A Randomized Trial Evaluating Coconut Oil as an Alternative to Commercial Ultrasound Gel in Obstetrical Ultrasounds
Phase: NA
Conditions: Pregnancy, High Risk
Sponsor: Indiana University

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A Randomized Trial Comparing Coconut Oil as a Low-Cost 
Alternative to Commercial Ultrasound Gel 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table of Contents: 
Study Schema 
1.0 
Background & Rationale 
2.0 
Objective(s) 
2.1 
Primary Objective 
2.2 
Secondary Objective 
3.0 
Outcome Measures 
3.1 
Primary Outcome Measures 
3.2 
Secondary Outcome Measures 
4.0 
Eligibility Criteria 
4.1 
Inclusion Criteria 
4.2 
Exclusion Criteria 
5.0 
Study Design 
6.0 
Enrollment/Randomization 
7.0 
Study Procedures 
8.0 
Reportable Events 
9.0 
Data Safety Monitoring 
10.0 
Study Withdrawal/Discontinuation 
11.0 
Statistical Considerations 
12.0 
Data Management 
13.0 
Privacy/Confidentiality Issues 
14.0 
References 
15.0 
Appendix 1 – Patient Acceptability Survey 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1.0 Background and Rationale 
 
Ultrasound is a fundamental diagnostic tool in Obstetrics in both resource-rich and resource-
limited settings. One barrier to sustainable ultrasound use in low-resource settings is access to 
the necessary consumable goods, specifically ultrasound gel, to serve as the coupling medium 
required to conduct the sound waves between the ultrasound probe and the patient’s tissue to 
produce quality images.  In low-resource settings, unreliable access to commercial ultrasound gel 
and its high cost can limit routine use of ultrasonography.  
 
Coconut oil is a low cost and widely available alternative to commercial ultrasound gel that 
additionally has been shown to be moisturizing, antibacterial, anti-inflammatory, and safe. There 
are no studies to date that compare the quality of ultrasound images obtained using coconut oil 
and commercial ultrasound gel. There are also no studies that evaluate patient satisfaction with 
the use of coconut oil as a coupling medium for OB ultrasounds.  
 
Coconut oil is isolated from the kernel or meat of mature coconuts harvested from the coconut 
palm (Cocos nucifera). It has been shown to be as effective as mineral oil as a moisturizer to 
treat mild to moderate xerosis [1], however, it has the additional benefit of being antiseptic. 
Coconut oil is made up of medium-chain fatty acids which are effective in destroying lipid-
coated bacteria [2]. Studies have shown that lauric acid is the most inhibitory saturated fatty acid 
against gram-positive organisms such as the streptococcus and staphylococcus species that are 
the most common causes of bacterial skin infections. Coconut oil happens to be the highest 
natural source of lauric acid, making up almost 50% of coconut’s fat content [3]. Cellular studies 
have also shown that monoglyceride derivatives of lauric acid exhibit antiviral and antifungal 
activity [4]. Additionally, coconut oil increases the expression of skin barrier molecules and 
collagen, enhancing skin’s barrier function and improving hydration by preventing water 
evaporation [5]. The annual average cost of coconut oil in 2020 per the World Bank 
Commodities Price Data was 1,010 USD/mt which can be converted to 0.0010 USD/g or 0.02 
USD/20g [6]. At Indiana University Hospitals, the standard ultrasound gel used, Aquasonic 100 
(Parker Laboratories, Inc., Fairfield, NJ), is sold in 20g packets for 0.34 USD. Therefore, the 
standard ultrasound gel used at Indiana University Hospitals is 17 times more expensive than 
coconut oil by weight. Of the world’s 195 countries, 95 produce coconuts, with the Philippines, 
Indonesia, and India producing about 70% of the world’s total copra, the dried coconut kernel 
from which coconut oil is made [7]. Coconut oil is a readily accessible resource in these 
countries and most countries worldwide.  
 
