Low Birth Weight Fetuses With Caffeine Use | NCT03757780

Studies
Low Birth Weight Fetuses With Caffeine Use

NCT03757780

Sponsor

Aljazeera Hospital

Status

Unknown status

Last Update Posted

Jan 9, 2019Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Low; Birthweight, Extremely (999 Grams or Less)

Interventions

Questionaire

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

Jan 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 30, 2018Actual

Primary Completion Date

Feb 1, 2019Estimated

Completion Date

Feb 15, 2019Estimated

First Submitted Date

Nov 27, 2018

First Submission Date that Met QC Criteria

Nov 27, 2018

First Posted Date

Nov 29, 2018Actual

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

Jan 8, 2019

Last Update Posted Date

Jan 9, 2019Actual

Name	Class
Kasr El Aini Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Globally, it has been estimated that 15.5% of all infantsare born low birth weight, defined as birthweight less than 2,500 g .

Detailed Description

Low birth weight is not only associated with neonatal mortality and morbidity.

but also with a higher risk of chronic diseases such as type 2 diabetes and cardiovascular diseases in adult life

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

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pregnant ladies who are caffeine using		ladies who uses caffeine during pregnancy	Other: Questionaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionaire	Other	A questionaire will be made to pregnant ladies who take caffeine during pregnancy	Pregnant ladies who are caffeine using

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of pregnant ladies who will have low birth weight babies	Mothers who will give birth to low birth weight infants	within 2 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age group: 18-40
Pregnant females attending regular post-natal care visits

Exclusion Criteria:

• Female patients with other acute or chronic illness
- Cardiovascular disease
- Neoplasms
- Current diabetes mellitus, pregnancy induced diabetes
- Renal impairment (serum creatinine 120 mol/liter), and hypertension (blood pressure 140/85 mm Hg).

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

• pregnant women with age group between : 18-40

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Age group: 18-40

•Pregnant females attending regular post-natal care visits

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mahmoud Alalfy	Contact	01002611058		mahmoudalalfy@ymail.com

Overall Officials

Name	Affiliation	Role
Mahmoud Alalfy	Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Algazeerah and Kasralainy hospital	Recruiting	Giza			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

Condition Browse Module

MeSH Terms

ID	Term
D001724	Birth Weight

Ancestor Terms

ID	Term
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided