- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07829822
Exploring Reproductive Decision-Making Among Women With Multiple Sclerosis
Exploring Reproductive Decision-Making Among Women With Multiple Sclerosis in Assiut Governorate: Mixed-Methods Study
Multiple sclerosis (MS) is a chronic disease that mainly affects young adults, including women during their reproductive years. Women with MS may face important questions and concerns related to marriage, fertility, pregnancy, childbirth, breastfeeding, motherhood, and family planning. These decisions may be influenced by concerns about MS symptoms and disability, pregnancy-related changes in the disease, medications, possible effects on the baby, and the availability of appropriate reproductive health counseling and support.
This study aims to explore reproductive decision-making among women of reproductive age living with multiple sclerosis in Assiut Governorate, Egypt. The study will examine their experiences, concerns, fertility intentions, childbearing preferences, family planning practices, and experiences related to marriage, pregnancy, breastfeeding, and motherhood. It will also assess factors that may influence reproductive decisions, including disease-related characteristics, social and demographic factors, reproductive autonomy, and partner support among married women.
The study will use a sequential explanatory mixed-methods design. The quantitative component will include eligible married women with multiple sclerosis attending selected multiple sclerosis clinics in Assiut Governorate. Information will be collected through face-to-face interviews using structured questionnaires and validated assessment tools. The quantitative findings will be used to identify important patterns and factors associated with reproductive decision-making.
A qualitative component will then be conducted through in-depth interviews with selected women with multiple sclerosis to provide a deeper understanding of their experiences and concerns. Single women will be explored qualitatively to understand their perspectives regarding marriage, fertility, and future reproductive plans, while married women who participate in the quantitative component may also be invited for qualitative interviews. Participants will be selected to obtain a range of experiences and characteristics, and interviews will continue until sufficient information is obtained.
The study will provide a better understanding of the reproductive needs and concerns of women living with multiple sclerosis in Assiut Governorate. The findings may help identify gaps in reproductive health counseling and support and may contribute to the development of more patient-centered reproductive health services for women with multiple sclerosis
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease of the central nervous system that predominantly affects individuals during their reproductive years. The increasing availability of effective disease-modifying therapies and improvements in the management of MS have allowed many women living with MS to consider marriage, pregnancy, and parenthood. However, reproductive decision-making may remain complex because women may have concerns about disease progression, disability, pregnancy and postpartum disease activity, effects of medications on pregnancy and breastfeeding, possible health risks to the child, and their ability to fulfil maternal and family responsibilities.
Reproductive decisions among women with MS may also be influenced by factors beyond the clinical characteristics of the disease. These may include age, marital status, educational and socioeconomic circumstances, family and social expectations, partner support, reproductive autonomy, previous reproductive experiences, access to appropriate counseling, and perceptions of the impact of MS on family life. Women may therefore make reproductive decisions within a complex interaction of medical, psychological, interpersonal, social, and demographic factors.
Despite the importance of reproductive health in women with chronic diseases, there is limited information about how women with MS in Egypt experience and make reproductive decisions, particularly within the social and cultural context of Upper Egypt. Understanding women's perspectives is important for identifying unmet reproductive health needs and improving counseling and support provided by healthcare professionals.
This study will use a sequential explanatory mixed-methods approach to explore reproductive decision-making among women of reproductive age living with MS in Assiut Governorate. The study will initially collect quantitative information from eligible married women with MS. The quantitative component will assess reproductive decision-making and related factors, including reproductive intentions and preferences, reproductive autonomy, partner support, and relevant sociodemographic and disease-related characteristics.
The quantitative findings will subsequently inform the qualitative component. In-depth interviews will be conducted with selected women with MS to provide a deeper understanding of the experiences, concerns, perceptions, and contextual factors underlying reproductive decisions. Married women participating in the quantitative component may be invited to participate in the qualitative interviews. Single women will be explored separately through the qualitative component to capture their perspectives regarding marriage, fertility intentions, future childbearing, and concerns related to reproductive life that cannot be adequately assessed through the quantitative component.
The qualitative sampling will use purposive maximum-variation sampling to include women with diverse sociodemographic, marital, and disease-related characteristics. These may include age, residence, educational level, employment, disease duration, disability severity, disease-modifying treatment, fertility intentions, motherhood status, and pregnancy experience after MS diagnosis. Interviews will continue until sufficient depth and diversity of information are achieved and thematic saturation is reached.
The qualitative interviews will explore women's experiences of living with MS and its perceived influence on marriage and intimate relationships, fertility intentions and timing of childbearing, desired family size, pregnancy and childbirth, breastfeeding, motherhood and childcare, and family planning and contraceptive decision-making. Participants will also be asked about their experiences of receiving reproductive health counseling and information related to pregnancy, contraception, breastfeeding, MS treatment, and potential risks to themselves or their children. The interviews will further explore the roles of partners, families, healthcare professionals, and the broader social context in shaping reproductive decisions.
Quantitative and qualitative findings will be interpreted together to develop a comprehensive understanding of reproductive decision-making among women living with MS. The qualitative findings will help explain and contextualize important quantitative patterns and may identify experiences or factors that are not captured by structured questionnaires.
The study is intended to generate evidence about the reproductive concerns, needs, and decision-making experiences of women living with MS in Assiut Governorate. The findings may help identify gaps in reproductive health information and counseling and may support the development of more responsive, patient-centered reproductive health services for women with MS. The study may also provide a basis for future research and interventions addressing reproductive health and family planning needs among women living with chronic neurological diseases.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Doneez Amir Eskander
- Numéro de téléphone: +201220225678
- E-mail: doneez.amir@aun.edu.eg
Sauvegarde des contacts de l'étude
- Nom: Doaa Mohamed Osman, assistant professor
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
The quantitative study population will include married women aged 18-49 with confirmed multiple sclerosis who attend the selected study sites during the study period. On the other hand, the qualitative population will include single, currently married, divorced and widowed/ever-married women aged 18-49 years with confirmed MS, as appropriate to the study sites and the qualitative sampling plan.
