Does a Relationship Exist Between Fetal Hiccups and Computerised Cardiotocography Parameters?

April 30, 2020 updated by: Marco La Verde, University of Campania "Luigi Vanvitelli"

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Italia
      • Napoli, Italia, Italy, 80138
        • Università degli studi della Campania "Luigi Vanvitelli"- OB & Gyn -

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 48 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • physiological nonlaboring term singleton pregnancies

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary outcome was the correlation between the fetal hiccups and antepartum computerised cardiotocography parameters, in nonlaboring term singleton pregnancies.
Time Frame: pre-intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campania "Luigi Vanvitelli"

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Actual)

April 20, 2020

Study Completion (Actual)

April 20, 2020

Study Registration Dates

First Submitted

April 25, 2020

First Submitted That Met QC Criteria

April 25, 2020

First Posted (Actual)

April 28, 2020

Study Record Updates

Last Update Posted (Actual)

May 4, 2020

Last Update Submitted That Met QC Criteria

April 30, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 002 (University of CT Health Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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