HypertensionWAPA-PregnanNCT06248463
Blood Pressure Assessment in Waiting Room During Pregnancy
An observational study of Hypertension and Pregnancy Induced Hypertension, run by Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura.
Trial summary
The goal of this observational study is to compare in healthy pregnant women during the first trimester. The main question it aims to answer are: Accuracy of measuring automatically Blood Pressure (BP) at appointment compared to 24 Hour Ambulatory Blood Pressure Monitor (ABPM). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Pregnancy Induced Hypertension
- What is being tested?
- BP measurement in waiting room for 20 minutes
- How many people
- 659 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 1 Jul 2026
- How long will I take part?
- 10 Months
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women with suspected hypertension
Who may be able to join
- Woman during the first 12 weeks of pregnancy Maternal age>35 Nulliparity Previous history of hypertension Short and long interpregnancy interval Use of assisted reproductive technologies Family history of preeclampsia Obesity. BMI>30. Hyperglycemia Renal disease
Who cannot join
- Any inability to perform 24-h ambulatory BP measurement
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Automatic Blood Pressure Assessment in Waiting Room During Pregnancy Compare to 24-h Ambulatory Blood Pressure Measurement
The goal of this observational study is to compare in healthy pregnant women during the first trimester. The main question it aims to answer are:
Accuracy of measuring automatically Blood Pressure (BP) at appointment compared to 24 Hour Ambulatory Blood Pressure Monitor (ABPM).
Participants will be BP measured with homologated device every 3 minutes in waiting room for 20 minutes.
Researchers will compare Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in clinical visit to see if are comparable to ABPM.
Read the detailed description
659 pregnant women will be recruitment if they In with SBP readings above 130 mmHg in office or the presence of a risk factor for eclampsia: (hypertensive disease in previous pregnancy, chronic hypertension, chronic renal disease, diabetes mellitus, or autoimmune disease) or any two moderate-risk factors (nulliparity, age ≥40 years, BMI ≥35 kg/m2, family history of PE, or interpregnancy interval >10 years).
Measured of BP will be performance in waiting room for 20 minutes every 3 minutes and report by an mobile app. After 24h-ABPM device will be implanted. Results of SBP and DBP obtained in office will be compared with 24-h, diurnal and nocturnal SBP/DBP mean.
BP will be measured automatically and repeatedly every 3 minutes in the waiting room for 20 minutes. Subsequently, a SpaceLab ABPM monitor will be implanted. The SBP and DBP results obtained in the waiting room will be compared with the ABPM results.
Clinical data related to eclampsia and maternal and newborn pregnancy outcomes will be collected from all patients.
- Conditions
- Hypertension, Pregnancy Induced Hypertension
- Being tested
- BP measurement in waiting room for 20 minutes
- Keywords
- Hypertension in pregnancy., Blood Pressure measurement.
- Medical subject headings
- Hypertension, Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BP measurement in waiting room for 20 minutesDiagnostic test
Also called ABPM-24 h
Measured of BP will be performance in waiting room for 20 minutes every 3 minutes and report by an mobile app. After 24h-ABPM device will be implanted. Results of SBP and DBP obtained in office will be compared with 24-h, diurnal and nocturnal SBP/DBP mean.
BP will be measured automatically and repeatedly every 3 minutes in the waiting room for 20 minutes. Subsequently, a SpaceLab ABPM monitor will be implanted.
| Study group | Role | What they receive |
|---|---|---|
| Woman with hypertension risk related to gestation | SBP readings above 130 mmHg in office or the presence of a risk factor for eclampsia: (hypertensive disease in previous pregnancy, chronic hypertension, chronic renal disease, diabetes mellitus, or autoimmune disease) or any two moderate-risk factors (nulliparity, age ≥40 years, BMI ≥35 kg/m2, family history of PE, or interpregnancy interval >10 years) Receives: Diagnostic Test: BP measurement in waiting room for 20 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in Blood Pressure between office and 24- Ambulatory Blood Pressure Meassurement (24-h ABPM)
Concordance of Systolic and Diastolic Blood Pressure mean between waiting room and 24-h ABMP measurements
Measured: 10 mounths
Maternal
Cardiovascular events, preeclampsia, abruptio, cesarean delivery, hemorrhage,pulmonary edema, death
Measured: 10 months
Newborn
Growth restriction, preterm delivery, congenital anomalies, stillbirth, neonatal death.
