Clary Sage Essential Oil & Pregnancy

Study Overview
=================
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.

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.

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

Conditions
-----------------
Quality of Life, Pregnancy Related

Intervention / Treatment
-----------------
* Other: Clary Sage Massage Oil
* Other: Inert Massage Oil


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 39 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* This massage oil contains clary sage oil. Five drops will be used daily.<br>|
| Placebo Comparator: Control<br>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<br>* This massage oil consists entirely of plant based oils. Five drops will be used daily.<br>|

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. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Pregnancy | 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 | The total length of phase 2 of labor (in minutes) | from the onset of labor to birth, up to 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
clary sage, essential oil, aromatherapy