Clary Sage Essential Oil & Pregnancy
Clary Sage Essential Oil Inhalation and Third Trimester Quality of Life: A Randomized, Double Blind, Controlled Trial
1 other identifier
interventional
50
1 country
1
Brief Summary
The purpose of this study is to evaluate the potential for clary sage essential oil to support overall health, wellbeing, and quality of life during the third trimester of pregnancy among otherwise healthy adult women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable quality-of-life
Started Nov 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2021
CompletedFirst Posted
Study publicly available on registry
August 11, 2021
CompletedStudy Start
First participant enrolled
November 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2023
CompletedMay 2, 2022
April 1, 2022
1.2 years
July 26, 2021
April 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in salivary estriol levels from pregnancy week 27 to pregnancy week 36.
salivary estriol levels are collected via the passive drool method and laboratory analyzed
Pregnancy week 27 and 36
Change in quality of life from week 27 to 36 of the pregnancy using the World Health Organization's Quality of Life, Brief-Form Scale (WHOQOL-BREF).
This one survey measures overall quality of life through. It contains 26 questions across 4 domains. Questions are scored on a 1-5 likert scale with higher scores indicating higher quality of life.
Pregnancy week 27 and 36
Secondary Outcomes (2)
Duration of Pregnancy
from enrollment to birth, up to 16 weeks
Duration of phase 2 of labor
from the onset of labor to birth, up to 24 hours
Study Arms (2)
Intervention
EXPERIMENTALParticipants in this group will receive a fragrant plant based massage oil with the addition of clary sage essential oil. The massage oil will be massaged into the upper thighs daily for the duration of the third trimester.
Control
PLACEBO COMPARATORParticipants in this group will receive a fragrant plant based massage oil. The massage oil will be massaged into the upper thighs daily for the duration of the third trimester.
Interventions
This massage oil contains clary sage oil. Five drops will be used daily.
This massage oil consists entirely of plant based oils. Five drops will be used daily.
Eligibility Criteria
You may qualify if:
- Age 20-39
- Lives in the United States
- Pregnant, singleton
- Low risk
- Less than 27 weeks gestation
You may not qualify if:
- PCOS diagnosis
- Uncontrolled Hypertension (i.e. systolic/diastolic blood pressure \> 140/90)
- Gestational Diabetes
- History of Preeclampsia
- Preterm labor
- Incompetent cervix
- Allergy to salvia sclarea or related plants
- Known Birth Defects
- Thyroid Disease diagnosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Franklin Health Research Center
Franklin, Tennessee, 37067, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2021
First Posted
August 11, 2021
Study Start
November 1, 2021
Primary Completion
December 31, 2022
Study Completion
February 28, 2023
Last Updated
May 2, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share