Ultrasonographic Evaluation of Fetal Adrenal Gland in Cas... | NCT03251794

Studies
Ultrasonographic Evaluation of Fetal Adrenal Gland in Cases of Threatened Preterm Labor

NCT03251794

Sponsor

Assiut University

Status

Completed

Last Update Posted

Jun 27, 2018Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Preterm Labor

Interventions

three dimensional ultrasound
color Doppler

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

Jun 2018

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

Mar 1, 2017Actual

Primary Completion Date

Mar 15, 2018Actual

Completion Date

Apr 18, 2018Actual

First Submitted Date

Aug 13, 2017

First Submission Date that Met QC Criteria

Aug 13, 2017

First Posted Date

Aug 16, 2017Actual

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

Jun 26, 2018

Last Update Posted Date

Jun 27, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Preterm birth continues to be a major public health problem with lasting family and societal repercussions. Despite tremendous research effort, prevention strategies have failed, and the prevalence of preterm birth in the United States reached 12.3% in 2003.

Prematurity causes 70% of fetal/neonatal deaths. 11.4% of births are at < 37 weeks' gestation. The rate of prematurity increases dramatically with the number of fetuses - singletons 10%; twins 54.9%; and triplets 93.6%

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

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
threatened preterm labor		women presented to the reception unit from 28-37 weeks by regular contractions and opened cervix	Diagnostic Test: three dimensional ultrasound Diagnostic Test: color Doppler

Interventions

Name	Type	Description	Arm Group Labels	Other Names
three dimensional ultrasound	Diagnostic Test	evaluation of the suprarenal glands	threatened preterm labor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the volume of adrenal gland	measurement by three dimensional ultrasound	5 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

singleton fetus less than 37 weeks of gestation
women diagnosed to having Threatened preterm labor.
1. presence of uterine contraction (at least 4 in 20 min or 8 in 60 min )
2. cervical effacement <80 %
3. cervical dilatation <1 cm

Exclusion Criteria:

suspected fetal growth restriction,
maternal medical complications,
presence of fetal heart rate abnormalities at enrollment.
Preterm Premature rupture of membranes
Placenta previa
Lower urinary tract infection or genital infection
Fetal congenital anomaly

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

women with threatened preterm labor

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut Faculty of Medicine		Asyut			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007752	Obstetric Labor, Premature

Ancestor Terms

ID	Term
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided