Preconception Care for Couples Planning Pregnancy

NCT06272188 | Not Yet Recruiting

• 1 other identifier: 09.2023.1435
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Preconception Care, Preconception Risk

Keywords

Preconceptional care; Preconceptional risk factors; Online counseling; Nursing

Outcome Measures

Primary Outcomes (1)

• Identifying Information Form

  Participants will receive web-based online preconceptional counseling.

  baseline (pre intervention)

Secondary Outcomes (1)

• Preconceptional Period Risk Assessment Form

  baseline (pre intervention)

Other Outcomes (2)

• Preconceptional Care Health Literacy Scale

  Data will be collected before preconception counselling (intervention) and three months after preconception counselling. Data will be reported no later than September 1, 2025.

• Preconceptional Period Health Behavior Scale

  The preconceptional Period Health Behavior Scale will be used to collect data during the pre-intervention phase and the third month after the intervention.

Study Arms (2)

Experimantal group

EXPERIMENTAL

Couples 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.

Other: web-based online preconceptional counselling

Control group

NO INTERVENTION

No 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.

Interventions

web-based online preconceptional counselling OTHER

web-based online preconceptional counselling

Experimantal group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yuzuncu Yil University: lead
• Marmara University: collaborator
• Kocaeli University: collaborator
• Kastamonu University: collaborator
• Maltepe University: collaborator
• Izmir Katip Celebi University: collaborator

Study Sites (1)

Van Yuzuncu Yil University

Van, Turkey (Türkiye)

Location

Study Officials

• Ozlem Can Gurkan

  Marmara University

  STUDY DIRECTOR

• Eda Simsek Sahin

  Kocaeli University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

esra sari

CONTACT

+905459027677; esrasari87@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asist Prof.

Model Details: We do not use a model

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: February 22, 2024
• Study Start: February 15, 2024
• Primary Completion: July 15, 2025
• Study Completion: August 15, 2025
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)