Cesarean SectionCSNCT07810751
Health Education to Reduce Unnecessary Cesarean Section Among Primigravida Women
A study testing Health Educational Program on Modes of Delivery. in people with Cesarean Section, run by Assiut University at 1 site in Egypt.
Trial summary
This study aims to evaluate the Effectiveness of Health Educational Program for Primigravida Women in Reducing the Rate of Unnecessary Cesarean Section. Specific objectives: 1. To assess primigravida women's knowledge and attitudes regarding cesarean section and normal vaginal delivery before and after implementation… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Health Educational Program on Modes of Delivery.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2026to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnant women in their third trimester.
- Women with singleton pregnancy.
- Women willing to participate in the study.
- No indications for cesarean delivery.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Women's Health Hospital, Assiut University
Asyut, Asyut Governorate, 71511
Aya S Abd Elhakim, assistant lecturer, +01140290229, ayasalah@aun.edu.eg
About this study
Official title: Effectiveness of Health Educational Program for Primigravida Women in Reducing the Rate of Unnecessary Cesarean Section
This study aims to evaluate the Effectiveness of Health Educational Program for Primigravida Women in Reducing the Rate of Unnecessary Cesarean Section.
Specific objectives:
- To assess primigravida women's knowledge and attitudes regarding cesarean section and normal vaginal delivery before and after implementation of the health educational program among the study and control groups.
- To develop and implement a health educational program regarding cesarean section and normal vaginal delivery.
- To assess primigravida women's choice regarding the mode of delivery before and after implementation of the health educational program among the study and control groups.
- To evaluate the actual mode of delivery among primigravida women after implementation of the health educational program in both the study and control groups.
Read the detailed description
- Cesarean section is an essential and potentially life-saving intervention when medically indicated. However, cesarean delivery without a clear medical indication may expose women and newborns to avoidable short- and long-term risks. Inadequate knowledge, fear of labor, misconceptions regarding vaginal delivery, and external influences may affect pregnant women's preferences regarding the mode of delivery.
- This study will use a quasi-experimental, two-group, pretest-posttest design. A purposive sample of 120 eligible primigravida women in the third trimester of pregnancy will be recruited from the antenatal clinic at Women's Health Hospital, Assiut University. Participants will be assigned to an intervention group of 60 women and a control group of 60 women.
- At baseline, women in both groups will complete assessments of sociodemographic and pregnancy-related characteristics, knowledge regarding vaginal and cesarean delivery, attitudes toward modes of delivery, and preferred mode of delivery.
- The intervention group will receive a structured health educational program covering the definition, indications, advantages, risks, and complications of vaginal and cesarean delivery. The program will be supported by illustrated materials and an Arabic educational booklet. The control group will receive routine antenatal care.
- the post-test will be completed after the intervention, knowledge, attitudes, and mode-of-delivery choice will be reassessed in both groups using the same assessment instruments. After childbirth, participants will be contacted to determine their actual mode of delivery. For participants who undergo cesarean delivery, the documented reason for the procedure will be recorded.
- Conditions
- Cesarean Section
- Being tested
- Health Educational Program on Modes of Delivery.
- Keywords
- Unnecessary Cesarean section, Vaginal delivery, Primigravida women, Health education, knowledge, attitudes
- Medical subject headings
- Health Education, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Educational Program on Modes of Delivery.Behavioural
- A structured antenatal health educational program on Modes of Delivery delivered by the investigator to primigravida women. The program provides evidence-based information regarding normal vaginal delivery and cesarean section, including definitions, medical indications, advantages, risks, maternal and neonatal complications, and common misconceptions regarding both modes of delivery.
- The educational program is supported by illustrated educational materials and an Arabic booklet prepared by the researcher.
| Study group | Role | What they receive |
|---|---|---|
| Health Educational Program | Experimental | A structured antenatal health educational program on Modes of Delivery delivered by the investigator to primigravida women. The program provides evidence-based information concerning vaginal delivery and cesarean section, including indications, advantages, risks, complications, and common misconceptions. Education will be supported by illustrated materials and an Arabic booklet. Participants may communicate with the investigator by telephone or WhatsApp for study-related follow-up. Receives: Behavioral: Health Educational Program on Modes of Delivery. |
| Routine Antenatal Care | No intervention | Participants will receive the routine antenatal care provided at the antenatal clinic without receiving the structured health educational program during the study assessment period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Undergoing Cesarean Delivery, Assessed Using the Actual Mode of Delivery Data Collection Form
- The actual mode of delivery will be assessed using the researcher-developed Actual Mode of Delivery Data Collection Form during postpartum follow-up. The participant's mode of delivery will be classified as vaginal delivery or cesarean delivery.
