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Demographic Characteristics, Health Outcomes, and Complications of Subdermal Contraceptive Implant Use Among Sudanese Women

ETH-20260304-0134 تاريخ التقديم: Mar 04, 2026 / Submitted: Mar 04, 2026
قيمة الرسوم / Payment Amount
21,000.00 SDG
نوع البحث / Research Type
ورقة علمية / Research Paper
فترة الدراسة / Study Period
Mar 09, 2026 - May 06, 2026
Approved
السودان - الولاية الشمالية
وزارة الصحة
الادارة العامة للتخطيط والتنمية الصحية
إدارة البحوث
لجنة الموافقة الأخلاقية
طلب الموافقة الأخلاقية - Ethical Approval Request Form
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Ethical Approval Request Form
General Administration for Planning and Health Development
Research Department
Ethical Approval Committee
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رقم التسلسل
Serial Number
SER-20260304-0134
رقم الطلب
Request Number
ETH-20260304-0134
تاريخ تقديم الطلب
Date of Submission
2026-03-04

القسم الأول: معلومات الباحث / Principal Investigator Information

1. الاسم الكامل للباحث الرئيسي
Principal Investigator Full Name
Thoraya Salah Murtada Sidahmed
2. الجهة التي ينتمي إليها
Affiliation Type
جامعة / University: Alzaiem Alazhary University - Faculty of Medicine
Alzaiem Alazhary University - Faculty of Medicine
3. الوظيفة / اللقب العلمي
Job Title/Academic Degree
-
4. البريد الإلكتروني
Email Address
thorayagzzar@gmail.com
5. رقم الهاتف
Phone Number
-
المشرف / Supervisor
الاسم الكامل / Full Name
Mustafa Mohammed
البريد الإلكتروني / Email
-
الوظيفة / اللقب العلمي / Job Title
-
رقم الهاتف / Phone
-
القسم / المؤسسة / Department
-

القسم الثاني: تفاصيل الدراسة البحثية / Research Study Details

7. عنوان الدراسة
Study Title
Demographic Characteristics, Health Outcomes, and Complications of Subdermal Contraceptive Implant Use Among Sudanese Women
8. نوع البحث (يرجى التحديد)
Type of Research (Please select)
☐دكتوراه / PhD
☐ماجستير / Master's
☐بكالوريوس / Bachelor's
☐دبلوم عالي / Postgraduate Diploma
☐دبلوم وسيط / Intermediate Diploma
☑ورقة علمية / Research Paper
☐تقرير علمي / Scientific Report
☐أبحاث طبية / Medical Research
☐أخرى / Other
9. وصف مختصر للبحث
Brief Description of Research
Background Subdermal contraceptive implants (SCI) are highly effective long-acting reversible contraceptives, offering reliable pregnancy prevention. However, they may cause side effects, such as menstrual changes, hormonal effects, and local reactions, which can affect satisfaction and continuation. In Sudan, limited access to modern contraceptives and variable family planning services make it important to understand the demographic and health impacts of SCI use to improve uptake, satisfaction, and program effectiveness. Objectives Primary Objective: • Assess health outcomes and complications associated with SCI use among Sudanese women in Northern Sudan. Secondary Objectives: 1. Describe the demographic and reproductive characteristics of SCI users. 2. Determine the frequency and types of complications experienced. 3. Examine associations between complications and factors such as age, region, and reproductive history. 4. Evaluate user satisfaction and reasons for SCI removal or discontinuation. Methods and Materials Study Design and Setting A cross-sectional study will be conducted in family planning centers in Northern Sudan. Study Population and Sampling • Population: Women who have received an SCI at participating centers. • Sample Size: 700 women recruited using purposive sampling to ensure diverse representation. • Inclusion Criteria: Received an SCI and available for follow-up. • Exclusion Criteria: Incomplete records or inability to participate in interviews. Data Collection • Medical Record Review: Demographics, reproductive history, SCI use, removal, and documented complications. • Phone Interviews: Experiences, satisfaction, and unrecorded complications. Variables Assessed • Demographics: age, residence, living situation • Reproductive history: parity, inter-pregnancy interval • SCI outcomes: duration of use, removal reasons, complications, psychological effects Data Analysis • Descriptive statistics: frequencies, percentages • Inferential analyses: chi-square, odds ratios (OR), relative risks (RR), 95% confidence intervals (CI) • Significance: p < 0.05 • Software: Jamovi 2.3 Ethical Considerations • Informed consent will be obtained from all participants during phone interviews. • Participation is voluntary, and participants can withdraw at any time without affecting care. • Confidentiality will be maintained using unique codes, with data stored securely and accessible only to the research team.

