Coconut Oil vs. Commercial Ultrasound Gel In Obstetric Ultrasounds

NCT05653362 | Completed Results FDA Device

• 1 other identifier: 12932
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. 1.To evaluate the quality of ultrasound images obtained using coconut oil compared with commercial ultrasound gel.
2. 2.To access patient acceptability of coconut oil as compared to commercial ultrasound gel.
3. 3.Allow a total of 6 study images to be obtained; 3 using coconut oil and 3 with commercial ultrasound gel.
4. 4.Fill out a 10-question, 5-point Likert scale survey following their ultrasound with both coupling mediums to compare acceptability.

Conditions

Pregnancy, High Risk

Keywords

ultrasonography; coconut oil; ultrasound gel

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Acceptability

  after ultrasound scanning, an average of 1 hour

Study Arms (2)

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.

Device: Coconut Oil; Device: Commercial Ultrasound Gel

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.

Device: Coconut Oil; Device: Commercial Ultrasound Gel

Interventions

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.

Coconut Oil followed by Commercial Ultrasound Gel; Commercial Ultrasound Gel followed by Coconut Oil

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.

Coconut Oil followed by Commercial Ultrasound Gel; Commercial Ultrasound Gel followed by Coconut Oil

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Allergy to coconut
• Active inflammatory dermatologic conditions (dermatitis, eczema, or psoriasis)
• Multiple gestation pregnancy

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Riley Hospital for Children at IU Health

Indianapolis, Indiana, 46202, United States

Location

Related Publications (4)

• 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.

  PMID: 15724344 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.

  PMID: 21771462 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.

  PMID: 4670656 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.

  PMID: 12558183 BACKGROUND

Limitations and Caveats

Technicians and patients were not blinded. This study was performed at a single site.

Results Point of Contact

• Title: Claire Edelman
• Organization: Indiana University School of Medicine

ceedelma@iu.edu

3176509107

Study Officials

• Caroline Rouse, MD

  Indiana University Department of Maternal Fetal Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: December 16, 2022
• Study Start: December 1, 2021
• Primary Completion: December 22, 2021
• Study Completion: December 22, 2021
• Last Updated: June 2, 2023
• Results First Posted: June 2, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)