- The number of participants who undergo cesarean delivery will be divided by the total number of participants in each study arm who complete delivery follow-up and multiplied by 100. The outcome will be reported as the percentage of participants who undergo cesarean delivery in each study arm. The unit of measure is percentage of participants
- For participants who undergo cesarean delivery, the reason for the cesarean procedure will also be recorded.
Measured: during postpartum period (within 6 weeks postpartum)
Secondary outcomes (3)
Mean Change in Attitude Score Measured by the Attitudes Toward Modes of Delivery Questionnaire.
- Participants' attitudes toward normal vaginal delivery and cesarean delivery will be assessed using the researcher-administered Attitudes Toward Modes of Delivery Questionnaire. The questionnaire consists of 15 statements rated on a 3-point Likert scale.
- For positively worded statements, "agree" is scored 2 points, "uncertain" is scored 1 point, and "disagree" is scored 0 points. Negatively worded statements will be reverse scored, as appropriate. Item scores are summed to produce a total attitude score ranging from 0 to 30 points, with higher scores indicating a more positive attitude toward evidence-based selection of the mode of delivery.
- A total score of 18 to 30 points is categorized as a positive attitude, while a score of 0 to 17 points is categorized as a negative attitude. The outcome will be reported as the mean change in the total attitude score from baseline to 4 weeks after the educational intervention. The unit of measure is points.
Measured: Baseline and 4 weeks after the educational intervention
Percentage of Participants Preferring Vaginal Delivery Measured by the Women's Choice of Mode of Delivery Questionnaire.
- Participants' preferred mode of delivery will be assessed using the Women's Choice of Mode of Delivery Questionnaire. The questionnaire asks each participant to select her preferred mode of delivery as either normal vaginal delivery or cesarean delivery.
- The questionnaire also assesses the reported reasons for the participant's preference, including labor pain, cost, physician preference, health beliefs, familiarity with the mode of delivery, previous knowledge, and information received through the educational program.
- The outcome will be reported as the percentage of participants who select normal vaginal delivery as their preferred mode of delivery at baseline and at 4 weeks after the educational intervention. The unit of measure is percentage of participants.
Measured: Baseline and 4 weeks after the educational intervention.
Mean Change in Knowledge Score Measured by the Knowledge Regarding Modes of Delivery Questionnaire.
- Participants' knowledge regarding normal vaginal delivery and cesarean delivery will be assessed using the researcher-administered Knowledge Regarding Modes of Delivery Questionnaire. The questionnaire consists of 30 items covering the definition of cesarean delivery, maternal and fetal indications for cesarean delivery, and maternal, fetal, and neonatal complications associated with the modes of delivery.
- Each correct answer is scored 2 points, an "I do not know" answer is scored 1 point, and an incorrect answer is scored 0 points. Item scores are summed to produce a total knowledge score ranging from 0 to 60 points, with higher scores indicating greater knowledge. Knowledge levels are categorized as poor knowledge (less than 30 points), fair knowledge (30 to 44 points), or good knowledge (45 to 60 points).
- The outcome will be reported as the mean change in the total knowledge score from baseline to 4 weeks after the educational intervention. The unit of measure is points.
Measured: Baseline and 4 weeks after the educational intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start1 Jul 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Eligible participants will be assigned to one of two parallel groups. The study (Intervention) group will receive the structured health educational program on Modes of Delivery in addition to routine antenatal care, while the control group will receive routine antenatal care only.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Salah Abd Elhakim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810751
- Sponsor's protocol ID
- 1120261457
- Acronym
- CS
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Health Educational Program for Primigravida Women in Reducing the Rate of Unnecessary Cesarean Section
- ClinicalTrials.gov ID
- NCT07810751
- Acronym / sponsor ID
- CS / 1120261457
- Conditions
- Cesarean Section
- Keywords
- Unnecessary Cesarean section, Vaginal delivery, Primigravida women, Health education, knowledge, attitudes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the Effectiveness of Health Educational Program for Primigravida Women in Reducing the Rate of Unnecessary Cesarean Section.
Specific objectives:
- To assess primigravida women's knowledge and attitudes regarding cesarean section and normal vaginal delivery before and after implementation of the health educational program among the study and control groups.
- To develop and implement a health educational program regarding cesarean section and normal vaginal delivery.
- To assess primigravida women's choice regarding the mode of delivery before and after implementation of the health educational program among the study and control groups.
- To evaluate the actual mode of delivery among primigravida women after implementation of the health educational program in both the study and control groups.
