NCT04389515

Brief Summary

The aim of this study is to provide optimum care to postoperative patients diagnosed with COVID-19 (after cesarean) and to help them with recovery, to determine and assist the expectation and satisfaction of pregnant women with COVID-19 regarding prenatal care.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

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
unknown

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

September 2, 2020

Status Verified

August 1, 2020

Enrollment Period

4 months

First QC Date

May 14, 2020

Last Update Submit

August 31, 2020

Conditions

Keywords

COVID-19Prenatal CarePostoperative Care

Outcome Measures

Primary Outcomes (1)

  • Evaluation of pregnant women diagnosed with COVID-19 with "Post-operative Recovery Index" and "Prenatal Care Satisfaction and Patient Expectations Scale"

    The benefit we expect from the study is to be able to provide optimum care to postoperative patients (after cesarean) diagnosed with COVID-19 and to help them with recovery, to identify and assist the expectation and satisfaction of pregnant women with COVID-19 regarding prenatal care.

    3 Months

Secondary Outcomes (1)

  • Evaluation of pregnant women diagnosed with COVID-19 with "Post-operative Recovery Index" and "Prenatal Care Satisfaction and Patient Expectations Scale"

    3 Months

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

As the patient group, two groups of 75 persons, each of whom are between the ages of 18-45 and who are diagnosed with COVID-19 in reproductive age and healthy pregnant women, will be selected. Patients diagnosed with COVID-19 giving birth with cesarean at term and patients who are followed up with COVID-19 diagnosis before the prenatal period will be selected.

You may qualify if:

  • Pregnant patients with COVID-19

You may not qualify if:

  • Patient giving Preterm Labor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Halkali, 34307, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • Omar MA, Schiffman RF, Bingham CR. Development and testing of the patient expectations and satisfaction with prenatal care instrument. Res Nurs Health. 2001 Jun;24(3):218-29. doi: 10.1002/nur.1024.

    PMID: 11526620BACKGROUND
  • Cengiz H, Aygin D. Validity and reliability study of the Turkish version of the Postoperative Recovery Index of patients undergoing surgical intervention. Turk J Med Sci. 2019 Apr 18;49(2):566-573. doi: 10.3906/sag-1806-33.

    PMID: 30893985BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

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, Principal Investigator

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

September 2, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations