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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-35
SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women aged from 20-35 years.

Pregnant women from 28-30 weeks.

Pregnant women with a singleton pregnancy.

Women with chronic or gestational hypertension.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Anti-Hypertensive

    Drug

    For control of the blood pressure

  • Ultrasound

    Radiation

    For assessment of gestational age and fetal weight

  • Doppler ultrasound

    Radiation

    Umbilical artery Doppler assessment

  • complete blood count

    Diagnostic test

    For assessment of platelet count

  • Body mass index

    Diagnostic test

    for assessment of maternal weight during pregnancy

Treatment groups

260 Participants
are divided into 2 treatment groups
Group A: Non-obese hypertensive pregnant womenOther 5 interventions
Group B: Obese hypertensive pregnant womenOther 5 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
3 month

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: