Clary Sage Essential Oil & Pregnancy

April 29, 2022 updated by: Franklin Health Research

Clary Sage Essential Oil Inhalation and Third Trimester Quality of Life: A Randomized, Double Blind, Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Women will be informed of the opportunity to participate through their care providers, childbirth educators, or doulas. If they meet inclusion criteria, they will be given a brochure describing the risks and benefits of the study and the informed consent paperwork.

If they provide consent, they will be randomized to one of two groups: active essential oil and inert placebo. Both groups will receive a 4-ounce bottle of oil to apply daily during the third trimester of pregnancy. Those in the placebo group will be given an inert plant oil. Those in the intervention group will be given the same oil with the addition of clary sage essential oil.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Recruiting
        • Franklin Health Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 39 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age 20-39
  • Lives in the United States
  • Pregnant, singleton
  • Low risk
  • Less than 27 weeks gestation

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Participants 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.
Other: Clary Sage Massage Oil
This massage oil contains clary sage oil. Five drops will be used daily.
Placebo Comparator: Control
Participants 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.
Other: Inert Massage Oil
This massage oil consists entirely of plant based oils. Five drops will be used daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in salivary estriol levels from pregnancy week 27 to pregnancy week 36.
Time Frame: Pregnancy week 27 and 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).
Time Frame: Pregnancy week 27 and 36
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Pregnancy
Time Frame: from enrollment to birth, up to 16 weeks
The total length of the pregnancy (in days) from last menstrual period to birth.
from enrollment to birth, up to 16 weeks
Duration of phase 2 of labor
Time Frame: from the onset of labor to birth, up to 24 hours
The total length of phase 2 of labor (in minutes)
from the onset of labor to birth, up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Franklin Health Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

February 28, 2023

Study Registration Dates

First Submitted

July 26, 2021

First Submitted That Met QC Criteria

August 3, 2021

First Posted (Actual)

August 11, 2021

Study Record Updates

Last Update Posted (Actual)

May 2, 2022

Last Update Submitted That Met QC Criteria

April 29, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro00055623

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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