NCT04397874

Brief Summary

Several studies analysed the association of fetal movement counting with perinatal mortality and fetal outcomes. However, no one examined the relationship of the maternal perception of fetal movement with the fetal wellbeing quantifies through computerised cardiotocography. Our study evaluates the correlation between the maternal perception of fetal movement and antepartum computerised cardiotocography parameters.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

April 1, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 21, 2020

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

5.7 years

First QC Date

May 18, 2020

Last Update Submit

March 10, 2024

Conditions

Fetal Movement

Keywords

Fetal movementFetal activityfetal assessmentfetal well-beingComputerized cardiotocography (cCTG)Fetal heart rate (FHR)

Outcome Measures

Primary Outcomes (1)

  • To estimate the correlation between the maternal perception of fetal movement and antepartum computerised cardiotocography parameters.

    External cCTG was completed at least 20 minutes (maximum 60 minutes), two transducers were placed on the maternal abdomen: one over the fetal heart level and the other one at the uterine fundus. For each cCTG, the following data were evaluated: Basal FHR

Interventions

; Computerized cardiotocography (cCTG)DIAGNOSTIC_TEST

To estimate the correlation between the maternal perception of fetal movement and antepartum computerised cardiotocography parameters.

Eligibility Criteria

Age18 Years - 48 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

physiological nonlaboring term singleton pregnancies

You may qualify if:

  • nonlaboring term singleton pregnancies (37 0/7 - 41 6/7 weeks of gestation)

You may not qualify if:

  • fetal malformations, stillbirths, preterm deliveries

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

RECRUITING

Central Study Contacts

Marco La Verde, MD

CONTACT

+393389412266dr.marcolaverde@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, research , gynecology and obstetrics, Principal Investigator

Study Record Dates

First Submitted

May 18, 2020

First Posted

May 21, 2020

Study Start

April 1, 2019

Primary Completion

December 1, 2024

Study Completion

September 1, 2025

Last Updated

March 12, 2024

Record last verified: 2024-03

Locations

IT(1)