Postpartum Sexual Function in Pregnant Women With COVID-19

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ClinicalTrials.gov Identifier: NCT04389489

Recruitment Status : Recruiting

First Posted : May 15, 2020

Last Update Posted : September 2, 2020

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Merve Aldikactioglu Talmac, MD, Kanuni Sultan Suleyman Training and Research Hospital

Study Description

Brief 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. 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.

Condition or disease
COVID-19 Dyspareunia Postpartum Period

Study Design

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Study Type :	Observational
Estimated Enrollment :	140 participants
Observational Model:	Ecologic or Community
Time Perspective:	Prospective
Official Title:	Evaluation of Pregnant Women Diagnosed With COVID-19 Using Carol Postpartum Sexual Function and Dyspareunia Scale
Actual Study Start Date :	May 14, 2020
Estimated Primary Completion Date :	September 25, 2020
Estimated Study Completion Date :	September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care Sexual Problems in Women

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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.

Secondary Outcome Measures :

Evaluation of pregnant women diagnosed with COVID-19 using Carol Postpartum Sexual Function and Dyspareunia Scale [ Time Frame: 3 Months ]
To reveal the difference in sexual life in postpartum period between healthy pregnant women and pregnant women diagnosed with COVID-19.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

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.

Criteria

Inclusion Criteria:

Pregnant Patient with COVID-19

Exclusion Criteria:

Those with known sexual dysfunction disorder

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04389489

Contacts

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Contact: Merve Aldikactioglu Talmac, M.D.	+905325602366	drmrve@hotmail.com

Locations

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Turkey
Kanuni Sultan Suleyman Training and Research Hospital	Recruiting
Istanbul, Halkali, Turkey, 34307
Contact: Merve Aldikactioglu Talmac, M.D. +905325602366 drmrve@hotmail.com

Sponsors and Collaborators

Kanuni Sultan Suleyman Training and Research Hospital

More Information

Publications:

López-Lapeyrere C, Serna-Gómez N, Hernández-López AB, Pérez-García MF, Tejeda-Esteban A, Solís-Muñoz 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.

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Responsible Party:	Merve Aldikactioglu Talmac, MD, Specialist of Obstetrics and Gynecology, Kanuni Sultan Suleyman Training and Research Hospital
ClinicalTrials.gov Identifier:	NCT04389489
Other Study ID Numbers:	MTalmacCarol
First Posted:	May 15, 2020 Key Record Dates
Last Update Posted:	September 2, 2020
Last Verified:	August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Supporting Materials:	Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Merve Aldikactioglu Talmac, MD, Kanuni Sultan Suleyman Training and Research Hospital:


Postpartum Period Dyspareunia COVID-19

Additional relevant MeSH terms:

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Dyspareunia Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Mental Disorders

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