CounselingNCT05355636
The Effects of Fertility Management Counseling Supported With Telehealth on Contraceptive Use
A study testing Fertility Management Counseling in people with Counseling and Fertility, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Fertility management refers to the entirety of practices that allow families to have as many children as they want and when they want, prevent unwanted pregnancies, regulate the time between two births and receive help in having children in the case of infertility. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Counseling, Fertility, Contraception
- What is being tested?
- Fertility Management Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 1 Dec 2022
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- volunteer
- be between the ages of 18-45
- to be primiparous
- have a smart phone
- complete education
Who cannot join
- refuse to research
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Duygu Tatar
Bitlis, Bi̇tli̇s, 13000
duygu tatar, +905395788652, dygalan34@gmail.com
About this study
Fertility management refers to the entirety of practices that allow families to have as many children as they want and when they want, prevent unwanted pregnancies, regulate the time between two births and receive help in having children in the case of infertility.
According to the Turkey Demographic and Health Survey 2018 data, 70% of women in Turkey who are currently married do not use any contraceptive method. Based on the same data, the rate of the unmet need for fertility management is 12% nationwide, 14% in eastern provinces, and 17% in women at the ages of 20-24. These rates show that the rates of unmet fertility management needs in Turkey are still not on the desired level.
The fact that eastern provinces of Turkey have the lowest rate of modern contraceptive method use as 43% and a high rate of unmet fertility management needs as 14% suggests that it is needed to increase the effectiveness of fertility management counseling and reach more women. In these eastern provinces, especially women living in rural areas do not have easy access to these services due to the high prevalence of adolescent marriages, lack of transportation opportunities, healthcare personnel and healthcare services, and unpredictable weather conditions.
Read the detailed description
To eliminate these obstacles to a relative extent, fertility management counseling will be provided through using the telehealth method. The World Health Organization states that telehealth practices will make access easier, eliminate geographical obstacles, increase the quality of healthcare, and allow the cost-effective management of the resources of the healthcare sector. The telehealth system increases the quality of healthcare, and thus, it has a significant role in managing the resources of the healthcare sector.
The Participant Information Form created by the researcher based on the review of the relevant literature includes questions about the sociodemographic characteristics of the participants (age, education level, employment status, income level) and pregnancy-related questions. The Contraceptive Method Usage Status Form (for the experimental and control groups) will be utilized to determine the contraceptive methods that are used by women in the 7th month of the postpartum period.The data that will be obtained in the study will be statistically analyzed using the International Business Machines Statistical Package for the Social Sciences Subscription Trial version. The analyses will include independent-samples t-test, ANOVA, and Cochran test. In cases of significant differences identified in ANOVA, Tukey's test will be used to identify the source of the difference in pairwise comparisons. The level of statistical significance is accepted as p<0.05.
- Conditions
- Counseling, Fertility, Contraception, Telehealth
- Being tested
- Fertility Management Counseling
- Keywords
- fertility management, counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fertility Management CounselingBehavioural
counseling
| Study group | Role | What they receive |
|---|---|---|
| experiment group | Experimental | patient receiving counseling Receives: Behavioral: Fertility Management Counseling |
| control group | No intervention | patient without counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Telehealth on Contraceptive Use
The use of birth control methods by the fertility regulation consultancy service offered by Telehealth in postpartum women is a positive indicator of counseling.
Measured: 7 months
Family Planning Method Using Status Form
It is a scale that examines the method use status of the participants after telehealth assisted fertility regulation counseling.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start1 May 2022 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CounselingStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- duygu tatar, MsC Student, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355636
- Sponsor's protocol ID
- contraceptive counseling
- Status last verified
- Mar 2022
- First submitted
- 14 Mar 2022
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Fertility Management Counseling Supported With Telehealth on Contraceptive Use
- ClinicalTrials.gov ID
- NCT05355636
- Acronym / sponsor ID
- contraceptive counseling
- Conditions
- Counseling, Fertility, Contraception, Telehealth
- Keywords
- fertility management, counseling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 2 May 2022 (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.
Fertility management refers to the entirety of practices that allow families to have as many children as they want and when they want, prevent unwanted pregnancies, regulate the time between two births and receive help in having children in the case of infertility.
According to the Turkey Demographic and Health Survey 2018 data, 70% of women in Turkey who are currently married do not use any contraceptive method. Based on the same data, the rate of the unmet need for fertility management is 12% nationwide, 14% in eastern provinces, and 17% in women at the ages of 20-24. These rates show that the rates of unmet fertility management needs in Turkey are still not on the desired level.
The fact that eastern provinces of Turkey have the lowest rate of modern contraceptive method use as 43% and a high rate of unmet fertility management needs as 14% suggests that it is needed to increase the effectiveness of fertility management counseling and reach more women. In these eastern provinces, especially women living in rural areas do not have easy access to these services due to the high prevalence of adolescent marriages, lack of transportation opportunities, healthcare personnel and healthcare services, and unpredictable weather conditions.
Detailed description
To eliminate these obstacles to a relative extent, fertility management counseling will be provided through using the telehealth method. The World Health Organization states that telehealth practices will make access easier, eliminate geographical obstacles, increase the quality of healthcare, and allow the cost-effective management of the resources of the healthcare sector. The telehealth system increases the quality of healthcare, and thus, it has a significant role in managing the resources of the healthcare sector.
The Participant Information Form created by the researcher based on the review of the relevant literature includes questions about the sociodemographic characteristics of the participants (age, education level, employment status, income level) and pregnancy-related questions. The Contraceptive Method Usage Status Form (for the experimental and control groups) will be utilized to determine the contraceptive methods that are used by women in the 7th month of the postpartum period.The data that will be obtained in the study will be statistically analyzed using the International Business Machines Statistical Package for the Social Sciences Subscription Trial version. The analyses will include independent-samples t-test, ANOVA, and Cochran test. In cases of significant differences identified in ANOVA, Tukey's test will be used to identify the source of the difference in pairwise comparisons. The level of statistical significance is accepted as p<0.05.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experiment group | Experimental | Behavioral: Fertility Management Counselingpatient receiving counseling |
| control group | No intervention | –patient without counseling |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- volunteer
- be between the ages of 18-45
- to be primiparous
- have a smart phone
- complete education
Key exclusion criteria (1 listed)
- refuse to research
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 |
|---|---|---|
| Fertility Management Counselingcounseling | Behavioural | experiment group |
Primary outcome
Telehealth on Contraceptive Use
Time frame: 7 months
The use of birth control methods by the fertility regulation consultancy service offered by Telehealth in postpartum women is a positive indicator of counseling.
Family Planning Method Using Status Form
Time frame: 7 months
It is a scale that examines the method use status of the participants after telehealth assisted fertility regulation counseling.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Individual participant dataSharing planned: No
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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.
duygu tatar, MsC Student principal investigator
Marmara 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 Fertility Management Counseling in people with Counseling and Fertility, run by Marmara 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 5 inclusion and 1 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 2 May 2022. 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 Meltem Demirgöz BAL, prof. (+902167775700 ext. 5721, meltem.bal@marmara.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Telehealth on Contraceptive Use (time frame: 7 months). The study lists 2 primary outcomes in all. 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 2 May 2022.