High Risk PregnancyNCT06130150
Sexual Function in High-risk Pregnant Women
An observational study of High Risk Pregnancy and Sexual Dysfunction, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
Our aim with this study is to evaluate the sexual functions of pregnant women whose pregnancies are defined as high-risk pregnancies and whose pregnancies are followed by perinatology specialists. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- High Risk Pregnancy, Sexual Dysfunction, Anxiety
- How many people
- 400 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2021to Jan 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women between the ages of 18-40 who were diagnosed with risky pregnancy for any reason during their pregnancy.
Inclusion Criteria: - Pregnant women over 18 years old, -Pregnant women 39 years old and under, -Pregnant women in their 3rd trimester.
Exclusion Criteria: - Pregnant women under 18 years old, -Pregnant women over 40 years old, -Pregnant women in their 1st or 2nd trimester.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Prof. Dr. Cemil Tascioglu City Hospital
Istanbul, Sisli, 34384
Aylin Ozkahraman, MD, +905069123510, aylinozkahraman@icloud.com
About this study
Official title: Evaluation of Sexual Function in High-risk Pregnant Women
Our aim with this study is to evaluate the sexual functions of pregnant women whose pregnancies are defined as high-risk pregnancies and whose pregnancies are followed by perinatology specialists.
- Keywords
- high-risk pregnancy, perinatology, sexual dysfunction, female sexual function, fsfi
- Medical subject headings
- Sexual Dysfunction, Physiological, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High-risk | This group includes pregnant women with the risk factors determined in the study | |
| Normal | This group includes pregnant women with no risk |
What is being measured
The primary outcome is the main question the study is designed to answer.
1
High-risk pregnant women have lower FSFI score results then normal pregnant women
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start10 Jul 2021
- Primary completion10 Jan 2022
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk PregnancyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cagdas Nurettin Emeklioglu, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06130150
- Sponsor's protocol ID
- KBU-EMEKLIOGLU-002
- Status last verified
- Nov 2023
- First submitted
- 8 Nov 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sexual Function in High-risk Pregnant Women
- ClinicalTrials.gov ID
- NCT06130150
- Acronym / sponsor ID
- KBU-EMEKLIOGLU-002
- Keywords
- high-risk pregnancy, perinatology, sexual dysfunction, female sexual function, fsfi
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 10 Jul 2021 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- Jan 2024 (estimated)
- First posted
- 14 Nov 2023 (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.
Our aim with this study is to evaluate the sexual functions of pregnant women whose pregnancies are defined as high-risk pregnancies and whose pregnancies are followed by perinatology specialists.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-risk | – | –This group includes pregnant women with the risk factors determined in the study |
| Normal | – | –This group includes pregnant women with no risk |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women between the ages of 18-40 who were diagnosed with risky pregnancy for any reason during their pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1
Time frame: 1 day
High-risk pregnant women have lower FSFI score results then normal pregnant women
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
Related trials for High Risk Pregnancy
RecruitingPhase 3
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Chronic Kidney Disease and Hypertension
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma
Recruiting
Unravelling Tumour Biology In Ovarian Cancer With Precision Imaging
High Grade Serous Ovarian Cancer
RecruitingPhase 2
Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer
Ovarian Cancer
RecruitingPhase 3
Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
Postpartum Hemorrhage
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Risk Pregnancy and Sexual Dysfunction, run by Karabuk 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?
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 14 Nov 2023. 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 Cagdas Nurettin Emeklioglu, MD (+905359129913, c.n.emeklioglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 (time frame: 1 day). 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 14 Nov 2023.