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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04417296
Other study ID # 004
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2019
Est. completion date August 14, 2021

Study information

Verified date May 2022
Source University of Campania "Luigi Vanvitelli"
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Several types of research examined the relationship of Braxton-Hicks contractions and uterine flow. Nevertheless, no one considered the relationship of the maternal perception of Braxton-Hicks contractions with the fetal wellbeing quantifies through computerised cardiotocography. Our study wants to estimate the correlation between the maternal perception of Braxton-Hicks contractions and antepartum computerised cardiotocography parameters.


Recruitment information / eligibility

Status Completed
Enrollment 49
Est. completion date August 14, 2021
Est. primary completion date April 1, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 48 Years
Eligibility Inclusion Criteria: - Nonlaboring women with a term uncomplicated singleton pregnancy Exclusion Criteria: - complicated singleton pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
antepartum computerised cardiotocography analysis
A common obstetric methodical to evaluate the fetal well-being is the antepartum fetal heart rate (FHR) monitoring through cardiotocography (CTG)

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 comparison of the antepartum computerised cardiotocography between the patients with Braxton-Hicks contractions and the patients without uterine activity 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 pre-intervention