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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04366076
Other study ID # 002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2019
Est. completion date April 20, 2020

Study information

Verified date April 2020
Source University of Campania "Luigi Vanvitelli"
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date April 20, 2020
Est. primary completion date April 20, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 48 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Italy Università degli studi della Campania "Luigi Vanvitelli"- OB & Gyn - Napoli Italia

Sponsors (1)

Lead Sponsor Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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