We plan to perform a blinded equivalence study to formally evaluate coconut oil as an 
alternative to commercially produced ultrasound gel by comparing the quality of ultrasound 
images using each respective coupling media. Additionally, we aimed to assess patients’ 
satisfaction with the use of coconut oil for this purpose. This study will use organic refined 
coconut oil.  
 
 
 
 
 

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2.0 Objectives 
 
2.1 Primary Objective 
• To evaluate the quality of ultrasound images obtained using coconut oil 
compared with commercial ultrasound gel. 
2.2 Secondary Objective 
• To access patient acceptability of coconut oil as compared to commercial 
ultrasound gel.  
 
3.0 Outcome Measures/Endpoints 
 
3.1 Image Quality 
• Paired images will be displayed side by side in random order and each of the 
following parameters will be assessed using a 10 cm visual analog scale by a 
blinded reader: 
o Resolution – sharpness/crispness of image, lack of haziness 
o Image detail – clarity of organ outlines and ease with which boundaries of 
structures are seen  
o Total image quality – contrast of solid and fluid-filled structures and 
absence of noise  
o Clarity/definition: 
▪ BPD/HC – thalami and CSP 
▪ Abdominal circumference – umbilical vein, portal sinus 
▪ FL - femur bow definition  
 
3.2 Patient Acceptability  
• A 10-question, 5-point Likert scale survey will be administered to all 
participants following their ultrasound with both coupling mediums to 
compare acceptability.  
• See Appendix 1 for patient survey.  
 
 
4.0 Eligibility Criteria 
 
4.1 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.  
 
4.2 Exclusion Criteria 
• Allergy to coconut 
• Active inflammatory dermatologic conditions (dermatitis, eczema, or 
psoriasis)  
• Multiple gestation pregnancy 

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5.0 Study Design 
 
 
 
 
6.0 Enrollment/Randomization  
6.1 Patients assigned to have their anatomy or growth ultrasound at the Maternal Fetal 
Medicine clinic in the Riley Outpatient Center will be approached to participate after 
the patient is roomed in the ultrasound suite and while they are waiting for the 
ultrasound technician to begin the scan.  
6.2 The patient will be randomized to either starting the exam by first obtaining the study 
images with coconut oil and then proceeding with the standard ultrasound using 
commercial ultrasound gel or starting with the scheduled ultrasound using the 
commercial ultrasound gel and ending by obtaining the study images using coconut 
oil.  
6.3 The same ultrasound machine will be used to obtain all images in this study. This 
means that only patients assigned to have their imaging in the ultrasound suite with 
the “study ultrasound machine” will be included in the study.  
 
 
7.0 Study Procedures 
 
7.1 Recruitment and consent will take place in the ultrasound suite after the patient’s 
vitals are collected and while they are waiting for the ultrasound technician to begin 
the ultrasound scan.  
7.2 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).  
Randomize
1:1
Total 40: Obtain informed consent. Screen potential particpants by 
inclusion and exclusion criteria. 
Arm 1: Coconut Oil First
N=20
Arm 2: Commercial 
Ultrasound Gel First 
N=20

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7.3 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.  
7.4 The ultrasound technician will collect 3 extra images for study purposes only using 
the coconut oil. This will only require 5-10 extra minutes of your time.  
7.5 The ultrasound technician will drag the 3 fetal biometry images obtained with 
coconut oil and the 3 fetal biometry images obtained with commercial gel to the 
bottom of the set of images obtained throughout the study. They will label the images 
according to their randomization. For example, if randomized to coconut oil first 
followed by commercial gel, the coconut oil images with be labeled 1 and the 
commercial gel images labeled as 2. The images will be paired next to their 
counterpart.  
7.6 While the images are being labeled and sorted, the patient will quickly fill out the 
short Patient Acceptability Survey.  
7.7 The patient will be thanked for their participation and continue with the scheduled 
visit. A towel will be provided to clean off ultrasound gel or coconut oil as needed.  
 
