Coconut Oil vs. Commercial Ultrasound Gel In Obstetric Ultrasounds

NCT ID: NCT05653362

Last Updated: 2023-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2021-12-22

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.

Conditions

Pregnancy, High Risk

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Coconut Oil followed by 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.

Group Type: OTHER

Coconut Oil

Intervention Type: 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.

Commercial Ultrasound Gel

Intervention Type: DEVICE

Room-temperature Aquasonic 100 (Parker Laboratories, Inc., Fairfield, NJ) applied to patients' abdomen during the ultrasound to serve an another conducting medium.

Commercial Ultrasound Gel followed by Coconut Oil

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.

Group Type: OTHER

Coconut Oil

Intervention Type: 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.

Commercial Ultrasound Gel

Intervention Type: DEVICE

Room-temperature Aquasonic 100 (Parker Laboratories, Inc., Fairfield, NJ) applied to patients' abdomen during the ultrasound to serve an another conducting medium.

Interventions

Coconut 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.

Intervention Type: DEVICE

Commercial Ultrasound Gel

Room-temperature Aquasonic 100 (Parker Laboratories, Inc., Fairfield, NJ) applied to patients' abdomen during the ultrasound to serve an another conducting medium.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Caroline Rouse

Assistant professor of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Caroline Rouse, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University Department of Maternal Fetal Medicine

Locations

Riley Hospital for Children at IU Health

Indianapolis, Indiana, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 15724344 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21771462 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 4670656 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12558183 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

12932

Identifier Type: -

Identifier Source: org_study_id