Use of Cinnamomum Verum for Induction of Labor. Double Blind Randomized Clinical Trial

Labor Onset and Length Abnormalities Clinical Trial

— CINNALAB  

Official title:

Use of Cinnamomum Verum Extract Versus Placebo for Induction of Labor and Reduction of Physiological Phase 2-3 of Labor. Double-blind Randomized Clinical Trial. CINNALAB TRIAL

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06164613
• Other study ID #: CV-LT-01-2023
• Status: Recruiting
• Phase: Phase 2
• Start date: December 4, 2023
• Est. completion date: October 30, 2024

Study information

• Verified date: April 2024
• Source: Universidad Nacional Autonoma de Honduras
• Contact: Ricardo A. Gutierrez Ramirez, MD, MSc
• Phone: +50497546940
• Email: ricardo.gutierrez[@]unah.edu.hn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the research protocol is to evaluate the effectiveness of Cinnamomum verum extract for the initiation of labor. Cinnamaldehyde ((E)-3-Phenylprop-2-enal) is an α, β unsaturated aromatic aldehyde, derived from cinnamon (Cinnamomum Verum oil) used as a flavoring; It is a clear yellowish liquid substance, with a strong odor and flavor. It is the main component of cinnamon (63%), giving it its physicochemical properties. Cinnamon has been an element of empirical use for the beginning of labor, however, its effectiveness has not been demonstrated. Cinnamon has been reported for its ethnopharmacological properties in pregnancy, being used to facilitate childbirth, as a lactagogue and for postpartum recovery. In Honduras, its use has been reported to relieve nausea and vomiting during pregnancy, to reduce abdominal pain. , reduction of lower limb edema, to relieve anxiety during labor, as well as a lactagogue without convergent opinions.

Description:

clinical trial of parallel groups of effectiveness, 2 groups will be taken, the intervention group will be administered capsules of Cinnamomum verum concentrate (1000 mg orally per day, a single dose) containing 67% cinnamaldehyde, one capsule per day will be administered (oral dose cinnamaldehyde lethal dose (LD50) of 1.15 g/kg), each capsule contains 1000 mg of Cinnamomum verum bark concentrate in soft gelatin capsules which are odorless and tasteless. The control group will be administered canola oil capsules, a dose of 400 mg orally per day, a single dose per day. These soft gelatin capsules are odorless and tasteless. Both capsules have identical physical characteristics. (they are soft gelatin capsules with the same color and smell)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: October 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Delivery of an informed consent form signed and dated by parents or guardian and patient

2. Declared willingness to comply with all study procedures and availability for the duration of the study.

3. provision of appropriate consent and assent

4. Willingness and ability to participate in study procedures

5. Patients under 18 years of age

6. Full-term pregnancies (37-41 Weeks of Gestation).

7. Nulliparity

8. Have your own cell phone

9. Know how to read and write

10. Residing in Tegucigalpa

11. Be in good general health, as evidenced by your medical history

12. Ultrasound with amniotic fluid index > 5 cm

13. Non Stress Test Reactive

14. Ability to take oral medication and be willing to comply with the cinnamon capsule regimen

Exclusion Criteria:

1. Current use of antihypertensive or hypoglycemic medications

2. Presence of non-curable chronic diseases prior to pregnancy or during pregnancy such as hypertension, diabetes, hypothyroidism

3. Premature rupture of membranes

4. Infections (urinary tract infection, chorioamnionitis) present at the time of the study (diagnosed with symptoms or leukocytes >12,500 or pathological urine examination)

5. Allergies to cinnamaldehyde or cinnamon, canola oil

6. Multiple pregnancy

7. Major fetal malformations

8. Fetal death

9. Non-cephalic presentation

10. Severe oligohydramnios (amniotic fluid index < 2 cm)

11. Having consumed or being consuming cinnamon products 7 days before the start of the study

12. Febrile illness within 7 days before starting to take cinnamon

13. Treatment with another investigational drug or other intervention within 7 days prior to the start of the intervention

14. Current smoker or tobacco use

Related Conditions & MeSH terms

• Congenital Abnormalities
• First Birth
• Labor Onset and Length Abnormalities

Intervention

Drug:
• Cinnamomum Verum oil extract
one capsule of 1000 mg orally of Cinnamomum Verum oil extract per day for 21-28 days
• Placebo
400 mg PO Canola oil soft gel capsule

Locations

Country	Name	City	State
Honduras	Hospital Escuela	Tegucigalpa	Francisco Morazan

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Nacional Autonoma de Honduras

Country where clinical trial is conducted

Honduras, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Onset of labor	change in the time of onset of physiological phase 3 of the uterus (onset of labor)	21-28 days
Secondary	duration on labor	change in duration of labor	24 hours
Secondary	cesarean section and/or instrumental delivery	change in the rate of cesarean section and/or instrumental delivery	1-2 hours
Secondary	Neonatal complications	change of neonatal complications (apgar less than 7 at 5 minutes, meconium aspiration syndrome)	28 days
Secondary	macrosomia	change in incidence of macrosomia	1 hour