Trial Outcomes & Findings for Coconut Oil vs. Commercial Ultrasound Gel In Obstetric Ultrasounds (NCT NCT05653362)

Results Overview

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 femur length (FL). The physicians rating the images were blinded to the agent used to capture each image and had no knowledge of the randomization list created by the study statisticians. The image quality scores given by the two experienced Maternal-Fetal Medicine physicians were averaged to compute a single score for each image per coupling agent.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

ultrasound scanning, an average of 1 hour

Results posted on

2023-06-02

Participant Flow

Participant milestones

Participant milestones
Measure	Coconut Oil Followed by Commercial Ultrasound Gel This group obtained standard biometry ultrasound images first with coconut oil and then with commercial ultrasound gel.	Commercial Ultrasound Gel Followed by Coconut Oil This group obtained standard biometry ultrasound images first with commercial ultrasound gel and then with coconut oil.
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data were not collected.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Coconut Oil Followed by Commercial Ultrasound Gel n=20 Participants Patients could be enrolled if they had a singleton pregnancy and were presenting for a routine growth or anatomy ultrasound. Exclusion criteria included an allergy to coconut, active inflammatory dermatologic conditions, and a multiple gestation pregnancy. After obtaining written consent from study participants, data were collected and managed using REDCap electronic data capture tools. REDCap (Research Electronic Data Capture) is a secure, web-based application designed to support data capture for research studies. A single ultrasound machine (GE Voluson E10) was used to obtain all images during this study. The three standard fetal biometry views - biparietal diameter (BPD)/head circumference (HC), abdominal circumference (AC), and femur length (FL) - were obtained by qualified ultrasound technicians for each patient with both coupling agents, for a total of six study images per patient. Patients were randomized to the sequence in which they would receive the coupling agents (i.e., either starting their scheduled ultrasound exam by obtaining the three study images using coconut oil and then proceeding with the standard ultrasound using commercial ultrasound gel or vice versa). Ultimately, forty patients were randomized into two even groups. Neither patients nor ultrasound technicians were blinded from sequence assignment, but physicians rating the images were blinded to assignment.	Commercial Ultrasound Gel Followed by Coconut Oil n=20 Participants Patients could be enrolled if they had a singleton pregnancy and were presenting for a routine growth or anatomy ultrasound. Exclusion criteria included an allergy to coconut, active inflammatory dermatologic conditions, and a multiple gestation pregnancy. After obtaining written consent from study participants, data were collected and managed using REDCap electronic data capture tools. REDCap (Research Electronic Data Capture) is a secure, web-based application designed to support data capture for research studies. A single ultrasound machine (GE Voluson E10) was used to obtain all images during this study. The three standard fetal biometry views - biparietal diameter (BPD)/head circumference (HC), abdominal circumference (AC), and femur length (FL) - were obtained by qualified ultrasound technicians for each patient with both coupling agents, for a total of six study images per patient. Patients were randomized to the sequence in which they would receive the coupling agents (i.e., either starting their scheduled ultrasound exam by obtaining the three study images using coconut oil and then proceeding with the standard ultrasound using commercial ultrasound gel or vice versa). Ultimately, forty patients were randomized into two even groups. Neither patients nor ultrasound technicians were blinded from sequence assignment, but physicians rating the images were blinded to assignment.	Total n=40 Participants Total of all reporting groups
Sex: Female, Male Female	20 Participants n=20 Participants	20 Participants n=20 Participants	40 Participants n=40 Participants
Sex: Female, Male Male	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	20 participants n=20 Participants	20 participants n=20 Participants	40 participants n=40 Participants

PRIMARY outcome

Timeframe: 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 femur length (FL). The physicians rating the images were blinded to the agent used to capture each image and had no knowledge of the randomization list created by the study statisticians. The image quality scores given by the two experienced Maternal-Fetal Medicine physicians were averaged to compute a single score for each image per coupling agent.

Outcome measures

Outcome measures
Measure	Coconut Oil Quality n=40 Participants Quality was defined as an overall assessment of the image encompassing contrast of solid and fluid-filled structures.	Commercial Ultrasound Gel Quality n=40 Participants Quality was defined as an overall assessment of the image encompassing contrast of solid and fluid-filled structures.
Quality of Ultrasound Images BPD/HC	76.05 score on a scale Standard Error 3.75	76.14 score on a scale Standard Error 3.75
Quality of Ultrasound Images AC	75.18 score on a scale Standard Error 2.50	76.35 score on a scale Standard Error 2.50
Quality of Ultrasound Images FL	78.00 score on a scale Standard Error 0.88	79.13 score on a scale Standard Error 0.88

SECONDARY outcome

Timeframe: after ultrasound scanning, an average of 1 hour

Population: The arms/groups are combined because each participant had images obtained with both coconut oil and standard ultrasound gel during their ultrasound. It was only the order of application that was randomized so as not to bias the acceptability survey. Data was collected after every participant had all images obtained (4 with coconut oil and 4 with standard gel), not separately after each application.

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.

Outcome measures

Outcome measures
Measure	Coconut Oil Quality n=20 Participants Quality was defined as an overall assessment of the image encompassing contrast of solid and fluid-filled structures.	Commercial Ultrasound Gel Quality n=20 Participants Quality was defined as an overall assessment of the image encompassing contrast of solid and fluid-filled structures.
Acceptability The gel/coconut oil used in the scan was messy.	4.08 units on a scale Standard Deviation 4	2.55 units on a scale Standard Deviation 2
Acceptability I experienced itching/burning/redness from the scan.	4.83 units on a scale Standard Deviation 5	4.65 units on a scale Standard Deviation 5
Acceptability The gel/coconut oil was easy to remove/rub in after the scan.	4.50 units on a scale Standard Deviation 5	3.48 units on a scale Standard Deviation 4
Acceptability I like how my skin felt after using the gel/coconut oil.	4.55 units on a scale Standard Deviation 4	2.70 units on a scale Standard Deviation 3
Acceptability I would have a scan with this gel again.	4.68 units on a scale Standard Deviation 4	3.78 units on a scale Standard Deviation 4

Adverse Events

Coconut Oil

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ultrasound Gel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Claire Edelman

Indiana University School of Medicine

Phone: 3176509107

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place