COVID-19NCT04389489
Postpartum Sexual Function in Pregnant Women With COVID-19
An observational study of COVID-19 and Dyspareunia, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to identify women with postpartum sexual dysfunction and dyspareunia risk in the early period and to use the treatment and care services they need effectively. 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
- COVID-19, Dyspareunia, Postpartum Period
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 May 2020to 30 Sep 2020
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: In the reproductive age between 18-45 years old, two groups of 70 people will be selected, consisting of puerperant diagnosed with COVID-19 and healthy puerperant. Patients who have cesarean or vaginal delivery at the end of the study group, who do not have sexual intercourse dysfunction for another reason (such as Stage 3-4 perineal injury, vaginismus) will be selected.
Who may be able to join
- Pregnant Patient with COVID-19
Who cannot join
- Those with known sexual dysfunction disorder
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, Halkali, 34307
About this study
Official title: Evaluation of Pregnant Women Diagnosed With COVID-19 Using Carol Postpartum Sexual Function and Dyspareunia Scale
The aim of this study is to identify women with postpartum sexual dysfunction and dyspareunia risk in the early period and to use the treatment and care services they need effectively. Our secondary aim is to reveal the difference in sexual life in the postpartum period between healthy pregnant women and pregnant women diagnosed with COVID-19.
- Conditions
- COVID-19, Dyspareunia, Postpartum Period
- Keywords
- Postpartum Period, Dyspareunia, COVID-19
- Medical subject headings
- COVID-19, Dyspareunia
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 |
|---|---|---|
| COVID-19 | Pregnant women with COVID-19 who have given birth | |
| Control | Healthy pregnant women who have given birth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of pregnant women diagnosed with COVID-19 using Carol Postpartum Sexual Function and Dyspareunia Scale
In the study planned to be carried out, it is aimed to identify women at risk of postpartum sexual dysfunction and dyspareunia early and benefit from the treatment and care services they need effectively.
Measured: 3 months
Secondary outcomes (1)
Evaluation of pregnant women diagnosed with COVID-19 using Carol Postpartum Sexual Function and Dyspareunia Scale
To reveal the difference in sexual life in postpartum period between healthy pregnant women and pregnant women diagnosed with COVID-19.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start14 May 2020
- Primary completion25 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Aldikactioglu Talmac, MD, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04389489
- Sponsor's protocol ID
- MTalmacCarol
- Status last verified
- Mar 2023
- First submitted
- 14 May 2020
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lopez-Lapeyrere C, Serna-Gomez N, Hernandez-Lopez AB, Perez-Garcia MF, Tejeda-Esteban A, Solis-Munoz M. The development and validation of a new postpartum sexual function and dyspareunia assessment tool: The Carol Scale. Midwifery. 2018 Mar;58:27-36. doi: 10.1016/j.midw.2017.11.008. Epub 2017 Dec 6.
PubMed 29277039
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pregnant Women Diagnosed With COVID-19 Using Carol Postpartum Sexual Function and Dyspareunia Scale
- ClinicalTrials.gov ID
- NCT04389489
- Acronym / sponsor ID
- MTalmacCarol
- Conditions
- COVID-19, Dyspareunia, Postpartum Period
- Keywords
- Postpartum Period, Dyspareunia, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 14 May 2020 (actual)
- Primary completion
- 25 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 15 May 2020 (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 this study is to identify women with postpartum sexual dysfunction and dyspareunia risk in the early period and to use the treatment and care services they need effectively. Our secondary aim is to reveal the difference in sexual life in the postpartum period between healthy pregnant women and pregnant women diagnosed with COVID-19.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 | – | –Pregnant women with COVID-19 who have given birth |
| Control | – | –Healthy pregnant women who have given birth |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- In the reproductive age between 18-45 years old, two groups of 70 people will be selected, consisting of puerperant diagnosed with COVID-19 and healthy puerperant. Patients who have cesarean or vaginal delivery at the end of the study group, who do not have sexual intercourse dysfunction for another reason (such as Stage 3-4 perineal injury, vaginismus) will be selected.
Key inclusion criteria (1 listed)
- Pregnant Patient with COVID-19
Key exclusion criteria (1 listed)
- Those with known sexual dysfunction disorder
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
Evaluation of pregnant women diagnosed with COVID-19 using Carol Postpartum Sexual Function and Dyspareunia Scale
Time frame: 3 months
In the study planned to be carried out, it is aimed to identify women at risk of postpartum sexual dysfunction and dyspareunia early and benefit from the treatment and care services they need effectively.
1 secondary outcome
Evaluation of pregnant women diagnosed with COVID-19 using Carol Postpartum Sexual Function and Dyspareunia Scale
Time frame: 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Background: PubMed 29277039Lopez-Lapeyrere C, Serna-Gomez N, Hernandez-Lopez AB, Perez-Garcia MF, Tejeda-Esteban A, Solis-Munoz M. The development and validation of a new postpartum sexual function and dyspareunia assessment tool: The Carol Scale. Midwifery. 2018 Mar;58:27-36. doi: 10.1016/j.midw.2017.11.008. Epub 2017 Dec 6.
- Individual participant dataSharing planned: No
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
The record lists no contact. Use the official record to reach the sponsor.
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 COVID-19 and Dyspareunia, run by Kanuni Sultan Suleyman Training and Research Hospital 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 1 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: finished, as of the sponsor's last update on 30 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of pregnant women diagnosed with COVID-19 using Carol Postpartum Sexual Function and Dyspareunia Scale (time frame: 3 months). 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 NCT04389489, which also lists 1 linked publication.
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 30 Mar 2023.