Antenatal EducationNCT06561984
Effect of Antenatal Education on Knowledge,Attitude and Preferences Taward Delivery Modes
A study testing antenatal education in people with Antenatal Education and Modes of Delivery, run by Mansoura University at 1 site in Egypt.
Trial summary
The aim of the current study is to assess the effect of antenatal education on pregnant women's knowledge, attitude, and preferences of delivery mode. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Antenatal Education, Modes of Delivery
- What is being tested?
- antenatal education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2024to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women who are 18 to 35 years old.
- A singleton pregnancy in the third
- Primigravida and pregnant women with a history of one prior elective cesarean section at least two years between pregnancies.
Who cannot join
- Pregnant women who has any indication of a cesarean section or obstetrical issues that have arisen during the present pregnancy
- Pregnant woman who suffer from psychological illness.
Trial locations and contacts
1 site in 1 country.
Hanan Elsayed, professor contact
About this study
Official title: Effect of Antenatal Education on Pregnant Women's Knowledge, Attitude and Preferences of Delivery Mode
The aim of the current study is to assess the effect of antenatal education on pregnant women's knowledge, attitude, and preferences of delivery mode.
Read the detailed description
This study employed a quasi-experimental design with intervention and control group. The purposive sample will consisted of 140 pregnant women who attended for prenatal care for follow up at the previously mentioned setting. The main objective of the study will to examine the effect of antenatal education on pregnant women's knowledge, attitude, and preferences toward the mode of delivery.
In order to accomplish the study's aim, the following research hypothesis is developed:
Hypothesis 1. Pregnant women who receive antenatal education will have a higher level of knowledge and positive attitude regarding the mode of delivery than those in the control group.
- Conditions
- Antenatal Education, Modes of Delivery
- Being tested
- antenatal education
- Keywords
- Antenatal Education, Knowledge, attitude, Mode of delivery
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antenatal educationBehavioural
Giving educational sessions to the intervention group regarding modes of delivery
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group will receive antenatal educational sessions regarding modes of delivery in addition to the routine care in the antenatal clinic Receives: Behavioral: antenatal education |
| Control group | No intervention | The control group will receive only the routine care in the antenatal clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structured Interviewing Questionnaire.
This tool was designed by the researcher after an extensive review of the related national and international literature and was filled by the researcher It consists of three parts:
Part I: Studied pregnant women's general characteristics including age, educational level of the mother and husband, residence, etc…).
Part II: Obstetrical history of the studied pregnant women including gravidity, parity, history of abortion, type of previous C.S, inter-pregnancy interval, etc…).
Part III: Knowledge of the studied pregnant women toward mode of delivery.
Measured: 6 months
Tool II: Attitude of the studied pregnant women toward mode of delivery questionnaire
It was developed by the researcher. Its primary objective was to assess pregnant women attitude toward delivery mode, it consists of two parts:
Part I: Attitude of the studied pregnant women toward vaginal delivery:
Part II: Attitude of the studied pregnant women toward Cesarean section:
Measured: 6 months
Tool III: Studied pregnant women's preference of delivery mode sheet.
The researcher developed this tool after reviewing the relevant literature (Elgzar, Alshahrani, \& Ibrahim, 2023) to assess pregnant women preference of delivery mode. It included two items (the type of delivery mode as normal vaginal delivery or cesarean section and causes for choosing this mode of delivery, including labor pain, the cost, doctor preference, health beliefs regarding mode of delivery, the most common mode of delivery, having previous knowledge toward the mode of delivery, and having knowledge from an educational program, etc…).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study startSep 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Antenatal EducationStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The intervention group will receive educational sessions regarding modes of delivery, while the control group will receive the routine antenatal care only in the antenatal clinics
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Hassan Ragab Elshrqawy, Mansoura University
- Investigators
- Eman Elshrqawy, Assist. lec, Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561984
- Sponsor's protocol ID
- Antenatal Education
- Status last verified
- Aug 2024
- First submitted
- 11 Aug 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Akinlusi FM, Olayiwola AA, Rabiu KA, Oshodi YA, Ottun TA, Shittu KA. Prior childbirth experience and attitude towards subsequent vaginal birth after one caesarean delivery in Lagos, Nigeria: a cross-sectional study. BMC Pregnancy Childbirth. 2023 Jan 30;23(1):82. doi: 10.1186/s12884-023-05348-4.
PubMed 36717780AlSomali Z, Bajamal E, Esheaba O. The Effect of Structured Antenatal Education on Childbirth Self-Efficacy. Cureus. 2023 May 21;15(5):e39285. doi: 10.7759/cureus.39285. eCollection 2023 May.
