IMPACTS OF BRAXTON-HICKS CONTRACTIONS ON COMPUTERISED CARDIOTOCOGRAPHY PARAMETERS: A POTENTIAL LINK.

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.

Study Overview

• Status: Completed
• Conditions: Braxton Hicks' Contractions
• Intervention / Treatment: Diagnostic test: antepartum computerised cardiotocography analysis

• Study Type: Observational
• Enrollment (Actual): 49

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

We included pregnant who were referred for the fetal antepartum cardiotocography monitoring to the outpatient clinic of the "Luigi Vanvitelli" University of Campania in Naples, Italy. All patients had an uncomplicated pregnancy and to define a pregnancy uncomplicated we adopted Chappell's definition: "a normotensive pregnancy, delivered at >37 weeks, ending in a live-born baby who was not small for gestational age and did not have any other notable pregnancy complications"

Description

Inclusion Criteria:

• Nonlaboring women with a term uncomplicated singleton pregnancy

Exclusion Criteria:

• complicated singleton pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
nonlaboring term singleton pregnancies; All patients had an uncomplicated pregnancy and to define a pregnancy uncomplicated we adopted Chappell's definition: "a normotensive pregnancy, delivered at >37 weeks, ending in a live-born baby who was not small for gestational age and did not have any other notable pregnancy complications"	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Campania "Luigi Vanvitelli"

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2019
• Primary Completion (ACTUAL): April 1, 2020
• Study Completion (ACTUAL): August 14, 2021

Study Registration Dates

• First Submitted: June 1, 2020
• First Submitted That Met QC Criteria: June 1, 2020
• First Posted (ACTUAL): June 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Pregnancy; uterine contractions; Braxton Hicks' contractions; fetal well-being; Computerized cardiotocography (cCTG); Fetal heart rate (FHR)
• Other Study ID Numbers: 004

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