Computerized Cardiotocography and Maternal Coffee Habits | NCT05564910

Studies
Computerized Cardiotocography and Maternal Coffee Habits

NCT05564910

Sponsor

University of Campania Luigi Vanvitelli

Status

Completed

Last Update Posted

Oct 4, 2022Actual

Enrollment

134Actual

Phase

Not provided

Conditions

Prenatal Care

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2022Actual

Primary Completion Date

Aug 30, 2022Actual

Completion Date

Sep 28, 2022Actual

First Submitted Date

Sep 28, 2022

First Submission Date that Met QC Criteria

Oct 3, 2022

First Posted Date

Oct 4, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 3, 2022

Last Update Posted Date

Oct 4, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marco La Verde, Researcher, University of Campania Luigi VanvitelliPrincipal Investigator

Lead Sponsor

University of Campania Luigi VanvitelliOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

134Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Coffe group		Pregnant women who referred caffeine intake.
Control group		Pregnant women without caffeine intake.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

gestationale age >37 weeks

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

pregnant women

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Università degli studi della Campania "Luigi Vanvitelli"- OB & Gyn -		Naples	Italia	80138	Italy