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Not yet recruitingNCT05673135Updated Apr 24, 2024

The Outcomes of Hypertension in Obese Versus Non-obese Pregnant Women

An interventional study of Anti-Hypertensive and Ultrasound in Hypertension in Pregnancy, sponsored by Assiut University. Not yet recruiting at 1 site in Egypt. Open to female participants aged 25 Years to 35 Years. Per ClinicalTrials.gov, last updated 2024-04-24.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2026, 6 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
260
Allocation
Non-randomized
Ages
25 Years to 35 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Hypertension in Pregnancy
03

In context

Hypertension, Pregnancy-Induced

240 studies on the registry are indexed under Hypertension, Pregnancy-Induced; 66 are open to participants now.

This study's planned enrollment of 260 is above the median of 144 across 163 interventional studies indexed under Hypertension, Pregnancy-Induced.

Browse Hypertension, Pregnancy-Induced studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. Women aged from 20-35 years.
  2. Pregnant women from 28-30 weeks.
  3. Pregnant women with a singleton pregnancy.
  4. Women with chronic or gestational hypertension.
  5. Women with normal baseline investigations (uncomplicated hypertension).
  6. Obese women and non-obese women.

Exclusion criteria

Exclusion Criteria:

  1. Women with preeclampsia/eclampsia.
  2. Women need urgent termination of pregnancy.
  3. Women with co-morbidities such as diabetes, renal diseases, cardiac ...etc.
  4. Women with confirmed fetal malformation.
  5. Women who will refuse to participate.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
260 participants (estimated)

Study arms

  • Other
    Non-obese hypertensive pregnant women

    Drug: Anti-Hypertensive · Radiation: Ultrasound · Radiation: Doppler ultrasound · Diagnostic Test: complete blood count · Diagnostic Test: Body mass index

  • Other
    Obese hypertensive pregnant women

    Drug: Anti-Hypertensive · Radiation: Ultrasound · Radiation: Doppler ultrasound · Diagnostic Test: complete blood count · Diagnostic Test: Body mass index

Interventions

  • DrugAnti-Hypertensive

    For control of the blood pressure

  • RadiationUltrasound

    For assessment of gestational age and fetal weight

  • RadiationDoppler ultrasound

    Umbilical artery Doppler assessment

  • Diagnostic testcomplete blood count

    For assessment of platelet count

  • Diagnostic testBody mass index

    for assessment of maternal weight during pregnancy

06

What researchers measure

Primary outcomes

  1. The rate of adverse maternal outcome related to hypertension in both groups

    Time frame: 3 month

07

Study locations

1 site
  • Women Health Hospital - Assiut university
    Assiut, 71111, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05673135
Lead sponsor
Assiut University
Responsible party
Mohammed Khairy Ali (Assistant Professor, Assiut University) — Principal investigator
First posted
Jan 6, 2023
Start date
Apr 1, 2025 (estimated)
Primary completion
Apr 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
Apr 24, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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