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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coconut Oil followed by Commercial Ultrasound Gel | Other | 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. |
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| Commercial Ultrasound Gel followed by Coconut Oil | Other | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coconut Oil | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Caroline Rouse, MD | Indiana University Department of Maternal Fetal Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riley Hospital for Children at IU Health | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15724344 | Background | 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. | |
| 21771462 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Coconut Oil Followed by Commercial Ultrasound Gel | This group obtained standard biometry ultrasound images first with coconut oil and then with commercial ultrasound gel. |
| FG001 | Commercial Ultrasound Gel Followed by Coconut Oil | This group obtained standard biometry ultrasound images first with commercial ultrasound gel and then with coconut oil. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Coconut Oil Followed by Commercial Ultrasound Gel | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Data were not collected. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | score on a scale | ultrasound scanning, an average of 1 hour |
|
ultrasound scanning, an average of 1 hour
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Coconut Oil | All participants were exposed to coconut oil at some point during the study. |
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Technicians and patients were not blinded. This study was performed at a single site.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Claire Edelman | Indiana University School of Medicine | 3176509107 | ceedelma@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 3, 2021 | Jan 25, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 26, 2021 | Jan 25, 2023 | ICF_001.pdf |
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|
| Commercial Ultrasound Gel | Device | Room-temperature Aquasonic 100 (Parker Laboratories, Inc., Fairfield, NJ) applied to patients' abdomen during the ultrasound to serve an another conducting medium. |
|
| after ultrasound scanning, an average of 1 hour |
| 4670656 | Background | 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. |
| 12558183 | Background | 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. |
| BG001 | Commercial Ultrasound Gel Followed by Coconut Oil | 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. |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Coconut Oil Quality |
Quality was defined as an overall assessment of the image encompassing contrast of solid and fluid-filled structures. |
| OG001 | Commercial Ultrasound Gel Quality | Quality was defined as an overall assessment of the image encompassing contrast of solid and fluid-filled structures. |
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | after ultrasound scanning, an average of 1 hour |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Ultrasound Gel | All participants were exposed to ultrasound gel at some point during the study. | 0 | 40 | 0 | 40 | 0 | 40 |
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| The gel/coconut oil was easy to remove/rub in after the scan. |
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| I like how my skin felt after using the gel/coconut oil. |
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| I would have a scan with this gel again. |
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