La description
o Inclusion criteria
Women who are:
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Within reproductive age group (18-49 years).
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With confirmed diagnosis of multiple sclerosis according to the 2024 Revised McDonald Criteria (31).
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Able to communicate, agree to participate in the study and provide informed consent.
- Exclusion Criteria
Women with:
- Severe cognitive impairment or psychiatric illness affects their ability to participate in the study.
- Acute medical or neurological deterioration at the time of recruitment makes participation inappropriate or burdensome.
- Any condition judged by the clinical team or research team to make participation unsafe or to compromise the validity of the interview.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: OTHER
- Perspectives temporelles: CROSS_SECTIONAL
Cohortes et interventions
Groupe / Cohorte |
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The quantitative study population will include married women aged 18-49 with confirmed MS
The quantitative study population will include married women aged 18-49 with confirmed multiple sclerosis who attend the selected study sites during the study period. On the other hand, the qualitative population will include single, currently married, divorced, or widowed/ever-married women aged 18-49 years with confirmed MS, as appropriate to the study sites and the qualitative sampling plan. Eligibility criteria:
Women with:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Motherhood/Pregnancy Choice and Worries Questionnaire (MPWQ) score
Délai: At baseline (during the study interview)
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The Motherhood/Pregnancy Choice and Worries Questionnaire (MPWQ) will be used to assess women's experiences, choices, and worries related to motherhood and pregnancy in the context of multiple sclerosis, including concerns about pregnancy, motherhood, fertility, breastfeeding, childcare, and the potential effects of MS on reproductive decisions. The outcome will be reported as the total MPWQ score according to the scoring instructions of the instrument. The minimum and maximum possible scores and the direction of interpretation will be reported according to the validated version used in this study. |
At baseline (during the study interview)
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Reproductive Concerns Scale score
Délai: At baseline (during the study interview)
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The Reproductive Concerns Scale will be used to assess reproductive concerns related to multiple sclerosis, including concerns about fertility, pregnancy, maternal and fetal health, disease-related risks, treatment-related reproductive issues, and future reproductive plans. The outcome will be reported as the total Reproductive Concerns Scale score according to the scoring instructions of the instrument. The minimum and maximum possible scores and the direction of interpretation will be reported according to the validated version used in this study. |
At baseline (during the study interview)
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Prof. Dr. Etemad El-shereef, professor, Assiut University
Publications et liens utiles
Publications générales
- Walton C, King R, Rechtman L, Kaye W, Leray E, Marrie RA, Robertson N, La Rocca N, Uitdehaag B, van der Mei I, Wallin M, Helme A, Angood Napier C, Rijke N, Baneke P. Rising prevalence of multiple sclerosis worldwide: Insights from the Atlas of MS, third edition. Mult Scler. 2020 Dec;26(14):1816-1821. doi: 10.1177/1352458520970841. Epub 2020 Nov 11.
- Wang Y, Wang J, Feng J. Multiple sclerosis and pregnancy: Pathogenesis, influencing factors, and treatment options. Autoimmun Rev. 2023 Nov;22(11):103449. doi: 10.1016/j.autrev.2023.103449. Epub 2023 Sep 21.
- Krzystanek E, Geszka P, Gawin M, Fabian M, Forys A, Lasek-Bal A. The Knowledge About the Impact of Multiple Sclerosis on Pregnancy and Maternity Among Patients with Multiple Sclerosis. J Clin Med. 2026 Jun 14;15(12):4625. doi: 10.3390/jcm15124625.
- Pourhaji F, Taraghdar MM, Peyman N, Jamali J, Tehrani H. Explaining the burden of cultural factors on MS disease: a qualitative study of the experiences of women with multiple sclerosis. BMC Womens Health. 2024 Aug 30;24(1):477. doi: 10.1186/s12905-024-03328-0.
- Hernandez-Ledesma AL, Rodriguez-Mendez AJ, Gallardo-Vidal LS, Trejo-Cruz G, Garcia-Solis P, Davila-Esquivel FJ. Coping strategies and quality of life in Mexican multiple sclerosis patients: Physical, psychological and social factors relationship. Mult Scler Relat Disord. 2018 Oct;25:122-127. doi: 10.1016/j.msard.2018.06.001. Epub 2018 Jun 26.
- Boutitah-Benyaich I, Eixarch H, Villacieros-Alvarez J, Hervera A, Cobo-Calvo A, Montalban X, Espejo C. Multiple sclerosis: molecular pathogenesis and therapeutic intervention. Signal Transduct Target Ther. 2025 Oct 2;10(1):324. doi: 10.1038/s41392-025-02415-4.
- Krysko KM, Graves JS, Dobson R, Altintas A, Amato MP, Bernard J, Bonavita S, Bove R, Cavalla P, Clerico M, Corona T, Doshi A, Fragoso Y, Jacobs D, Jokubaitis V, Landi D, Llamosa G, Longbrake EE, Maillart E, Marta M, Midaglia L, Shah S, Tintore M, van der Walt A, Voskuhl R, Wang Y, Zabad RK, Zeydan B, Houtchens M, Hellwig K. Sex effects across the lifespan in women with multiple sclerosis. Ther Adv Neurol Disord. 2020 Jul 1;13:1756286420936166. doi: 10.1177/1756286420936166. eCollection 2020.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Reproductive Decision-Making
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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