NCT03838887

Brief Summary

• Preeclampsia is a multisystem disorder that can cause considerable maternal and fetal morbidity and mortality. Late preeclampsia (with delivery \>34 weeks) is more frequent and less serious than early preeclampsia (with delivery \<34 weeks). Poor early placentation has been especially associated with early disease. Early identification of women at risk of preeclampsia is currently a crucial aim of antenatal care since they may benefit from prophylactic treatment and increased surveillance.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 12, 2019

Completed
2.3 years until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

August 18, 2021

Status Verified

August 1, 2021

Enrollment Period

6 months

First QC Date

February 3, 2019

Last Update Submit

August 11, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • placental vascular indices in prediction of preeclampsia

    placental vascular indices in prediction of preeclampsia compared to uterine artery doppler in prediction of preeclampsia

    one year

Study Arms (2)

control group

Pregnant women: 1. Age between 18-35 years 2. Parity: primigravidas and multiparas. 3. Have no history of preeclampsia or eclampsia. 4. Have no history of chronic hypertension. 5. Not diabetic. 6. Not have antiphospholipid syndrome. 7. Not have autoimmune disease such as SLE

Device: ultrasound machine

High risk group

Pregnant women with: 1. History of preeclampsia -Eclapmsia 2. Chronic hypertension 3. Diabetic 4. Antiphospholipid syndrome. 5. Autoimmune syndrome such as SLE.

Device: ultrasound machine

Interventions

Ultrasound machine with a vocal software

High risk groupcontrol group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsexamination of pregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

All pregnant women will be examined for antenatal care in the outpatient clinic and fetal medicine unit of obstetrics and gynecology department then they will be divided into two groups control and high risk

You may qualify if:

  • A. Control group: Pregnant women:
  • Age between 18-35 years
  • Parity: primigravidas and multiparas.
  • Have no history of preeclampsia or eclampsia.
  • Have no history of chronic hypertension.
  • Not diabetic.
  • Not have antiphospholipid syndrome.
  • Not have autoimmune disease such as SLE.
  • B. High risk group: Pregnant women with:
  • History of preeclampsia -Eclapmsia
  • Chronic hypertension
  • Diabetic
  • Antiphospholipid syndrome.
  • Autoimmune syndrome such as SLE.

You may not qualify if:

  • Smoking
  • Dichorionic placentae
  • Fetal anomaly
  • Uterine fibroid at the site of placental implantation
  • Subchorionic hematoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Research Centre

Cairo, 1234, Egypt

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

SHERIF MOHAMMED ELSIRGANY, DOCTOR

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher ,Family Planning and Reproductive Health Department

Study Record Dates

First Submitted

February 3, 2019

First Posted

February 12, 2019

Study Start

June 1, 2021

Primary Completion

December 1, 2021

Study Completion

January 1, 2022

Last Updated

August 18, 2021

Record last verified: 2021-08

Locations