Coconut Oil vs. Commercial Ultrasound Gel In Obstetric Ultrasounds

NCT05653362 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-06-02

Study results available
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Summary

The goal of this randomized controlled trial is to compare the use of coconut oil with commercial ultrasound gel for obstetrical ultrasounds. The main questions it aims to answer are:

1. To evaluate the quality of ultrasound images obtained using coconut oil compared with commercial ultrasound gel.
2. To access patient acceptability of coconut oil as compared to commercial ultrasound gel.

Participants will:

1. Allow a total of 6 study images to be obtained; 3 using coconut oil and 3 with commercial ultrasound gel.
2. Fill out a 10-question, 5-point Likert scale survey following their ultrasound with both coupling mediums to compare acceptability.

Conditions

  • Pregnancy, High Risk

Interventions

DEVICE

Coconut Oil

Coconut oil was applied to the patients' abdomen during the ultrasound to serve as a conducting medium. When applied topically, coconut oil is not absorbed systemically by the subject and will not affect the fetus. There are no studies showing a potential risk of the use of topical coconut oil in pregnancy. Subjects with a coconut allergy will be excluded from this study due to risk of allergic reaction.

DEVICE

Commercial Ultrasound Gel

Room-temperature Aquasonic 100 (Parker Laboratories, Inc., Fairfield, NJ) applied to patients' abdomen during the ultrasound to serve an another conducting medium.

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • Caroline Rouse, MD · Indiana University Department of Maternal Fetal Medicine

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2021-12-22
Completion
2021-12-22
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05653362 on ClinicalTrials.gov