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NCT Number: NCT07810751

Health Education to Reduce Unnecessary Cesarean Section Among Primigravida Women

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 of the health educational program among the study and control groups. 2. To develop and implement a health educational program regarding cesarean section and normal vaginal delivery. 3. 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. 4. To evaluate the actual mode of delivery among primigravida women after implementation of the health educational program in both the study and control groups.

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Key information

Conditions

Cesarean Section Adherence Interventions Behavior Health Behavior Health Education Medication Adherence Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Women's Health Hospital, Assiut University

Asyut, Asyut Governorate, 71511, Egypt

Location status: Recruiting

Location contact

Aya S Abd Elhakim, assistant lecturer

CONTACT

[email protected]

+01140290229

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women in their third trimester.
  • Women with singleton pregnancy.
  • Women willing to participate in the study.
  • No indications for cesarean delivery.

Exclusion criteria

-

Treatment and study plan

Health Educational Program on Modes of Delivery.

Behavioral
  • 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.

Primary outcomes

  1. 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)

    • 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.

Secondary outcomes

  1. Mean Change in Attitude Score Measured by the Attitudes Toward Modes of Delivery Questionnaire.

    Time frame: Baseline and 4 weeks after the educational intervention

    • 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.

  2. 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.

    • 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.

  3. Mean Change in Knowledge Score Measured by the Knowledge Regarding Modes of Delivery Questionnaire.

    Time frame: Baseline and 4 weeks after the educational intervention

    • 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aya S Abd Elhakim, assistant lecturer

CONTACT

[email protected]

+01140290229

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Effectiveness of Health Educational Program for Primigravida Women in Reducing the Rate of Unnecessary Cesarean Section

Acronym: CS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 9, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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