Low Birth Weight Fetuses With Caffeine Use

January 8, 2019 updated by: Aljazeera Hospital

Association of Low Birth Weight Fetuses With Caffeine Use

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt
        • Recruiting
        • Algazeerah and Kasralainy hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Age group: 18-40

•Pregnant females attending regular post-natal care visits

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pregnant ladies who are caffeine using
ladies who uses caffeine during pregnancy
Other: Questionaire
A questionaire will be made to pregnant ladies who take caffeine during pregnancy

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aljazeera Hospital

Collaborators

Kasr El Aini Hospital

Investigators

  • Study Chair: Mahmoud Alalfy, Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2018

Primary Completion (Anticipated)

February 1, 2019

Study Completion (Anticipated)

February 15, 2019

Study Registration Dates

First Submitted

November 27, 2018

First Submitted That Met QC Criteria

November 27, 2018

First Posted (Actual)

November 29, 2018

Study Record Updates

Last Update Posted (Actual)

January 9, 2019

Last Update Submitted That Met QC Criteria

January 8, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • low birth weight

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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