Measured: 10 monts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start1 Nov 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 659 participants (estimated)
- Target duration
- 10 Months
Sponsor and investigators
- Lead sponsor
- Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura
- Sponsor type
- University, hospital or other
- Collaborators
- University of Salamanca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06248463
- Sponsor's protocol ID
- FUNDESALUD
- Acronym
- WAPA-Pregnan
- Status last verified
- Jan 2024
- First submitted
- 31 Jan 2024
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automatic Blood Pressure Assessment in Waiting Room During Pregnancy Compare to 24-h Ambulatory Blood Pressure Measurement
- ClinicalTrials.gov ID
- NCT06248463
- Acronym / sponsor ID
- WAPA-Pregnan / FUNDESALUD
- Conditions
- Hypertension, Pregnancy Induced Hypertension
- Keywords
- Hypertension in pregnancy., Blood Pressure measurement.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 659 participants (estimated)
- Lead sponsor
- Fundación para la Formación e Investigación de los Profesionales de la Salud de ExtremaduraUniversity, hospital or other
- Collaborators
- University of Salamanca
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 8 Feb 2024 (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 goal of this observational study is to compare in healthy pregnant women during the first trimester. The main question it aims to answer are:
Accuracy of measuring automatically Blood Pressure (BP) at appointment compared to 24 Hour Ambulatory Blood Pressure Monitor (ABPM).
Participants will be BP measured with homologated device every 3 minutes in waiting room for 20 minutes.
Researchers will compare Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in clinical visit to see if are comparable to ABPM.
Detailed description
659 pregnant women will be recruitment if they In with SBP readings above 130 mmHg in office or the presence of a risk factor for eclampsia: (hypertensive disease in previous pregnancy, chronic hypertension, chronic renal disease, diabetes mellitus, or autoimmune disease) or any two moderate-risk factors (nulliparity, age ≥40 years, BMI ≥35 kg/m2, family history of PE, or interpregnancy interval >10 years).
Measured of BP will be performance in waiting room for 20 minutes every 3 minutes and report by an mobile app. After 24h-ABPM device will be implanted. Results of SBP and DBP obtained in office will be compared with 24-h, diurnal and nocturnal SBP/DBP mean.
BP will be measured automatically and repeatedly every 3 minutes in the waiting room for 20 minutes. Subsequently, a SpaceLab ABPM monitor will be implanted. The SBP and DBP results obtained in the waiting room will be compared with the ABPM results.
Clinical data related to eclampsia and maternal and newborn pregnancy outcomes will be collected from all patients.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 10 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Woman with hypertension risk related to gestation | – | Diagnostic Test: BP measurement in waiting room for 20 minutesSBP readings above 130 mmHg in office or the presence of a risk factor for eclampsia: (hypertensive disease in previous pregnancy, chronic hypertension, chronic renal disease, diabetes mellitus, or autoimmune disease) or any two moderate-risk factors (nulliparity, age ≥40 years, BMI ≥35 kg/m2, family history of PE, or interpregnancy interval >10 years) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women with suspected hypertension
Key inclusion criteria (1 listed)
- Woman during the first 12 weeks of pregnancy Maternal age>35 Nulliparity Previous history of hypertension Short and long interpregnancy interval Use of assisted reproductive technologies Family history of preeclampsia Obesity. BMI>30. Hyperglycemia Renal disease
Key exclusion criteria (1 listed)
- Any inability to perform 24-h ambulatory BP measurement
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 |
|---|---|---|
| BP measurement in waiting room for 20 minutesAlso: ABPM-24 hMeasured of BP will be performance in waiting room for 20 minutes every 3 minutes and report by an mobile app. After 24h-ABPM device will be implanted. Results of SBP and DBP obtained in office will be compared with 24-h, diurnal and nocturnal SBP/DBP mean. BP will be measured automatically and repeatedly every 3 minutes in the waiting room for 20 minutes. Subsequently, a SpaceLab ABPM monitor will be implanted. | Diagnostic test | Woman with hypertension risk related to gestation |
Primary outcome
Differences in Blood Pressure between office and 24- Ambulatory Blood Pressure Meassurement (24-h ABPM)
Time frame: 10 mounths
Concordance of Systolic and Diastolic Blood Pressure mean between waiting room and 24-h ABMP measurements
Maternal
Time frame: 10 months
Cardiovascular events, preeclampsia, abruptio, cesarean delivery, hemorrhage,pulmonary edema, death
Newborn
Time frame: 10 monts
Growth restriction, preterm delivery, congenital anomalies, stillbirth, neonatal death.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Pregnancy Induced Hypertension, run by Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura.
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 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact JUAN F SANCHEZ MUÑOZ-TORRERO, MD (0034656259939, juanf.sanchezm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in Blood Pressure between office and 24- Ambulatory Blood Pressure Meassurement (24-h ABPM) (time frame: 10 mounths). The study lists 3 primary outcomes in all. 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 12 Feb 2024.