NCT03757780

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 29, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

November 30, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2019

Completed
Last Updated

January 9, 2019

Status Verified

January 1, 2019

Enrollment Period

2 months

First QC Date

November 27, 2018

Last Update Submit

January 8, 2019

Conditions

Low; Birthweight, Extremely (999 Grams or Less)

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Pregnant ladies who are caffeine using

ladies who uses caffeine during pregnancy

Other: Questionaire

Interventions

QuestionaireOTHER

A questionaire will be made to pregnant ladies who take caffeine during pregnancy

Pregnant ladies who are caffeine using

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Details• pregnant women with age group between : 18-40
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Algazeerah and Kasralainy hospital

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Birth Weight

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mahmoud Alalfy

    Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt

    STUDY CHAIR

Central Study Contacts

Mahmoud Alalfy

CONTACT

01002611058mahmoudalalfy@ymail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2018

First Posted

November 29, 2018

Study Start

November 30, 2018

Primary Completion

February 1, 2019

Study Completion

February 15, 2019

Last Updated

January 9, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)