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Maternal and Socioeconomic Determinants of Mid-Trimester Pregnancy Complications

ETH-20260304-0133 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-20260304-0133
رقم الطلب
Request Number
ETH-20260304-0133
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
Maternal and Socioeconomic Determinants of Mid-Trimester Pregnancy Complications
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: Pregnancy-related complications are a major public health challenge worldwide, particularly in low- and lower-middle-income countries. Sub-Saharan Africa carries the highest burden, with maternal mortality ratios exceeding the global average by more than twofold. Sudan has historically faced high maternal mortality, and the armed conflict that began in April 2023 has further strained the health system. Reports indicate that many health facilities in conflict-affected areas, including Northern State, have closed or are functioning at reduced capacity, severely limiting access to essential maternal healthcare. Socioeconomic factors such as low income, limited education, rural residence, and lack of health insurance are known to increase the risk of pregnancy complications. Obstetric history, including previous cesarean sections, miscarriages, preterm births, and chronic illnesses, also contributes to adverse maternal outcomes. Infection during pregnancy is particularly concerning as a strong predictor of complications. Currently, there is a knowledge gap regarding the prevalence and determinants of midtrimester pregnancy complications in Northern State, as pre-conflict data no longer reflect the current reality. Understanding these factors is critical to guide interventions, strengthen antenatal care, and improve maternal outcomes in this conflict-affected region. Objectives Primary Objective: • To determine the maternal and socioeconomic determinants of mid-trimester pregnancy complications among women attending health facilities in Northern State, Sudan. Secondary Objectives: 1. To estimate the prevalence of mid-trimester pregnancy complications in Northern State. 2. To assess the association between socioeconomic factors (income, education, residence, health insurance) and pregnancy complications. 3. To evaluate obstetric and medical risk factors, including previous cesarean section, gravidity, parity, chronic illness, and infections, for mid-trimester complications. Methods Study Design and Setting This will be a cross-sectional analytical study conducted in Northern State, Sudan. Data will be collected from both primary and referral health facilities in urban and rural areas of the state. Study Population The study population will include pregnant women in their second trimester presenting to participating health facilities. Inclusion Criteria: 1. Sudanese women 2. Gestational age between 13 and 27 weeks (confirmed by last menstrual period or ultrasound) 3. Complete medical follow-up card 4. Ability to provide informed consent Exclusion Criteria: • Critically unstable women unable to participate after stabilization • Incomplete medical follow-up card Sampling Technique • Facility Selection: Purposive sampling of functional health facilities due to conflict-related closures. • Participant Recruitment: Consecutive sampling of all eligible women presenting to selected facilities until the sample size is reached. Data Collection Instrument A structured interviewer-administered questionnaire, validated through expert review and pilot testing, will be used. Sections include: 1. Socio-demographic characteristics: age, residence, education, income, health insurance, marital status 2. Obstetric and medical history: gravidity, parity, prior cesarean sections, miscarriages, chronic illnesses, infections 3. Clinical presentation and management 4. Outcome variables: presence or absence of pregnancy-related complications Operational Definitions • Pregnancy-related complications: Clinically diagnosed maternal complications such as infection, hemorrhage, miscarriage-related complications, preterm labor, or sepsis. • Infection during pregnancy: Diagnosis confirmed by attending physician or laboratory, or symptoms consistent with urinary tract infection, malaria, dengue, or other infectious conditions. Data Management and Analysis • Data will be collected using Google Forms and analyzed with Jamovi (version 2.3.8).

