Adults 18 to 60, female only, with Pregnancy, High Risk. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Quality of Ultrasound ImagesPrimary· ultrasound scanning, an average of 1 hour
The quality of ultrasound images obtained using coconut oil compared with commercial ultrasound gel was assessed using a quantifiable scale developed for this study (0-25: unacceptable, 26-50: suboptimal, 51-75: acceptable, and 76-100: optimal). Using Viewpoint (GE Healthcare), an ultrasound viewing software, the six study images for each patient were presented in the order of coupling agent each patient was randomized to first and second. Each set of three images per coupling agent was in the following order: Biparietal Diameter/Head circumference (BPD/HC), abdominal circumference (AC), and f
BPD/HC
Group
Value
95% CI
Coconut Oil Quality
76.05
± 3.75
Commercial Ultrasound Gel Quality
76.14
± 3.75
AC
Group
Value
95% CI
Coconut Oil Quality
75.18
± 2.50
Commercial Ultrasound Gel Quality
76.35
± 2.50
FL
Group
Value
95% CI
Coconut Oil Quality
78.00
± 0.88
Commercial Ultrasound Gel Quality
79.13
± 0.88
AcceptabilitySecondary· after ultrasound scanning, an average of 1 hour
Patient acceptability of coconut oil as compared to commercial ultrasound gel was assessed using a ten-question acceptability survey measured on a five-point Likert scale which was adapted from a previously validated survey. Higher scores meant a better outcome for questions 1 and 2 and a lower score meant a better outcome for questions 3, 4, and 5. The minimum value was a score of 1 and the maximum value was a score of 5.
The gel/coconut oil used in the scan was messy.
Group
Value
95% CI
Coconut Oil Followed by Commercial Ultrasound Gel
4.08
± 4
Commercial Ultrasound Gel Followed by Coconut Oil
2.55
± 2
I experienced itching/burning/redness from the scan.
Group
Value
95% CI
Coconut Oil Followed by Commercial Ultrasound Gel
4.83
± 5
Commercial Ultrasound Gel Followed by Coconut Oil
4.65
± 5
The gel/coconut oil was easy to remove/rub in after the scan.
Group
Value
95% CI
Coconut Oil Followed by Commercial Ultrasound Gel
4.50
± 5
Commercial Ultrasound Gel Followed by Coconut Oil
3.48
± 4
I like how my skin felt after using the gel/coconut oil.
Group
Value
95% CI
Coconut Oil Followed by Commercial Ultrasound Gel
4.55
± 4
Commercial Ultrasound Gel Followed by Coconut Oil
2.70
± 3
I would have a scan with this gel again.
Group
Value
95% CI
Coconut Oil Followed by Commercial Ultrasound Gel
4.68
± 4
Commercial Ultrasound Gel Followed by Coconut Oil
3.78
± 4
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Indiana University
Last refreshed: 2 June 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05653362.