Coconut Oil vs. Commercial Ultrasound Gel In Obstetric Ultrasounds

Pregnancy, High Risk Clinical Trial

Official title:

A Randomized Trial Evaluating Coconut Oil as an Alternative to Commercial Ultrasound Gel in Obstetrical Ultrasounds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05653362
• Other study ID #: 12932
• Status: Completed
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: December 22, 2021

Study information

• Verified date: May 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

After receiving institutional review board approval, we conducted a randomized 2x2 crossover study. Patients could be enrolled in the study 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. 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. After obtaining written consent, study 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, providing: 1) an intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for importing data from external sources.

Patients were randomized to 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. A total of 15g of room-temperature, organic, refined coconut oil was used for each patient. The commercial ultrasound gel used for this study was room-temperature Aquasonic 100 (Parker Laboratories, Inc., Fairfield, NJ) of an unmeasured amount. The patient's abdomen was cleaned off with a towel between applications of each coupling agent. After completion of the ultrasound session, patient satisfaction with both coupling agents was assessed using a ten-question acceptability survey measured on a five-point Likert scale which was adapted from a previously validated survey.

Using a quantifiable scale developed for this study (0-25: unacceptable, 26-50: suboptimal, 51-75: acceptable, and 76-100: optimal), two experienced Maternal-Fetal Medicine physicians rated all study images on quality, resolution, and detail as defined by prior studies2. Quality was defined as an overall assessment of the image encompassing contrast of solid and fluid-filled structures. Resolution was defined as the sharpness and crispness of the image as well as a lack of haziness/blurriness. Detail was defined as the clarity of landmarks and ease with which boundaries of structures are seen and how well they are defined. 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: BPD/HC, AC, and 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 22, 2021
• Est. primary completion date: December 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Singleton pregnancy

• Patients presenting for an anatomy or growth US

• Patients assigned to the pre-determined ultrasound suite that will stay constant throughout the study so that the same ultrasound machine is used to obtain all images.

Exclusion Criteria:

• Allergy to coconut

• Active inflammatory dermatologic conditions (dermatitis, eczema, or psoriasis)

• Multiple gestation pregnancy

Related Conditions & MeSH terms

• Pregnancy, High Risk

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Riley Hospital for Children at IU Health	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

References & Publications (4)

Agero AL, Verallo-Rowell VM. A randomized double-blind controlled trial comparing extra virgin coconut oil with mineral oil as a moisturizer for mild to moderate xerosis. Dermatitis. 2004 Sep;15(3):109-16. doi: 10.2310/6620.2004.04006. — View Citation

DebMandal M, Mandal S. Coconut (Cocos nucifera L.: Arecaceae): in health promotion and disease prevention. Asian Pac J Trop Med. 2011 Mar;4(3):241-7. doi: 10.1016/S1995-7645(11)60078-3. Epub 2011 Apr 12. — View Citation

Esquenazi D, Wigg MD, Miranda MM, Rodrigues HM, Tostes JB, Rozental S, da Silva AJ, Alviano CS. Antimicrobial and antiviral activities of polyphenolics from Cocos nucifera Linn. (Palmae) husk fiber extract. Res Microbiol. 2002 Dec;153(10):647-52. doi: 10.1016/s0923-2508(02)01377-3. — View Citation

Kabara JJ, Swieczkowski DM, Conley AJ, Truant JP. Fatty acids and derivatives as antimicrobial agents. Antimicrob Agents Chemother. 1972 Jul;2(1):23-8. doi: 10.1128/AAC.2.1.23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Ultrasound Images	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.	ultrasound scanning, an average of 1 hour
Secondary	Acceptability	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.	after ultrasound scanning, an average of 1 hour