Computerized Cardiotocography and Maternal Coffee Habits

October 3, 2022 updated by: Marco La Verde, University of Campania "Luigi Vanvitelli"

Computerized Cardiotocography and Fetal Heart Response to Maternal Coffee Intake: A Prospective Study

The study includes pregnant women referred for foetal antepartum computerized cardiotocography (cCTG) monitoring as outpatients. Pregnant women were divided into two groups based on their coffee intake: the coffee group and the control group. Each pregnant woman had cCTG. Two doctors assessed and recorded the amount of coffee taken by pregnant women before the CTG.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

134

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

  • Italy
    • Italia
      • Napoli, Italia, Italy, 80138
        • Università degli studi della Campania "Luigi Vanvitelli"- OB & Gyn -

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 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

we included only term pregnant, who performed a computerized cardiotocography before the delivery.

Description

Inclusion Criteria:

  • gestationale age >37 weeks

Exclusion Criteria:

  • fetal malformations,
  • stillbirths
  • preterm labour
  • preterm and term premature rupture of membranes

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Coffe group
Pregnant women who referred caffeine intake.
Control group
Pregnant women without caffeine intake.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Computerized cardiotocography
Time Frame: 1 day (cardiotocographic's test)
Computerized cardiotocography (cCTG) parameters evaluate the fetal heart rate. We analyzed the cCTG between the two groups: pregnant who took coffee and pregnant with no coffee intake.
1 day (cardiotocographic's test)

Collaborators and Investigators

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

Sponsor

University of Campania "Luigi Vanvitelli"

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)

July 1, 2022

Primary Completion (Actual)

August 30, 2022

Study Completion (Actual)

September 28, 2022

Study Registration Dates

First Submitted

September 28, 2022

First Submitted That Met QC Criteria

October 3, 2022

First Posted (Actual)

October 4, 2022

Study Record Updates

Last Update Posted (Actual)

October 4, 2022

Last Update Submitted That Met QC Criteria

October 3, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0018443/i

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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