8.0 Reportable Events 
 
8.1 Any adverse events or unanticipated problems involving risk to participants will be 
reported to the Indiana University Human Research Protection Program (HRPP) at 
(317) 274-8289 or via email at irb@iu.edu. 
8.2 An adverse event (AE) for this study would be a side effect caused by the coconut oil 
used in the study. A serious adverse event (SAE) would be an anaphylactic reaction 
to the coconut oil used in the study. Collection of AEs and SAEs will begin at the 
start of interventions.  
 
9.0 Data Safety Monitoring 
 
9.1 Images obtained for the study will be saved in the standard way, using the Viewoint 
software. 
9.2 Patient information will be entered into a secure RedCap: Name, MRN, BMI 
9.3 Patient acceptability surveys will be entered directly into RedCap using an Ipad and 
dual-factor authentication. 
 
10.0 
Study Withdrawal/Discontinuation 
 
10.1 
At any time during the study, the participant can decide to withdraw themself 
from the study at which point they will receive the ultrasound for which they were 
scheduled without the use of coconut oil as the ultrasound coupling media. 
Withdrawing from the study will not alter the care the patient receives.  
 
 
 

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11.0 
Statistical Consideration  
 
Study Design 
 
There are 3 views for a given ultrasound, 2 raters will rate each image on 4 different 
factors, and each person will receive ultrasound using both types of medium (Coconut 
oil vs Commercial gel).  Only image raters will be blinded to the medium used.  Pateints 
will be provided the two mediums in a different order (although the specific images will 
be in the same order).  Quality will be estimated by two raters.  Patient satisfaction with 
both mediums will be asked at the end of the ultrasound session and will ask patients 
how satisfied they were with each specific medium (Coconut oil vs Commercial gel) 
since they aren’t blinded to type. 
 
The study statistician will create a randomization list (A vs B) as to which medium each 
woman will receive first. 
 
4 factors: Quality (Equivalence outcome), Resolution, Detail, Specific anatomic view 
(Based on a given image).  All factors other than quality will be analyzed with a 
standard superiority hypothesis. 
 
The primary hypothesis is that image quality (overall) will be equivalent between the 
two types of ultrasound medium.  This will be tested using the within-patient contrast 
obtained from a linear mixed model.   
 
Report Definitions 
N is the number of items sampled from the population.  Effect Size: d = (μ1 - 
μ1) / σ is the effect size. Cohen recommended Low = 0.2, Medium = 0.5, and 
High = 0.8.  σ is the assumed population standard deviation of the paired 
differences.  Alpha is the probability of rejecting a true null hypothesis. 
 
Our primary hypothesis for equivalence: 
0
1
:
10 or 
10  vs. 
: 10
10
H
H



−

−

  
With N = 40, an equivalence test of the mean difference in image quality 
(measured on 0 to 100 scale) from a paired design using two one-sided t-tests 
(which should provide similar power to the contrast from our model), 
achieves 83% power at .05 significance level when the actual paired 
difference is 5 and the estimated standard deviation of paired differences is 
12 when equivalence limits are -10 and 10.  For the continuous outcome of 
patient satisfaction, we will have 80% power to detect an ES = 0.45 with 
type I error set at .05 based on a paired t-test which provides similar power 
to the contrast from our model. 
 
Statistical analysis 

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Descriptive statistics of image outcomes of quality, resolution, and detail 
will be summarized overall and separately by medium.  For the specific 
anatomic view, this will be estimated separately for each view by medium. 
For the primary outcome, a linear mixed model will be fit to quality, 
including effects for view and medium (Coconut oil vs Commercial gel and 
a random rater effect.  To test the hypothesis, the within-person mean 
difference in image quality for Commercial gel vs Coconut oil will be 
estimated along with associated 90% confidence interval.  If the confidence 
interval is inside the equivalence region of [-10, 10], we will reject the null 
hypothesis and conclude Coconut oil is equivalent to Commercial gel with 
regard to quality. 
 
For all other image outcomes, a similar model will be fit except the mean 
difference in the outcome between mediums and associated 95% confidence 
interval will be reported as we do not a priori know which medium will be 
better.  Therefore, we report standard superiority hypothesis with type I error 
set at 0.05.  For the outcome of the specific anatomic view, the model will 
only be fit for that specific image, thus the model will not contain the effect 
of view. All models will be examined for fit. 
 
