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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05564910
Other study ID # 0018443/i
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2022
Est. completion date September 28, 2022

Study information

Verified date October 2022
Source University of Campania "Luigi Vanvitelli"
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 134
Est. completion date September 28, 2022
Est. primary completion date August 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - gestationale age >37 weeks Exclusion Criteria: - fetal malformations, - stillbirths - preterm labour - preterm and term premature rupture of membranes

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Italy Università degli studi della Campania "Luigi Vanvitelli"- OB & Gyn - Napoli Italia

Sponsors (1)

Lead Sponsor Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Computerized cardiotocography 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)
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