NCT05564910

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
134

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 4, 2022

Completed
Last Updated

October 4, 2022

Status Verified

October 1, 2022

Enrollment Period

2 months

First QC Date

September 28, 2022

Last Update Submit

October 3, 2022

Conditions

Prenatal Care

Keywords

computerised cardiotocographyFetal monitoringnutrition in pregnancyprenatal carefetal heart rate

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (2)

Coffe group

Pregnant women who referred caffeine intake.

Control group

Pregnant women without caffeine intake.

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • gestationale age \>37 weeks

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Università degli studi della Campania "Luigi Vanvitelli"- OB & Gyn -

Napoli, Italia, 80138, Italy

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

September 28, 2022

First Posted

October 4, 2022

Study Start

July 1, 2022

Primary Completion

August 30, 2022

Study Completion

September 28, 2022

Last Updated

October 4, 2022

Record last verified: 2022-10

Locations

IT(1)