Detailed description
- Cesarean section is an essential and potentially life-saving intervention when medically indicated. However, cesarean delivery without a clear medical indication may expose women and newborns to avoidable short- and long-term risks. Inadequate knowledge, fear of labor, misconceptions regarding vaginal delivery, and external influences may affect pregnant women's preferences regarding the mode of delivery.
- This study will use a quasi-experimental, two-group, pretest-posttest design. A purposive sample of 120 eligible primigravida women in the third trimester of pregnancy will be recruited from the antenatal clinic at Women's Health Hospital, Assiut University. Participants will be assigned to an intervention group of 60 women and a control group of 60 women.
- At baseline, women in both groups will complete assessments of sociodemographic and pregnancy-related characteristics, knowledge regarding vaginal and cesarean delivery, attitudes toward modes of delivery, and preferred mode of delivery.
- The intervention group will receive a structured health educational program covering the definition, indications, advantages, risks, and complications of vaginal and cesarean delivery. The program will be supported by illustrated materials and an Arabic educational booklet. The control group will receive routine antenatal care.
- the post-test will be completed after the intervention, knowledge, attitudes, and mode-of-delivery choice will be reassessed in both groups using the same assessment instruments. After childbirth, participants will be contacted to determine their actual mode of delivery. For participants who undergo cesarean delivery, the documented reason for the procedure will be recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible participants will be assigned to one of two parallel groups. The study (Intervention) group will receive the structured health educational program on Modes of Delivery in addition to routine antenatal care, while the control group will receive routine antenatal care only.
| Arm | Type | Receives |
|---|---|---|
| Health Educational Program | Experimental | Behavioral: Health Educational Program on Modes of Delivery.A structured antenatal health educational program on Modes of Delivery delivered by the investigator to primigravida women. The program provides evidence-based information concerning vaginal delivery and cesarean section, including indications, advantages, risks, complications, and common misconceptions. Education will be supported by illustrated materials and an Arabic booklet. Participants may communicate with the investigator by telephone or WhatsApp for study-related follow-up. |
| Routine Antenatal Care | No intervention | –Participants will receive the routine antenatal care provided at the antenatal clinic without receiving the structured health educational program during the study assessment period. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Pregnant women in their third trimester.
- Women with singleton pregnancy.
- Women willing to participate in the study.
- No indications for cesarean delivery.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Educational Program on Modes of Delivery.1. A structured antenatal health educational program on Modes of Delivery delivered by the investigator to primigravida women. The program provides evidence-based information regarding normal vaginal delivery and cesarean section, including definitions, medical indications, advantages, risks, maternal and neonatal complications, and common misconceptions regarding both modes of delivery. 2. The educational program is supported by illustrated educational materials and an Arabic booklet prepared by the researcher. | Behavioural | Health Educational Program |
Primary outcome
Percentage of Participants Undergoing Cesarean Delivery, Assessed Using the Actual Mode of Delivery Data Collection Form
Time frame: during postpartum period (within 6 weeks postpartum)
1. The actual mode of delivery will be assessed using the researcher-developed Actual Mode of Delivery Data Collection Form during postpartum follow-up. The participant's mode of delivery will be classified as vaginal delivery or cesarean delivery. 2. The number of participants who undergo cesarean delivery will be divided by the total number of participants in each study arm who complete delivery follow-up and multiplied by 100. The outcome will be reported as the percentage of participants who undergo cesarean delivery in each study arm. The unit of measure is percentage of participants 3. For participants who undergo cesarean delivery, the reason for the cesarean procedure will also be recorded.
3 secondary outcomes
Mean Change in Attitude Score Measured by the Attitudes Toward Modes of Delivery Questionnaire.
Time frame: Baseline and 4 weeks after the educational intervention
Percentage of Participants Preferring Vaginal Delivery Measured by the Women's Choice of Mode of Delivery Questionnaire.
Time frame: Baseline and 4 weeks after the educational intervention.
Mean Change in Knowledge Score Measured by the Knowledge Regarding Modes of Delivery Questionnaire.
Time frame: Baseline and 4 weeks after the educational intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Active, not recruiting
Implementation of a Disparities in Labor Outcomes Dashboard
Labor Induction, Cesarean Birth
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Educational Program on Modes of Delivery. in people with Cesarean Section, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aya S Abd Elhakim, assistant lecturer (+01140290229, ayasalah@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Undergoing Cesarean Delivery, Assessed Using the Actual Mode of Delivery Data Collection Form (time frame: during postpartum period (within 6 weeks postpartum)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.