Hypertension in PregnancyNCT05673135
The Outcomes of Hypertension in Obese Versus Non-obese Pregnant Women
A study testing Anti-Hypertensive, Ultrasound and Doppler ultrasound in people with Hypertension in Pregnancy, run by Assiut University at 1 site in Egypt.
Trial summary
Hypertensive disorders of pregnancy, include pre-existing and gestational hypertension, preeclampsia, and eclampsia, it complicates up to 10% of pregnancies and represents a significant cause of maternal and perinatal morbidity and mortality. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Hypertension in Pregnancy
- What is being tested?
- Anti-Hypertensive, Ultrasound and Doppler ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to Oct 2026
- Phase
- Interventional
- 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 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged from 20-35 years.
- Pregnant women from 28-30 weeks.
- Pregnant women with a singleton pregnancy.
- Women with chronic or gestational hypertension.
- Women with normal baseline investigations (uncomplicated hypertension).
- Obese women and non-obese women.
Who cannot join
- Women with preeclampsia/eclampsia.
- Women need urgent termination of pregnancy.
- Women with co-morbidities such as diabetes, renal diseases, cardiac ...etc.
- Women with confirmed fetal malformation.
- Women who will refuse to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Differences in Adverse Maternal and Fetal Outcomes Related to Hypertension in Obese Versus Non-obese Pregnant Women
Hypertensive disorders of pregnancy, include pre-existing and gestational hypertension, preeclampsia, and eclampsia, it complicates up to 10% of pregnancies and represents a significant cause of maternal and perinatal morbidity and mortality. Following the "National High Blood Pressure Education Program Working Group on High Blood Pressure in Pregnancy" recommendation is currently a systolic blood pressure (SBP) ⩾ of 140 mmHg and diastolic blood pressure (DBP) ⩾ of 90 mmHg. The diagnosis generally requires two separate measurements. Accepted across international guidelines are the following four categories: Chronic/pre-existing hypertension (Hypertension discovered preconception or prior to 20 weeks gestation), Gestational hypertension (Hypertension that appears de novo after 20 weeks gestation and normalizes after pregnancy), Preeclampsia-eclampsia (De novo hypertension after 20 weeks' gestation accompanied by proteinuria, other features of maternal organ dysfunction or uteroplacental dysfunction), Chronic/pre-existing hypertension with superimposed preeclampsia-eclampsia. Over the past 2 decades, extensive epidemiologic studies have clearly established that obesity is a major risk for gestational hypertension and preeclampsia. The risk of preeclampsia typically doubles with each 5-7 kg/m2 increase in pre-pregnancy. The mechanisms have only been partially explored; increased cytokine-mediated inflammation and oxidative stress, increased shear stress, dyslipidemia, and increased sympathetic activity1 have all been proposed as possible pathways. Few studies have examined the relationship between pre-pregnancy BMI, gestational weight gain (GWG), and the risk of preeclampsia. So, our study aims to evaluate the adverse maternal and fetal outcomes related to hypertension in obese and non-obese pregnant women.
- Conditions
- Hypertension in Pregnancy
- Being tested
- Anti-Hypertensive, Ultrasound, Doppler ultrasound, complete blood count, Body mass index
- 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.
Anti-HypertensiveDrug
For control of the blood pressure
UltrasoundRadiation
For assessment of gestational age and fetal weight
Doppler ultrasoundRadiation
Umbilical artery Doppler assessment
complete blood countDiagnostic test
For assessment of platelet count
Body mass indexDiagnostic test
for assessment of maternal weight during pregnancy
| Study group | Role | What they receive |
|---|---|---|
| Non-obese hypertensive pregnant women | Other | Not described Receives: Drug: Anti-Hypertensive; Radiation: Ultrasound; Radiation: Doppler ultrasound; Diagnostic Test: complete blood count; Diagnostic Test: Body mass index |
| Obese hypertensive pregnant women | Other | Not described Receives: Drug: Anti-Hypertensive; Radiation: Ultrasound; Radiation: Doppler ultrasound; Diagnostic Test: complete blood count; Diagnostic Test: Body mass index |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of adverse maternal outcome related to hypertension in both groups
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start1 Apr 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension in PregnancyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Khairy Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673135
- Sponsor's protocol ID
- HT-pre
- Status last verified
- Apr 2024
- First submitted
- 1 Jan 2023
- Last updated
- 24 Apr 2024
- 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 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Differences in Adverse Maternal and Fetal Outcomes Related to Hypertension in Obese Versus Non-obese Pregnant Women
- ClinicalTrials.gov ID
- NCT05673135
- Acronym / sponsor ID
- HT-pre
- Conditions
- Hypertension in Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 6 Jan 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.
