Coconut Oil vs. Commercial Ultrasound Gel In Obstetric Ultrasounds
Condition: Pregnancy, High Risk
Study type: Interventional

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.
    

Intervention name(s): Coconut Oil; Commercial Ultrasound Gel
Intervention type(s): Device; Device
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Care Provider)
Primary purpose: Other
Keywords: ultrasonography; coconut oil; ultrasound gel