Pregnancy RelatedNCT05859282
Development and Validation of a Short Tool to Assess the Awareness of Pregnancy-induced Hypertension
An observational study of Pregnancy Related and Hypertension in Pregnancy, run by Georges Hatem at 1 site in Lebanon.
Trial summary
Background: Pregnancy-induced hypertension (PIH) is responsible for most perinatal and fetal mortality. Few programs are patient-centered during pregnancy, increasing the risks of misinformation and misconceptions among pregnant women and, as a result, malpractices. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Hypertension in Pregnancy
- What is being tested?
- Survey
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 135 participants
- Where
- 1 siteLebanon
- Study dates
- 7 Nov 2021to 30 Jun 2022
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women were targeted from five obstetrics and gynecology clinics.
Who may be able to join
- Participants were asked to participate in the study with no criteria based on race, ethnicity, or gestational age.
Who cannot join
- Those with a history of hypertension or pre-eclampsia were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Validation of a Short Tool to Assess the Awareness of Pregnancy-induced Hypertension: A Cross-sectional Study Among Pregnant Women in Lebanon
Background: Pregnancy-induced hypertension (PIH) is responsible for most perinatal and fetal mortality. Few programs are patient-centered during pregnancy, increasing the risks of misinformation and misconceptions among pregnant women and, as a result, malpractices. Objective: This study aims to develop and validate a form to assess the knowledge and attitudes of pregnant women about PIH.
Read the detailed description
Many observational studies explored the awareness of pregnant women of PIH, but no structured tool is available to assess such awareness. During the past two years, education campaigns were postponed and primary care was prioritized. To allow better-informed decisions and targeted actions, this pilot study aims to develop and validate a short form to assess the knowledge and attitudes of pregnant women about pregnancy-induced hypertension. The long-term objective of this study is to provide a practical tool for pregnant women.
- Conditions
- Pregnancy Related, Hypertension in Pregnancy
- Being tested
- Survey
- Medical subject headings
- Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyBehavioural
A short 25-item tool was developed and can be applied in clinics to assess the awareness of pregnancy hypertension.
What is being measured
The primary outcome is the main question the study is designed to answer.
Awareness of hypertensive disorders of pregnancy by developing a 25-item questionnaire
Thirty-six statements were initially provided to which women had to answer either ''yes'', ''No'' or ''I don't Know''. Out of these statements, 25 were retained due to positive inter-item correlation (15 knowledge statements and 10 behavior statements), and the other statements were eliminated one by one after testing for reliability and computing the effect of each statement on the internal consistency.
Measured: 6 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 2023
- Study start7 Nov 2021
- Primary completion27 Feb 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georges Hatem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Georges Hatem, Lebanese University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859282
- Sponsor's protocol ID
- 2D/21/10
- Status last verified
- May 2023
- First submitted
- 4 May 2023
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Short Tool to Assess the Awareness of Pregnancy-induced Hypertension: A Cross-sectional Study Among Pregnant Women in Lebanon
- ClinicalTrials.gov ID
- NCT05859282
- Acronym / sponsor ID
- 2D/21/10
- Conditions
- Pregnancy Related, Hypertension in Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Georges HatemUniversity, hospital or other
- Study start
- 7 Nov 2021 (actual)
- Primary completion
- 27 Feb 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 15 May 2023 (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.
Background: Pregnancy-induced hypertension (PIH) is responsible for most perinatal and fetal mortality. Few programs are patient-centered during pregnancy, increasing the risks of misinformation and misconceptions among pregnant women and, as a result, malpractices. Objective: This study aims to develop and validate a form to assess the knowledge and attitudes of pregnant women about PIH.
Detailed description
Many observational studies explored the awareness of pregnant women of PIH, but no structured tool is available to assess such awareness. During the past two years, education campaigns were postponed and primary care was prioritized. To allow better-informed decisions and targeted actions, this pilot study aims to develop and validate a short form to assess the knowledge and attitudes of pregnant women about pregnancy-induced hypertension. The long-term objective of this study is to provide a practical tool for pregnant women.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women were targeted from five obstetrics and gynecology clinics.
Key inclusion criteria (1 listed)
- Participants were asked to participate in the study with no criteria based on race, ethnicity, or gestational age.
Key exclusion criteria (1 listed)
- Those with a history of hypertension or pre-eclampsia were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyA short 25-item tool was developed and can be applied in clinics to assess the awareness of pregnancy hypertension. | Behavioural | – |
Primary outcome
Awareness of hypertensive disorders of pregnancy by developing a 25-item questionnaire
Time frame: 6 months
Thirty-six statements were initially provided to which women had to answer either ''yes'', ''No'' or ''I don't Know''. Out of these statements, 25 were retained due to positive inter-item correlation (15 knowledge statements and 10 behavior statements), and the other statements were eliminated one by one after testing for reliability and computing the effect of each statement on the internal consistency.
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 15 May 2023.
- Individual participant dataSharing planned: Undecided
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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.
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 Pregnancy Related and Hypertension in Pregnancy, run by Georges Hatem at 1 site in Lebanon.
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 15 May 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 Lebanon. 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?
Awareness of hypertensive disorders of pregnancy by developing a 25-item questionnaire (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2023.