Clary Sage Essential Oil & Pregnancy

Not Applicable

• Conditions: Quality of Life; Pregnancy Related
• Interventions: Other: Inert Massage Oil; Other: Clary Sage Massage Oil

• Registration Number: NCT05000424
• Lead Sponsor: Franklin Health Research

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.

Study Timeline

• Study First Submitted: 2021-07-26
• Study First Submitted QC: 2021-08-03
• Study First Posted: 2021-08-11
• Study Start: 2021-11-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-29
• Last Update Posted: 2022-05-02
• Primary Completion: 2022-12-31
• Study Completion: 2023-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Inert Massage Oil	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.
Intervention	Clary Sage Massage Oil	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.

Primary Outcome Measures

Name	Time	Method
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).	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.
Change in salivary estriol levels from pregnancy week 27 to pregnancy week 36.	Pregnancy week 27 and 36	salivary estriol levels are collected via the passive drool method and laboratory analyzed

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Franklin Health Research Center; 🇺🇸 Franklin, Tennessee, United States