القسم الثالث: الجوانب الأخلاقية / Ethical Considerations

10. طريقة الحصول على الموافقة من المشاركين
Method of Obtaining Consent from Participants
☐مكتوبة / Written
☑شفهية / Verbal
☐غير مطبقة / Not Applicable
☐ضمنية / Implied
☐إعفاء / Waiver
يرجى إرفاق نموذج الموافقة / Please attach consent form
11. آلية الحفاظ على سرية المعلومات
Confidentiality Measures
All participants will be provided with clear information about the study’s purpose, procedures, potential risks and benefits, and their rights. Consent will be obtained during phone interviews, verbally or in writing depending on literacy levels. Participation is voluntary, and women can withdraw at any time without any effect on their access to healthcare.
12. مدى المخاطر على المشاركين
Risk Level to Participants
☐لا توجد / None
☑طفيفة / Minor
☐متوسطة / Moderate
☐عالية / High
يرجى توضيح أي مخاطر محتملة وخطة التعامل معها / Please describe any potential risks and mitigation:
-
13. الفوائد المحتملة للمشاركين أو المجتمع
Potential Benefits to Participants or Society
Provides evidence to guide family planning programs on improving SCI service delivery and quality across different regions of Sudan. • Supports development of strategies for monitoring and managing SCI side effects, improving efficiency in resource allocation at family planning centers.
14. هل تشمل الدراسة فئات ضعيفة؟
Does the study involve vulnerable groups?
☐الأطفال / Children
☐النساء الحوامل / Pregnant Women
☐اللاجئون/النازحون / Refugees/Displaced
☐ذوو الإعاقة / People with Disabilities
☐أخرى / Other:

القسم الرابع: قائمة المرفقات المطلوبة / Required Attachments

نسخة من المقترح البحثي الكامل
Full Research Proposal
أدوات جمع البيانات
Data Collection Tools
خطاب تسهيل من الجامعة
University Facilitation Letter

القسم الخامس: الإقرار والتوقيع / Acknowledgment and Signature

أُقر أنا الموقع أدناه بأن جميع المعلومات الواردة في هذه الاستمارة صحيحة وكاملة، وأتعهد بعدم البدء في أي جزء من الدراسة قبل الحصول على الموافقة الأخلاقية الرسمية، والالتزام بجميع الإرشادات والمعايير الأخلاقية المعتمدة من قبل لجنة الموافقة الأخلاقية.
I, the undersigned, acknowledge that all information provided in this form is accurate and complete, and I agree not to begin any part of the study before receiving official ethical approval, and to comply with all ethical guidelines and standards approved by the Ethical Approval Committee.
اسم الباحث الرئيسي / Principal Investigator Name
Thoraya Salah Murtada Sidahmed
التوقيع / Signature
_______________________
التاريخ / Date
2026-03-04

معلومات الباحث / Researcher Information

T

Thoraya Salah Murtada Sidahmed

thorayagzzar@gmail.com

جامعة: Alzaiem Alazhary University الكلية: Faculty of Medicine

Dongola Specialized Hospital

اسم المؤسسة التي سيتم فيها عمل البحث / Name of the institution where the research will be conducted

معلومات الدراسة / Study Information

ورقة علمية / Research Paper

messages.degree_research_paper - messages.degree_research_paper

21,000.00 SDG

Background Subdermal contraceptive implants (SCI) are highly effective long-acting reversible contraceptives, offering reliable pregnancy prevention. However, they may cause side effects, such as menstrual changes, hormonal effects, and local reactions, which can affect satisfaction and continuation. In Sudan, limited access to modern contraceptives and variable family planning services make it important to understand the demographic and health impacts of SCI use to improve uptake, satisfaction, and program effectiveness. Objectives Primary Objective: • Assess health outcomes and complications associated with SCI use among Sudanese women in Northern Sudan. Secondary Objectives: 1. Describe the demographic and reproductive characteristics of SCI users. 2. Determine the frequency and types of complications experienced. 3. Examine associations between complications and factors such as age, region, and reproductive history. 4. Evaluate user satisfaction and reasons for SCI removal or discontinuation. Methods and Materials Study Design and Setting A cross-sectional study will be conducted in family planning centers in Northern Sudan. Study Population and Sampling • Population: Women who have received an SCI at participating centers. • Sample Size: 700 women recruited using purposive sampling to ensure diverse representation. • Inclusion Criteria: Received an SCI and available for follow-up. • Exclusion Criteria: Incomplete records or inability to participate in interviews. Data Collection • Medical Record Review: Demographics, reproductive history, SCI use, removal, and documented complications. • Phone Interviews: Experiences, satisfaction, and unrecorded complications. Variables Assessed • Demographics: age, residence, living situation • Reproductive history: parity, inter-pregnancy interval • SCI outcomes: duration of use, removal reasons, complications, psychological effects Data Analysis • Descriptive statistics: frequencies, percentages • Inferential analyses: chi-square, odds ratios (OR), relative risks (RR), 95% confidence intervals (CI) • Significance: p < 0.05 • Software: Jamovi 2.3 Ethical Considerations • Informed consent will be obtained from all participants during phone interviews. • Participation is voluntary, and participants can withdraw at any time without affecting care. • Confidentiality will be maintained using unique codes, with data stored securely and accessible only to the research team.

Mar 09, 2026 - May 06, 2026

Mar 11, 2026 - Apr 02, 2026

الاعتبارات الأخلاقية / Ethical Considerations

Verbal

مخاطر منخفضة - Low Risk

All participants will be provided with clear information about the study’s purpose, procedures, potential risks and benefits, and their rights. Consent will be obtained during phone interviews, verbally or in writing depending on literacy levels. Participation is voluntary, and women can withdraw at any time without any effect on their access to healthcare.

Provides evidence to guide family planning programs on improving SCI service delivery and quality across different regions of Sudan. • Supports development of strategies for monitoring and managing SCI side effects, improving efficiency in resource allocation at family planning centers.