NCT04389489

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

May 14, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 15, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2020

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

March 30, 2023

Status Verified

March 1, 2023

Enrollment Period

4 months

First QC Date

May 14, 2020

Last Update Submit

March 28, 2023

Conditions

Keywords

Postpartum PeriodDyspareuniaCOVID-19

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (1)

  • Evaluation of pregnant women diagnosed with COVID-19 using Carol Postpartum Sexual Function and Dyspareunia Scale

    3 Months

Study Arms (2)

COVID-19

Pregnant women with COVID-19 who have given birth

Control

Healthy pregnant women who have given birth

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • Pregnant Patient with COVID-19

You may not qualify if:

  • Those with known sexual dysfunction disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Halkali, 34307, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 29277039BACKGROUND

MeSH Terms

Conditions

COVID-19Dyspareunia

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGenital Diseases, MaleSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist of Obstetrics and Gynecology

Study Record Dates

First Submitted

May 14, 2020

First Posted

May 15, 2020

Study Start

May 14, 2020

Primary Completion

September 25, 2020

Study Completion

September 30, 2020

Last Updated

March 30, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations