Exploring Reproductive Decision-Making Among Women With Multiple Sclerosis

NCT07829822 | Not Yet Recruiting DMC

• 1 other identifier: Reproductive Decision-Making
• Study Type: observational
• Target: 272
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• Motherhood/Pregnancy Choice and Worries Questionnaire (MPWQ) score

  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)

• Reproductive Concerns Scale score

  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)

Study Arms (1)

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: * Inclusion criteria Women who are * Within the reproduct age group (18-49 years). * With a confirm diagnosis of multiple sclerosis according to the 2024 Revised McDonald Criteria (31). * 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

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• Women who are:
• Within reproductive age group (18-49 years).
• With confirmed diagnosis of multiple sclerosis according to the 2024 Revised McDonald Criteria (31).
• Able to communicate, agree to participate in the study and provide informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (7)

• 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.

  PMID: 42355793 BACKGROUND

• 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.

  PMID: 39210329 BACKGROUND

• 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.

  PMID: 30071505 BACKGROUND

• 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.

  PMID: 37741528 BACKGROUND

• 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.

  PMID: 33174475 BACKGROUND

• 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.

  PMID: 41034190 BACKGROUND

• 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.

  PMID: 32655689 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Prof. Dr. Etemad El-shereef, professor

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Doneez Amir Eskander

CONTACT

+201220225678; doneez.amir@aun.edu.eg

Doaa Mohamed Osman, assistant professor

CONTACT

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 21, 2026
• Study Start (Estimated): June 1, 2027
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2031
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share