NCT07810751

Brief 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. 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. 2.To develop and implement a health educational program regarding cesarean section and normal vaginal delivery.
  3. 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress57%
Jul 2026Dec 2026

Study Start

First participant enrolled

July 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 9, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Last Updated

September 9, 2026

Status Verified

August 1, 2026

Enrollment Period

5 months

First QC Date

August 27, 2026

Last Update Submit

September 3, 2026

Conditions

Keywords

Unnecessary Cesarean sectionVaginal deliveryPrimigravida womenHealth educationknowledgeattitudes

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Undergoing Cesarean Delivery, Assessed Using the Actual Mode of Delivery Data Collection Form

    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.

    during postpartum period (within 6 weeks postpartum)

Secondary Outcomes (3)

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

    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.

    Baseline and 4 weeks after the educational intervention.

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

    Baseline and 4 weeks after the educational intervention

Study Arms (2)

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.

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.

Interventions

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.

Health Educational Program

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's Health Hospital, Assiut University

Asyut, Asyut Governorate, 71511, Egypt

RECRUITING

MeSH Terms

Conditions

Health EducationBehavior

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Central Study Contacts

Aya S Abd Elhakim, assistant lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator.

Study Record Dates

First Submitted

August 27, 2026

First Posted

September 9, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 15, 2026

Last Updated

September 9, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations