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Ambulatory Blood Pressure Monitoring in Post-Partum Pre-Eclamptic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02943122
Recruitment Status : Unknown
Verified October 2016 by Ahmed Mohamed Abbas, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : October 24, 2016
Last Update Posted : October 24, 2016
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed Abbas, Assiut University

Tracking Information
First Submitted Date October 21, 2016
First Posted Date October 24, 2016
Last Update Posted Date October 24, 2016
Study Start Date December 2016
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 21, 2016)
number of women with persistent hypertension [ Time Frame: 6 months ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Ambulatory Blood Pressure Monitoring in Post-Partum Pre-Eclamptic Patients
Official Title Prognostic Value of Ambulatory Blood Pressure Monitoring Pattern in Post-Partum Pre-Eclamptic Patients
Brief Summary Preeclamptic pregnancy is associated with alterations in the left ventricular structure and function and elevation of cardiovascular biomarkers. The alterations are still persistent several months after delivery and are more clearly observed in early-onset and severe Pre-eclampsia
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population all women suffered from preeclampsia in last pregnancy will be examined 3 months after delivery /or termination
Condition Decrease Maternal Morbidity
Intervention Device: Ambulatory blood pressure monitor
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: October 21, 2016)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2018
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All previously healthy women who were diagnosed as preeclampsia.( defined as gestational hypertension ( systolic BP of at least 140 mm Hg and/or a diastolic BP of at least 90 mm Hg on at least two occasions at least 6 hours apart after the 20th week of gestation in women known to be normotensive before pregnancy and before 20 weeks' gestation ) plus proteinuria (300 mg or more per 24-hour period)

Exclusion Criteria:

  • Current pregnancy
  • Chronic hypertension or any condition requiring the use of antihypertensive medication
  • Chronic kidney disease
  • Any disease requiring the use of anti-inflammatory medication, diabetes or any other endocrine disease such as hyperthyroidism
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT02943122
Other Study ID Numbers ABPM
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Ahmed Mohamed Abbas, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators Not Provided
PRS Account Assiut University
Verification Date October 2016