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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05673135
Collaborator
(none)
260
1
2
30
8.7

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Anti-Hypertensive
  • Radiation: Ultrasound
  • Radiation: Doppler ultrasound
  • Diagnostic Test: complete blood count
  • Diagnostic Test: Body mass index
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
260 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Differences in Adverse Maternal and Fetal Outcomes Related to Hypertension in Obese Versus Non-obese Pregnant Women
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2025
Anticipated Study Completion Date :
Oct 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Other: Non-obese hypertensive pregnant women

Drug: Anti-Hypertensive
For control of the blood pressure

Radiation: Ultrasound
For assessment of gestational age and fetal weight

Radiation: Doppler ultrasound
Umbilical artery Doppler assessment

Diagnostic Test: complete blood count
For assessment of platelet count

Diagnostic Test: Body mass index
for assessment of maternal weight during pregnancy

Other: Obese hypertensive pregnant women

Drug: Anti-Hypertensive
For control of the blood pressure

Radiation: Ultrasound
For assessment of gestational age and fetal weight

Radiation: Doppler ultrasound
Umbilical artery Doppler assessment

Diagnostic Test: complete blood count
For assessment of platelet count

Diagnostic Test: Body mass index
for assessment of maternal weight during pregnancy

Outcome Measures

Primary Outcome Measures

  1. The rate of adverse maternal outcome related to hypertension in both groups [3 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 35 Years
Sexes Eligible for Study:
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:
  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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Women Health Hospital - Assiut university Assiut Egypt 71111

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohammed Khairy Ali, Assistant Professor, Assiut University
ClinicalTrials.gov Identifier:
NCT05673135
Other Study ID Numbers:
  • HT-pre
First Posted:
Jan 6, 2023
Last Update Posted:
Jan 6, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 6, 2023