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, including its purpose, procedures, potential risks and benefits, and their rights as participants. They will be informed that participation is entirely voluntary and that they can withdraw at any time without affecting their access to healthcare services. Informed consent will be obtained verbally or in writing depending on their literacy level.
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
• Evidence-based planning: Provides up-to-date, locally relevant data on maternal complications in Northern State, especially in a conflict-affected context. • Policy guidance: Helps health authorities and NGOs design targeted interventions, resource allocation, and maternal health programs. • Maternal health improvement: Identifies high-risk populations, enabling policymakers to prioritize preventive care and early intervention.
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: Pregnancy-related complications are a major public health challenge worldwide, particularly in low- and lower-middle-income countries. Sub-Saharan Africa carries the highest burden, with maternal mortality ratios exceeding the global average by more than twofold. Sudan has historically faced high maternal mortality, and the armed conflict that began in April 2023 has further strained the health system. Reports indicate that many health facilities in conflict-affected areas, including Northern State, have closed or are functioning at reduced capacity, severely limiting access to essential maternal healthcare. Socioeconomic factors such as low income, limited education, rural residence, and lack of health insurance are known to increase the risk of pregnancy complications. Obstetric history, including previous cesarean sections, miscarriages, preterm births, and chronic illnesses, also contributes to adverse maternal outcomes. Infection during pregnancy is particularly concerning as a strong predictor of complications. Currently, there is a knowledge gap regarding the prevalence and determinants of midtrimester pregnancy complications in Northern State, as pre-conflict data no longer reflect the current reality. Understanding these factors is critical to guide interventions, strengthen antenatal care, and improve maternal outcomes in this conflict-affected region. Objectives Primary Objective: • To determine the maternal and socioeconomic determinants of mid-trimester pregnancy complications among women attending health facilities in Northern State, Sudan. Secondary Objectives: 1. To estimate the prevalence of mid-trimester pregnancy complications in Northern State. 2. To assess the association between socioeconomic factors (income, education, residence, health insurance) and pregnancy complications. 3. To evaluate obstetric and medical risk factors, including previous cesarean section, gravidity, parity, chronic illness, and infections, for mid-trimester complications. Methods Study Design and Setting This will be a cross-sectional analytical study conducted in Northern State, Sudan. Data will be collected from both primary and referral health facilities in urban and rural areas of the state. Study Population The study population will include pregnant women in their second trimester presenting to participating health facilities. Inclusion Criteria: 1. Sudanese women 2. Gestational age between 13 and 27 weeks (confirmed by last menstrual period or ultrasound) 3. Complete medical follow-up card 4. Ability to provide informed consent Exclusion Criteria: • Critically unstable women unable to participate after stabilization • Incomplete medical follow-up card Sampling Technique • Facility Selection: Purposive sampling of functional health facilities due to conflict-related closures. • Participant Recruitment: Consecutive sampling of all eligible women presenting to selected facilities until the sample size is reached. Data Collection Instrument A structured interviewer-administered questionnaire, validated through expert review and pilot testing, will be used. Sections include: 1. Socio-demographic characteristics: age, residence, education, income, health insurance, marital status 2. Obstetric and medical history: gravidity, parity, prior cesarean sections, miscarriages, chronic illnesses, infections 3. Clinical presentation and management 4. Outcome variables: presence or absence of pregnancy-related complications Operational Definitions • Pregnancy-related complications: Clinically diagnosed maternal complications such as infection, hemorrhage, miscarriage-related complications, preterm labor, or sepsis. • Infection during pregnancy: Diagnosis confirmed by attending physician or laboratory, or symptoms consistent with urinary tract infection, malaria, dengue, or other infectious conditions. Data Management and Analysis • Data will be collected using Google Forms and analyzed with Jamovi (version 2.3.8).

Mar 09, 2026 - May 06, 2026

Mar 11, 2026 - Apr 03, 2026

الاعتبارات الأخلاقية / Ethical Considerations

Written

مخاطر منخفضة - Low Risk

All participants will be provided with clear information about the study, including its purpose, procedures, potential risks and benefits, and their rights as participants. They will be informed that participation is entirely voluntary and that they can withdraw at any time without affecting their access to healthcare services. Informed consent will be obtained verbally or in writing depending on their literacy level.

• Evidence-based planning: Provides up-to-date, locally relevant data on maternal complications in Northern State, especially in a conflict-affected context. • Policy guidance: Helps health authorities and NGOs design targeted interventions, resource allocation, and maternal health programs. • Maternal health improvement: Identifies high-risk populations, enabling policymakers to prioritize preventive care and early intervention.