Clary Sage Essential Oil & Pregnancy

Nutraceuticals Research Institute50 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

Quality of Life Pregnancy Related

Interventions

Clary Sage Massage OilOTHER

This massage oil contains clary sage oil. Five drops will be used daily.

Inert Massage OilOTHER

This massage oil consists entirely of plant based oils. Five drops will be used daily.

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 39 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Franklin Health Research Center

Franklin, Tennessee, United States

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: Pregnancy week 27 and 36

Secondary Outcomes

Duration of Pregnancy

The total length of the pregnancy (in days) from last menstrual period to birth.

Time frame: from enrollment to birth, up to 16 weeks

Duration of phase 2 of labor

The total length of phase 2 of labor (in minutes)

Time frame: from the onset of labor to birth, up to 24 hours

Data from ClinicalTrials.gov

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