exploratory factor analysis through a descriptive cross-sectional study on women with the experience of pregnancy termination due to fetal anomalies. Sample size will be calculated based on the required sample size for factor analysis for identifying the factors of the questionnaire. Therefore data will be collected from health and treatment centers based on convenience sampling. Data will be analyzed using descriptive and inferential statistics.

Conclusion: The developed questionnaire in this mixed methods study can be used in the interventions, supporting and curative programs for women with the experience of pregnancy termination due to fetal anomalies.