NCT01068002

Brief Summary

Cardiovascular \& echocardiographic assessment in pregnant women with hypertension during their pregnancy in comparison to Pregnant normotensive women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

3 years

First QC Date

February 11, 2010

Last Update Submit

February 11, 2020

Conditions

Keywords

Hypertension Pregnancy

Outcome Measures

Primary Outcomes (1)

  • Hypertension impact on cardiovascular echocardiographic parameters and obstetric parameters in pregnant women with or without treatment

    1 year

Secondary Outcomes (1)

  • Primary outcome, Impact of alfa methyl dopa and labetolol on cardiovascular parameters in pregnant women

    1 Year

Study Arms (3)

Control, normotensive, pregnancy

Control, normotensive, pregnancy

hypertension, pregnancy, no treatment

hypertension, pregnancy, no treatment

hypertension, pregnancy, drug treatment

hypertension, pregnancy, drug treatment

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Pregnant Women

You may qualify if:

  • hypertension during pregnancy: Chronic or pregnancy induced

You may not qualify if:

  • Inability to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ha'Emek Medical Center

Afula, 18101, Israel

Location

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Limor I Bushari

    Heart Institute, Ha'Emek Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 11, 2010

First Posted

February 12, 2010

Study Start

June 1, 2009

Primary Completion

June 1, 2012

Study Completion

September 1, 2012

Last Updated

February 12, 2020

Record last verified: 2020-02

Locations