Ambulatory Blood Pressure Monitoring in Post-Partum Pre-E... | NCT02943122

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

NCT02943122

Sponsor

Assiut University

Status

Completed

Last Update Posted

May 13, 2020Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Decrease Maternal Morbidity

Interventions

Ambulatory blood pressure monitor

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2016Actual

Primary Completion Date

Aug 31, 2019Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

Oct 21, 2016

First Submission Date that Met QC Criteria

Oct 21, 2016

First Posted Date

Oct 24, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 11, 2020

Last Update Posted Date

May 13, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Name	Type	Description	Arm Group Labels	Other Names
Ambulatory blood pressure monitor	Device

Measure	Description	Time Frame
number of women with persistent hypertension		6 months

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

all women suffered from preeclampsia in last pregnancy will be examined 3 months after delivery /or termination

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ahmed Abbas		Assiut	Cairo Governorate	002	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided