Pregnancy, High Risk
Conditions
Keywords
ultrasonography, coconut oil, ultrasound gel
Brief 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.
Detailed 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.
Interventions
DEVICECoconut 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.
DEVICECommercial Ultrasound Gel
Room-temperature Aquasonic 100 (Parker Laboratories, Inc., Fairfield, NJ) applied to patients' abdomen during the ultrasound to serve an another conducting medium.
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Ultrasound Images | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | — | Total | Coconut Oil Followed by Commercial Ultrasound Gel | Commercial Ultrasound Gel Followed by Coconut Oil |
|---|---|---|---|---|
| Age, Continuous | — Years | — | — | — |
| Race and Ethnicity Not Collected | — | 0 Participants | — | — |
| Region of Enrollment United States | — | 40 participants | 20 participants | 20 participants |
| Sex: Female, Male Female | — | 40 Participants | 20 Participants | 20 Participants |
| Sex: Female, Male Male | — | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
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.
Time frame: ultrasound scanning, an average of 1 hour
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Coconut Oil Quality | Quality of Ultrasound Images | BPD/HC | 76.05 score on a scale | Standard Error 3.75 |
| Coconut Oil Quality | Quality of Ultrasound Images | AC | 75.18 score on a scale | Standard Error 2.5 |
| Coconut Oil Quality | Quality of Ultrasound Images | FL | 78.00 score on a scale | Standard Error 0.88 |
| Commercial Ultrasound Gel Quality | Quality of Ultrasound Images | BPD/HC | 76.14 score on a scale | Standard Error 3.75 |
| Commercial Ultrasound Gel Quality | Quality of Ultrasound Images | AC | 76.35 score on a scale | Standard Error 2.5 |
| Commercial Ultrasound Gel Quality | Quality of Ultrasound Images | FL | 79.13 score on a scale | Standard Error 0.88 |
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Coconut Oil Quality | Acceptability | I experienced itching/burning/redness from the scan. | 4.83 units on a scale | Standard Deviation 5 |
| Coconut Oil Quality | Acceptability | I like how my skin felt after using the gel/coconut oil. | 4.55 units on a scale | Standard Deviation 4 |
| Coconut Oil Quality | Acceptability | The gel/coconut oil was easy to remove/rub in after the scan. | 4.50 units on a scale | Standard Deviation 5 |
| Coconut Oil Quality | Acceptability | I would have a scan with this gel again. | 4.68 units on a scale | Standard Deviation 4 |
| Coconut Oil Quality | Acceptability | The gel/coconut oil used in the scan was messy. | 4.08 units on a scale | Standard Deviation 4 |
| Commercial Ultrasound Gel Quality | Acceptability | I would have a scan with this gel again. | 3.78 units on a scale | Standard Deviation 4 |
| Commercial Ultrasound Gel Quality | Acceptability | The gel/coconut oil used in the scan was messy. | 2.55 units on a scale | Standard Deviation 2 |
| Commercial Ultrasound Gel Quality | Acceptability | I experienced itching/burning/redness from the scan. | 4.65 units on a scale | Standard Deviation 5 |
| Commercial Ultrasound Gel Quality | Acceptability | The gel/coconut oil was easy to remove/rub in after the scan. | 3.48 units on a scale | Standard Deviation 4 |
| Commercial Ultrasound Gel Quality | Acceptability | I like how my skin felt after using the gel/coconut oil. | 2.70 units on a scale | Standard Deviation 3 |