Hypertensive disorders of pregnancy, include pre-existing and gestational hypertension, preeclampsia, and eclampsia, it complicates up to 10% of pregnancies and represents a significant cause of maternal and perinatal morbidity and mortality. Following the "National High Blood Pressure Education Program Working Group on High Blood Pressure in Pregnancy" recommendation is currently a systolic blood pressure (SBP) ⩾ of 140 mmHg and diastolic blood pressure (DBP) ⩾ of 90 mmHg. The diagnosis generally requires two separate measurements. Accepted across international guidelines are the following four categories: Chronic/pre-existing hypertension (Hypertension discovered preconception or prior to 20 weeks gestation), Gestational hypertension (Hypertension that appears de novo after 20 weeks gestation and normalizes after pregnancy), Preeclampsia-eclampsia (De novo hypertension after 20 weeks' gestation accompanied by proteinuria, other features of maternal organ dysfunction or uteroplacental dysfunction), Chronic/pre-existing hypertension with superimposed preeclampsia-eclampsia. Over the past 2 decades, extensive epidemiologic studies have clearly established that obesity is a major risk for gestational hypertension and preeclampsia. The risk of preeclampsia typically doubles with each 5-7 kg/m2 increase in pre-pregnancy. The mechanisms have only been partially explored; increased cytokine-mediated inflammation and oxidative stress, increased shear stress, dyslipidemia, and increased sympathetic activity1 have all been proposed as possible pathways. Few studies have examined the relationship between pre-pregnancy BMI, gestational weight gain (GWG), and the risk of preeclampsia. So, our study aims to evaluate the adverse maternal and fetal outcomes related to hypertension in obese and non-obese pregnant women.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-obese hypertensive pregnant women | Other | Drug: Anti-Hypertensive, Radiation: Ultrasound, Radiation: Doppler ultrasound, Diagnostic Test: complete blood count, Diagnostic Test: Body mass index |
| Obese hypertensive pregnant women | Other | Drug: Anti-Hypertensive, Radiation: Ultrasound, Radiation: Doppler ultrasound, Diagnostic Test: complete blood count, Diagnostic Test: Body mass index |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women aged from 20-35 years.
- Pregnant women from 28-30 weeks.
- Pregnant women with a singleton pregnancy.
- Women with chronic or gestational hypertension.
- Women with normal baseline investigations (uncomplicated hypertension).
Key exclusion criteria (5 listed)
- Women with preeclampsia/eclampsia.
- Women need urgent termination of pregnancy.
- Women with co-morbidities such as diabetes, renal diseases, cardiac ...etc.
- Women with confirmed fetal malformation.
- Women who will refuse to participate.
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 |
|---|---|---|
| Anti-HypertensiveFor control of the blood pressure | Drug | Non-obese hypertensive pregnant women, Obese hypertensive pregnant women |
| UltrasoundFor assessment of gestational age and fetal weight | Radiation | Non-obese hypertensive pregnant women, Obese hypertensive pregnant women |
| Doppler ultrasoundUmbilical artery Doppler assessment | Radiation | Non-obese hypertensive pregnant women, Obese hypertensive pregnant women |
| complete blood countFor assessment of platelet count | Diagnostic test | Non-obese hypertensive pregnant women, Obese hypertensive pregnant women |
| Body mass indexfor assessment of maternal weight during pregnancy | Diagnostic test | Non-obese hypertensive pregnant women, Obese hypertensive pregnant women |
Primary outcome
The rate of adverse maternal outcome related to hypertension in both groups
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- 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?
A study testing Anti-Hypertensive, Ultrasound and Doppler ultrasound in people with Hypertension in Pregnancy, run by Assiut University at 1 site in Egypt.
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 6 inclusion and 5 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 24 Apr 2024. 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 Egypt. 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?
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?
The rate of adverse maternal outcome related to hypertension in both groups (time frame: 3 month). 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 24 Apr 2024.