An interventional study of Coconut Oil and Commercial Ultrasound Gel in Pregnancy, High Risk, sponsored by Indiana University. Completed at 1 site in United States. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-02.
Sponsored by Indiana University · Not applicable, Interventional, and Other
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:
Participants will:
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.
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Exclusion Criteria:
After the patient is consented and all questions are answered, the patient's information will be entered into a RedCap and they will be randomized to either starting the scan by first obtaining the required study images with coconut oil and then proceeding to the standard ultrasound using commercial ultrasound gel (Arm 1) or to starting with the scheduled ultrasound using the commercial ultrasound gel and ending by obtaining the required study images using coconut oil (Arm 2). Whether assigned to Arm 1 or Arm 2, prior to the collection of the study images using coconut oil, the participant will be handed a small plastic cup with a pre-measured amount of coconut oil and they will be asked to warm it in their hand for at least 2 minutes. They will then apply the coconut oil to their own abdomen with their hands prior to the ultrasound technician obtaining the required images. The ultrasound technician will collect 3 extra images for study purposes only using the coconut oil.
Device: Coconut Oil · Device: Commercial Ultrasound Gel
After the patient is consented and all questions are answered, the patient's information will be entered into a RedCap and they will be randomized to either starting the scan by first obtaining the required study images with coconut oil and then proceeding to the standard ultrasound using commercial ultrasound gel (Arm 1) or to starting with the scheduled ultrasound using the commercial ultrasound gel and ending by obtaining the required study images using coconut oil (Arm 2). Whether assigned to Arm 1 or Arm 2, prior to the collection of the study images using coconut oil, the participant will be handed a small plastic cup with a pre-measured amount of coconut oil and they will be asked to warm it in their hand for at least 2 minutes. They will then apply the coconut oil to their own abdomen with their hands prior to the ultrasound technician obtaining the required images. The ultrasound technician will collect 3 extra images for study purposes only using the coconut oil.
Device: Coconut Oil · Device: Commercial Ultrasound Gel
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.
Room-temperature Aquasonic 100 (Parker Laboratories, Inc., Fairfield, NJ) applied to patients' abdomen during the ultrasound to serve an another conducting medium.
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.
Time frame: ultrasound scanning, an average of 1 hour
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.
Time frame: after ultrasound scanning, an average of 1 hour
| Milestone | Coconut Oil Followed by Commercial Ultrasound Gel | Commercial Ultrasound Gel Followed by Coconut Oil |
|---|---|---|
| Started | 20 | 20 |
| Completed | 20 | 20 |
| Not completed | 0 | 0 |
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.
| score on a scale | Coconut Oil Quality | Commercial Ultrasound Gel Quality |
|---|---|---|
| BPD/HC | 76.05 ± 3.75 | 76.14 ± 3.75 |
| AC | 75.18 ± 2.50 | 76.35 ± 2.50 |
| FL | 78.00 ± 0.88 | 79.13 ± 0.88 |
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.
| units on a scale | Coconut Oil Followed by Commercial Ultrasound Gel | Commercial Ultrasound Gel Followed by Coconut Oil |
|---|---|---|
| The gel/coconut oil used in the scan was messy. | 4.08 ± 4 | 2.55 ± 2 |
| I experienced itching/burning/redness from the scan. | 4.83 ± 5 | 4.65 ± 5 |
| The gel/coconut oil was easy to remove/rub in after the scan. | 4.50 ± 5 | 3.48 ± 4 |
| I like how my skin felt after using the gel/coconut oil. | 4.55 ± 4 | 2.70 ± 3 |
| I would have a scan with this gel again. | 4.68 ± 4 | 3.78 ± 4 |
Collected over ultrasound scanning, an average of 1 hour. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Coconut Oil | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) |
| Ultrasound Gel | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) |
| Age, Continuous(Years) | Coconut Oil Followed by Commercial Ultrasound Gel | Commercial Ultrasound Gel Followed by Coconut Oil | Total |
|---|
| Sex: Female, Male(Participants) | Coconut Oil Followed by Commercial Ultrasound Gel | Commercial Ultrasound Gel Followed by Coconut Oil | Total |
|---|---|---|---|
| Female | 20 | 20 | 40 |
| Male | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | Coconut Oil Followed by Commercial Ultrasound Gel | Commercial Ultrasound Gel Followed by Coconut Oil | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Coconut Oil Followed by Commercial Ultrasound Gel | Commercial Ultrasound Gel Followed by Coconut Oil | Total |
|---|---|---|---|
| United States | 20 | 20 | 40 |
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