COVID-19NCT04389515
Postoperative Recovery Index, Patient Expectations and Satisfaction With Prenatal Care Instrument in Pregnant Patients With COVID-19
An observational study of COVID-19 and Prenatal Care, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. 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, Prenatal Care, Postoperative Care
- How many people
- 75 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: 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.
Who may be able to join
- Pregnant patients with COVID-19
Who cannot join
- Patient giving Preterm Labor
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, Halkali, 34307
Merve Aldikactioglu Talmac, M.D., +905325602366, drmrve@hotmail.com
About this study
Official title: Evaluation of Pregnant Women Diagnosed With COVID-19 With "Post-operative Recovery Index" and "Prenatal Care Satisfaction and Patient Expectations Scale"
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.
- Conditions
- COVID-19, Prenatal Care, Postoperative Care
- Keywords
- COVID-19, Prenatal Care, Postoperative Care
- Medical subject headings
- COVID-19
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 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.
Measured: 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"
To determine the differences between healthy pregnant women in the control group and pregnant women diagnosed with COVID-19 in the study group in terms of postoperative care and prenatal care expectations.
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 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 75 participants (estimated)
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
- NCT04389515
- Sponsor's protocol ID
- MTalmac3
- Status last verified
- Aug 2020
- First submitted
- 14 May 2020
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 11526620Cengiz 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.
PubMed 30893985
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pregnant Women Diagnosed With COVID-19 With "Post-operative Recovery Index" and "Prenatal Care Satisfaction and Patient Expectations Scale"
- ClinicalTrials.gov ID
- NCT04389515
- Acronym / sponsor ID
- MTalmac3
- Conditions
- COVID-19, Prenatal Care, Postoperative Care
- Keywords
- COVID-19, Prenatal Care, Postoperative Care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 14 May 2020 (actual)
- Primary completion
- 25 Sep 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- 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 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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- Pregnant patients with COVID-19
Key exclusion criteria (1 listed)
- Patient giving Preterm Labor
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 with "Post-operative Recovery Index" and "Prenatal Care Satisfaction and Patient Expectations Scale"
Time frame: 3 Months
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.
1 secondary outcome
Evaluation of pregnant women diagnosed with COVID-19 with "Post-operative Recovery Index" and "Prenatal Care Satisfaction and Patient Expectations Scale"
Time frame: 3 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Background: PubMed 11526620Omar 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.
- Background: PubMed 30893985Cengiz 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.
- Individual participant dataSharing planned: Yes
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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.
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, Turkey (Türkiye)
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 Prenatal Care, 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: status not confirmed, as of the sponsor's last update on 2 Sep 2020. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of pregnant women diagnosed with COVID-19 with "Post-operative Recovery Index" and "Prenatal Care Satisfaction and Patient Expectations 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 NCT04389515, which also lists 2 linked publications.
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 2 Sep 2020.