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Preconception Care, Preconception RiskNCT06272188

Preconception Care for Couples Planning Pregnancy

A study testing web-based online preconceptional counselling in people with Preconception Care, Preconception Risk, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Preconception care is to optimize health, address modifiable risk factors, and eliminate or reduce health-threatening factors for the woman, fetus, and newborn by working with couples to achieve a healthy pregnancy. Preconception care is the best way to protect against risks in pregnancy and plan risk management. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Preconception Care, Preconception Risk
What is being tested?
web-based online preconceptional counselling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Feb 2024to 15 Aug 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
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Repuclic of Turkiye to be a citizen
  • Being at least a primary school graduate
  • Being over 18 years of age
  • Having applied to the marriage office to get a wedding date.
  • No communication barrier (such as deafness)
  • Being married for the first time (both men and women having their first marriage)
  • Not having experienced pregnancy
  • The couple wants to have children in the future

Who cannot join

  • Being under 18 years of age
  • Miscarriage, abortion, stillbirth, birth, etc. Having had a pregnancy that resulted in
  • Having received training on preconception care.
  • Presence of a diagnosed psychiatric disease (schizophrenia, manic depressive disorder, etc.)
  • Not having the necessary technological infrastructure for online consultancy.
  • The woman is in menopause
  • Being pregnant
  • Being a healthcare worker (Doctor, Nurse, Midwife)

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Van Yuzuncu Yil University

    Van

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Online Preconception Counseling on Information and Care Practices for Couples Planning Pregnancy for Healthy Beginnings

Preconception care is to optimize health, address modifiable risk factors, and eliminate or reduce health-threatening factors for the woman, fetus, and newborn by working with couples to achieve a healthy pregnancy. Preconception care is the best way to protect against risks in pregnancy and plan risk management. Preconception care offers women and their partners the opportunity to gain healthy lifestyle behaviors, make conscious choices, and gain awareness of factors that threaten health before, during and after pregnancy. However, the rate of receiving preconception care is only 12.3% in our country.

The aim of this project is to examine the effect of online preconception counseling on information and care practices for couples planning pregnancy for healthy starts.

Read more

Materials and Methods:

The randomized controlled experimental study will be conducted between February 1, 2024 and February 1, 2026 in the provinces of Istanbul, Izmir, Kastamonu, Ankara and Van. The population of the research will consist of all couples who applied to the marriage offices in the above provinces between February 1, 2024 and February 1, 2026. In the sample calculation, it was calculated that at least 80 couples (experimental group: 40 couples, control group: 40 couples) should be included in the study. Couples that meet the sampling criteria will be assigned to the experimental or control group according to the random numbers table. Online preconception care counseling will be provided to couples in the experimental group 1 month after their wedding date. Preconception care counseling, consisting of 17 titles, was prepared in line with the relevant literature and standardized by the researchers. After the counseling, the couples will be introduced to the preconception care website, which they can use if they need it, and will be given login information.

Data will be obtained before and in the 3rd month after counseling with the Introductory Information Form (TBF), Preconceptional Period Risk Assessment Form, Preconceptional Care Health Literacy Scale and Preconceptional Period Health Behavior Scale. The data will be transferred to the SPSS 22 program and evaluated by the researchers. Chi-square test, t-test, Mann Whitney-U Test, Wilcoxon test and paired simple t test will be used to analyze the data.

Read the detailed description

The subject of the study is preconceptional care counseling. Preconception care is a health care offered for the early detection and prevention of factors that may cause morbidity and mortality in the mother and baby during pregnancy, birth, and postnatal period. A healthy pregnancy and birth need to determine the risks by interviewing couples in the planning stage of pregnancy, to plan/implement interventions to reduce risks and to provide healthy life behaviors to couples. Preconceptional care counseling is a subject that has become increasingly important in recent years. The project is based on this issue.

Organizations such as WHO, CDC, and ACOG have reported that all couples in the preconception period should be evaluated by health professionals, and women who smoke/drink alcohol, have chronic diseases (diabetes, hypertension, hypothyroidism, epilepsy, etc.), are infected with Rubella and Hepatitis-B, have genetic diseases, have folic acid and nutritional deficiencies, are overweight and obese should be considered in the risk group in terms of maternal and fetal morbidity and mortality. It has been reported that it is essential for the protection of maternal and fetal health that all women, especially women in the risk group, receive PCC. For example, the incidence of neural tube defects such as sipina bifida and anencephaly decreases in the babies of women who start taking folic acid at least 1 month before pregnancy. Similarly, maintaining the woman's blood glucose level at normal levels during the PC period has been reported to reduce maternal morbidity, spontaneous abortion, fetal malformations, fetal macrosomia, and neonatal morbidity. Other PCC practices that protect maternal and fetal health include healthy nutrition, physical exercise, weight control, alcohol, and smoking cessation, diagnosis and treatment of chronic diseases, detection of genetic diseases, prevention of exposure to occupational and environmental agents, prevention of over-the-counter drug use, immunization, screening and prevention of infectious diseases, breast examination, dental examination, and cervical evaluation.

In recent years, there have been significant developments in the provision of preconceptional care. One of these is online preconception counseling, which is proposed to be used in this project.

Today, with the advancement of technology and the increasing importance given to education, it has become inevitable to utilize technological opportunities in solving educational problems. Written, audio, and video communication and interaction can be provided over the Internet. The education provided by using internet facilities is called "online education". Functionally, distance education provides the opportunity to learn at any time, place, amount, and speed for those who are working, busy, and want to learn what they need immediately and as much as necessary. Although there are countries in the world that have been providing online education for many years, this technology has only recently started to be used in Turkey. Internet-based education is independent of time and space, can respond to fast or slow learning needs, provides fast access to expert information and the opportunity to work with experts, provides learning opportunities that appeal to multiple senses with multimedia opportunities and reduces the cost of education. The disadvantages of online education are that the internet and computers are required, transportation is difficult in rural areas, and it may prevent socialization.

Online education is most often used in health education. Online preconception counselling is important in raising awareness of couples and helping them to develop positive health behaviors. It makes a difference in couples' understanding of their current situation. For example, in Yenal's study, the effect of web-based counseling on the activities of daily living of pregnant women was examined and 7-week training was given to pregnant women over the internet. In the study, the daily living activities scores of pregnant women gradually increased. In the study, it was found that the pregnant women continued to use the information after the end of the training.

Within the scope of the project;

  1. The relevant literature was examined and it was decided to prepare and implement an online preconception care counseling program consisting of 17 topics in line with the relevant literature.
  2. A website will be prepared in which information material, video, pictures, and question and answer forms will be added in parallel with the information given in online counseling.
  3. To objectively evaluate the effectiveness of the online training, the "Preconceptional Period Risk Assessment Form" planned to be used in the project was prepared by the researchers, and the Turkish validity and reliability of the "Preconceptional Care Health Literacy Scale" was carried out.
  4. The researchers interviewed the marriage offices where the study was planned to be carried out and obtained verbal consent. The permission letters of the institutions have been written and the response is awaited.
Being tested
web-based online preconceptional counselling
Keywords
Preconceptional care, Preconceptional risk factors, Online counseling, Nursing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • web-based online preconceptional counsellingOther

    web-based online preconceptional counselling

Study groups in NCT06272188
Study groupRoleWhat they receive
Experimantal groupExperimentalCouples applying to municipal marriage offices will be invited to participate in a study after obtaining permission. Those agreeing will be briefed by researchers about the study's purpose and methods, signing the IVCF afterward. Using a random number table, couples will be grouped as experimental or control. A month post-wedding, couples receive a call to confirm an online interview appointment. On the set date, a Zoom link for the interview will be shared. During this session, couples complete forms like IIF, PRRA, PCHLS, and PPHBS, followed by online preconception counseling lasting approximately an hour. This counseling, based on relevant literature and standardized by the research team, addresses risks identified during the Preconceptional Period Risk Assessment Form. After three months, couples revisit the PCHLS and PPHBS assessments.
Receives: Other: web-based online preconceptional counselling
Control groupNo interventionNo application will be made to the control group. Note: To act ethically, online preconception care counselling will be given to the participants in the control group after the data are obtained from the experimental and control groups. In addition, the website sagliklibaslangiclar.com will be introduced and it will be explained that they will be able to log in to the website with the username and password they will be given.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Identifying Information Form

    Participants will receive web-based online preconceptional counseling.

    Measured: baseline (pre intervention)

Secondary outcomes (1)
  1. Preconceptional Period Risk Assessment Form

    The preconceptional period risk assessment form, team in line with the current literature, consists of a total of 45 closed-ended questions. The form, which was finalised as a result of expert evaluations, is in the process of publication

    Measured: baseline (pre intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2024
  2. Study start15 Feb 2024 (estimated)
  3. Primary completion15 Jul 2025 (estimated)
  4. Study completion15 Aug 2025 (estimated)

Resources

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
Randomised
Intervention model
Crossover
Model description
We do not use a model
Masking
Single blind
Who is masked
Participant
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06272188
Sponsor's protocol ID
09.2023.1435
Status last verified
Feb 2024
First submitted
10 Jan 2024
Last updated
22 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing web-based online preconceptional counselling in people with Preconception Care, Preconception Risk, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).

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 8 inclusion and 8 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 22 Feb 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 Turkey (Türkiye). 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 esra sari (+905459027677, esrasari87@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Identifying Information Form (time frame: baseline (pre intervention)). 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 22 Feb 2024.

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