Cervix; Pregnancy Clinical Trial
Official title:
Use of a Pocket-device Point-of-care Ultrasound to Assess Cervical Dilation in Labor: Correlation and Patient Experience
NCT number | NCT05260333 |
Other study ID # | H-50937 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 1, 2022 |
Est. completion date | July 27, 2022 |
Verified date | November 2023 |
Source | Baylor College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary purpose of this study is to compare the accuracy of the Butterfly iQ pocket ultrasound with the digital cervical examination in the third trimester cervix. The secondary aim of this study is to compare discomfort or the two cervical exam methods and determine if patients have a preference for one over the other.
Status | Completed |
Enrollment | 30 |
Est. completion date | July 27, 2022 |
Est. primary completion date | July 27, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Pregnant women in the third trimester presenting for assessment of labor or admitted for labor and delivery. Exclusion Criteria: - Second trimester (less than 28 weeks) - BMI>50 - Does not wish to participate |
Country | Name | City | State |
---|---|---|---|
United States | Texas Children's Hospital Pavilion for Women | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine |
United States,
Mahony BS, Nyberg DA, Luthy DA, Hirsch JH, Hickok DE, Petty CN. Translabial ultrasound of the third-trimester uterine cervix. Correlation with digital examination. J Ultrasound Med. 1990 Dec;9(12):717-23. doi: 10.7863/jum.1990.9.12.717. — View Citation
Newton ER. Chorioamnionitis and intraamniotic infection. Clin Obstet Gynecol. 1993 Dec;36(4):795-808. doi: 10.1097/00003081-199312000-00004. — View Citation
Richey SD, Ramin KD, Roberts SW, Ramin SM, Cox SM, Twickler DM. The correlation between transperineal sonography and digital examination in the evaluation of the third-trimester cervix. Obstet Gynecol. 1995 May;85(5 Pt 1):745-8. doi: 10.1016/0029-7844(95)00027-o. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlation of Cervical Dilation Via Butterfly iQ Pocket Ultrasound in Centimeters | Dilation was measured on the day of the exam in centimeters. A correlation coefficient was then calculated to determine the relationship between the two exams. | 1 day | |
Secondary | Discomfort Scale | 3-point Likert scale (0 = no discomfort, 3 = maximum) discomfort on questionnaire. | 1 day | |
Secondary | Preference for 1 Exam Over the Other | Patients were asked if they had a preference and circled yes or no on questionnaire | 1 day |
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