12.0 
Statistical Data Management  
 
12.1 
All data will be collected and entered directly into RedCap and protected with 
dual-factor authentication.  
 
13.0 
Privacy/Confidentiality Issues 
 
13.1 
Recruitment, consent, and study interventions will take place in a private 
ultrasound suite.  
13.2 
All study information and data will be securely kept in a RedCap database. 
 
14.0 
References 
 
1) 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;15(3):109-116. doi:10.2310/6620.2004.04006 
2) DebMandal M, Mandal S. Coconut (Cocos nucifera L.: Arecaceae): in health promotion and 
disease prevention. Asian Pac J Trop Med. 2011;4(3):241-247. doi:10.1016/S1995-
7645(11)60078-3 
3) Kabara JJ, Swieczkowski DM, Conley AJ, Truant JP. Fatty acids and derivatives as 
antimicrobial agents. Antimicrob Agents Chemother. 1972;2(1):23-28. 
doi:10.1128/AAC.2.1.23 
4) Esquenazi D, Wigg MD, Miranda MM, et al. Antimicrobial and antiviral activities of 
polyphenolics from Cocos nucifera Linn. (Palmae) husk fiber extract. Res Microbiol. 
2002;153(10):647-652. doi:10.1016/s0923-2508(02)01377-3 

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5) Kim S, Jang JE, Kim J, et al. Enhanced barrier functions and anti-inflammatory effect of 
cultured coconut extract on human skin. Food Chem Toxicol. 2017;106(Pt A):367-375. 
doi:10.1016/j.fct.2017.05.060 
6) World Bank Commodities Price Data (The Pink Sheet). Commodity Prices. 
https://thedocs.worldbank.org/en/doc/5d903e848db1d1b83e0ec8f744e55570-
0350012021/related/CMO-Pink-Sheet-July-2021.pdf. Published July 2, 2021. Accessed July 
13, 2021.  
7)  "Crops". FAOSTAT. Retrieved 18 December 2020. Countries - Select All; Regions - World 
+ (Total); Elements - Production Quantity; Items - Coconuts; Years - 2018 + 2017 + 2016 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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15.0 Appendix 1 
Participant Survey: 
Circle your answer to the questions below.  
 
Ultrasound Gel: 
1) The ultrasound gel used during the scan was messy. 
 
Strongly Disagree 
Disagree 
Undecided 
Agree 
Strongly Agree 
 
2) I experienced itching/burning/redness from the ultrasound gel used during the scan. 
 
Strongly Disagree 
Disagree 
Undecided 
Agree 
Strongly Agree 
 
3) The ultrasound gel was easy to remove after the scan. 
 
Strongly Disagree 
Disagree 
Undecided 
Agree 
Strongly Agree 
 
4) I like how my skin feels after using the ultrasound gel. 
 
Strongly Disagree 
Disagree 
Undecided 
Agree 
Strongly Agree 
 
5) I would have a scan with the ultrasound gel again. 
 
Strongly Disagree 
Disagree 
Undecided 
Agree 
Strongly Agree 
 
Coconut Oil: 
1) The coconut oil used during the scan was messy. 
 
Strongly Disagree 
Disagree 
Undecided 
Agree 
Strongly Agree 
 
2) I experienced itching/burning/redness from the coconut oil used during the scan. 
 
Strongly Disagree 
Disagree 
Undecided 
Agree 
Strongly Agree 
 
3) The coconut oil was easy to rub in after the scan. 
 
Strongly Disagree 
Disagree 
Undecided 
Agree 
Strongly Agree 
 
4) I like how my skin feels after using the coconut oil. 
 
Strongly Disagree 
Disagree 
Undecided 
Agree 
Strongly Agree 
 
5) I would have a scan with the coconut oil again. 
 
Strongly Disagree 
Disagree 
Undecided 
Agree 
Strongly Agree