PubMed 37223341Grobman WA, Sandoval GJ, Rice MM, Chauhan SP, Clifton RG, Costantine MM, Gibson KS, Metz TD, Parry S, Reddy UM, Rouse DJ, Saade GR, Simhan HN, Thorp JM Jr, Tita ATN, Yee L, Longo M, Landon MB; of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Prediction of vaginal birth after cesarean using information at admission for delivery: a calculator without race or ethnicity. Am J Obstet Gynecol. 2024 Mar;230(3S):S804-S806. doi: 10.1016/j.ajog.2023.02.008. Epub 2023 Jul 14. No abstract available.
PubMed 38180754Gebremichael MA, Lema TB. Prevalence and Predictors of Knowledge and Attitude on Optimal Nutrition and Health Among Pregnant Women in Their First Trimester of Pregnancy. Int J Womens Health. 2023 Sep 4;15:1383-1395. doi: 10.2147/IJWH.S415615. eCollection 2023.
PubMed 37692922Al-Rifai RH, Elbarazi I, Ali N, Loney T, Oulhaj A, Ahmed LA. Knowledge and Preference Towards Mode of Delivery among Pregnant Women in the United Arab Emirates: The Mutaba'ah Study. Int J Environ Res Public Health. 2020 Dec 23;18(1):36. doi: 10.3390/ijerph18010036.
PubMed 33374611Zewude B, Siraw G, Adem Y. The Preferences of Modes of Child Delivery and Associated Factors Among Pregnant Women in Southern Ethiopia. Pragmat Obs Res. 2022 Jul 15;13:59-73. doi: 10.2147/POR.S370513. eCollection 2022.
PubMed 35873720Elgzar WT, Alshahrani MS, Ibrahim HA. Mode of delivery preferences: the role of childbirth fear among nulliparous women. Front Psychol. 2023 Nov 16;14:1221133. doi: 10.3389/fpsyg.2023.1221133. eCollection 2023.
PubMed 38034315El-Shrqawy EH, Elnemer A, Mohamed Elsayed H. Effect of antenatal education on pregnant women;s knowledge, attitude and preferences of delivery mode. BMC Pregnancy Childbirth. 2024 Nov 12;24(1):740. doi: 10.1186/s12884-024-06922-0.
PubMed 39533248
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Antenatal Education on Pregnant Women's Knowledge, Attitude and Preferences of Delivery Mode
- ClinicalTrials.gov ID
- NCT06561984
- Acronym / sponsor ID
- Antenatal Education
- Conditions
- Antenatal Education, Modes of Delivery
- Keywords
- Antenatal Education, Knowledge, attitude, Mode of delivery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 20 Aug 2024 (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.
The aim of the current study is to assess the effect of antenatal education on pregnant women's knowledge, attitude, and preferences of delivery mode.
Detailed description
This study employed a quasi-experimental design with intervention and control group. The purposive sample will consisted of 140 pregnant women who attended for prenatal care for follow up at the previously mentioned setting. The main objective of the study will to examine the effect of antenatal education on pregnant women's knowledge, attitude, and preferences toward the mode of delivery.
In order to accomplish the study's aim, the following research hypothesis is developed:
Hypothesis 1. Pregnant women who receive antenatal education will have a higher level of knowledge and positive attitude regarding the mode of delivery than those in the control group.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The intervention group will receive educational sessions regarding modes of delivery, while the control group will receive the routine antenatal care only in the antenatal clinics
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: antenatal educationThe intervention group will receive antenatal educational sessions regarding modes of delivery in addition to the routine care in the antenatal clinic |
| Control group | No intervention | –The control group will receive only the routine care in the antenatal clinic |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant women who are 18 to 35 years old.
- A singleton pregnancy in the third
- Primigravida and pregnant women with a history of one prior elective cesarean section at least two years between pregnancies.
Key exclusion criteria (2 listed)
- Pregnant women who has any indication of a cesarean section or obstetrical issues that have arisen during the present pregnancy
- Pregnant woman who suffer from psychological illness.
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 |
|---|---|---|
| antenatal educationGiving educational sessions to the intervention group regarding modes of delivery | Behavioural | Intervention group |
Primary outcome
Structured Interviewing Questionnaire.
Time frame: 6 months
This tool was designed by the researcher after an extensive review of the related national and international literature and was filled by the researcher It consists of three parts: Part I: Studied pregnant women's general characteristics including age, educational level of the mother and husband, residence, etc…). Part II: Obstetrical history of the studied pregnant women including gravidity, parity, history of abortion, type of previous C.S, inter-pregnancy interval, etc…). Part III: Knowledge of the studied pregnant women toward mode of delivery.
