NCT04366076

Brief Summary

BACKGROUND: The physiological function of fetal hiccups and its correlation with fetal well-being is unexplored. No previous study examines the correlation between the maternal perception of the fetal hiccups and the antepartum cardiotocography. OBJECTIVE: To evaluate the correlation between the fetal hiccups and antepartum computerised cardiotocography parameters, in nonlaboring term singleton pregnancies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2019

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

April 1, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 28, 2020

Completed
Last Updated

May 4, 2020

Status Verified

April 1, 2020

Enrollment Period

1.1 years

First QC Date

April 25, 2020

Last Update Submit

April 30, 2020

Conditions

Keywords

Fetal hiccupsfetal movementcomputerised cardiotocographycardiotocographycomputerized analysis

Outcome Measures

Primary Outcomes (1)

  • The primary outcome was the correlation between the fetal hiccups and antepartum computerised cardiotocography parameters, in nonlaboring term singleton pregnancies.

    antepartum computerised cardiotocography parameters are the baseline fetal heart rate (Basal FHR), accelerations and decelerations, long-term FHR variation (LTV), short-term FHR variation (STV), episodes of high/low FHR variation and number of fetal movements for an hour (FM)

    pre-intervention

Study Arms (1)

nonlaboring term singleton pregnancies

A total of 51 nonlaboring term singleton pregnancies were enrolled.

Diagnostic Test: Fetal heart rate (FHR) monitoring through computerized cardiotocography (cCTG) analysis antepartum

Interventions

The investigator conducted antepartum surveillance through computerized cardiotocography (cCTG) analysis antepartum. This is a non-invasive method to study fetal well being. For each patient, a cCTG was attended using a computerized cardiotocography machine. External cCTG was practised for no less than 20 min (max 60 min), two transducers were fixed on the maternal abdomen: one above the fetal heart level and the other at the uterine fundus

nonlaboring term singleton pregnancies

Eligibility Criteria

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

physiological nonlaboring term singleton pregnancies (\>37 weeks) without maternal or fetal complication

You may qualify if:

  • physiological nonlaboring term singleton pregnancies

You may not qualify if:

  • Gestations complicated by fetal malformations, stillbirth, preterm deliveries or patients with missing data were excluded.

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

MeSH Terms

Interventions

Heart Rate, Fetal

Intervention Hierarchy (Ancestors)

Heart RateHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

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

April 25, 2020

First Posted

April 28, 2020

Study Start

April 1, 2019

Primary Completion

April 20, 2020

Study Completion

April 20, 2020

Last Updated

May 4, 2020

Record last verified: 2020-04

Locations