Tool II: Attitude of the studied pregnant women toward mode of delivery questionnaire
Time frame: 6 months
It was developed by the researcher. Its primary objective was to assess pregnant women attitude toward delivery mode, it consists of two parts: Part I: Attitude of the studied pregnant women toward vaginal delivery: Part II: Attitude of the studied pregnant women toward Cesarean section:
Tool III: Studied pregnant women's preference of delivery mode sheet.
Time frame: 6 months
The researcher developed this tool after reviewing the relevant literature (Elgzar, Alshahrani, \& Ibrahim, 2023) to assess pregnant women preference of delivery mode. It included two items (the type of delivery mode as normal vaginal delivery or cesarean section and causes for choosing this mode of delivery, including labor pain, the cost, doctor preference, health beliefs regarding mode of delivery, the most common mode of delivery, having previous knowledge toward the mode of delivery, and having knowledge from an educational program, etc…).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Background: PubMed 36717780Akinlusi FM, Olayiwola AA, Rabiu KA, Oshodi YA, Ottun TA, Shittu KA. Prior childbirth experience and attitude towards subsequent vaginal birth after one caesarean delivery in Lagos, Nigeria: a cross-sectional study. BMC Pregnancy Childbirth. 2023 Jan 30;23(1):82. doi: 10.1186/s12884-023-05348-4.
- Background: PubMed 37223341AlSomali Z, Bajamal E, Esheaba O. The Effect of Structured Antenatal Education on Childbirth Self-Efficacy. Cureus. 2023 May 21;15(5):e39285. doi: 10.7759/cureus.39285. eCollection 2023 May.
- Background: PubMed 38180754Grobman WA, Sandoval GJ, Rice MM, Chauhan SP, Clifton RG, Costantine MM, Gibson KS, Metz TD, Parry S, Reddy UM, Rouse DJ, Saade GR, Simhan HN, Thorp JM Jr, Tita ATN, Yee L, Longo M, Landon MB; of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Prediction of vaginal birth after cesarean using information at admission for delivery: a calculator without race or ethnicity. Am J Obstet Gynecol. 2024 Mar;230(3S):S804-S806. doi: 10.1016/j.ajog.2023.02.008. Epub 2023 Jul 14. No abstract available.
- Background: PubMed 37692922Gebremichael MA, Lema TB. Prevalence and Predictors of Knowledge and Attitude on Optimal Nutrition and Health Among Pregnant Women in Their First Trimester of Pregnancy. Int J Womens Health. 2023 Sep 4;15:1383-1395. doi: 10.2147/IJWH.S415615. eCollection 2023.
- Background: PubMed 33374611Al-Rifai RH, Elbarazi I, Ali N, Loney T, Oulhaj A, Ahmed LA. Knowledge and Preference Towards Mode of Delivery among Pregnant Women in the United Arab Emirates: The Mutaba'ah Study. Int J Environ Res Public Health. 2020 Dec 23;18(1):36. doi: 10.3390/ijerph18010036.
- Background: PubMed 35873720Zewude B, Siraw G, Adem Y. The Preferences of Modes of Child Delivery and Associated Factors Among Pregnant Women in Southern Ethiopia. Pragmat Obs Res. 2022 Jul 15;13:59-73. doi: 10.2147/POR.S370513. eCollection 2022.
- Background: PubMed 38034315Elgzar WT, Alshahrani MS, Ibrahim HA. Mode of delivery preferences: the role of childbirth fear among nulliparous women. Front Psychol. 2023 Nov 16;14:1221133. doi: 10.3389/fpsyg.2023.1221133. eCollection 2023.
- Derived from this study: PubMed 39533248El-Shrqawy EH, Elnemer A, Mohamed Elsayed H. Effect of antenatal education on pregnant women;s knowledge, attitude and preferences of delivery mode. BMC Pregnancy Childbirth. 2024 Nov 12;24(1):740. doi: 10.1186/s12884-024-06922-0.
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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. This study is not recruiting at the moment.
Hanan Elsayed, professor contact
Eman Elshrqawy, Assist. lec study chair
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing antenatal education in people with Antenatal Education and Modes of Delivery, run by Mansoura 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 20 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eman Elshrqawy, assist/ lec (01554546002, eman_hassan@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structured Interviewing Questionnaire. (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06561984, which also lists 8 linked publications.
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 20 Aug 2024.