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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Labor Onset and Length Abnormalities; First Birth
• Intervention / Treatment: Drug: Cinnamomum Verum oil extract; Drug: Placebo

Detailed 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)

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ricardo A. Gutierrez Ramirez, MD, MSc; Phone Number: +50497546940; Email: ricardo.gutierrez@unah.edu.hn
• Study Contact Backup: Name: Yadira Diaz Tilguant, MD; Phone Number: +50488626004; Email: yadira.diaz@unah.edu.hn

Study Locations

• Honduras
  • Francisco Morazan
    • Tegucigalpa, Francisco Morazan, Honduras, 11101
      • Recruiting
      • Hospital Escuela
      • Contact: Yadira Diaz Tilguant, MD; Phone Number: +50488626004; Email: yadira.diaz@unah.edu.hn
      • Contact: Ricardo A. Gutierrez Ramirez, MD; Phone Number: +50497546940; Email: ricardo.gutierrez@unah.edu.hn
      • Principal Investigator: Ricardo A. Gutierrez Ramirez, MD, MSc
      • Sub-Investigator: Yadira Diaz Tilguant, MD
      • Sub-Investigator: Maura C. Bustillo, MD
      • Sub-Investigator: Amanda Lopez Picado, Pharm.D, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 1000 mg orally of Cinnamomum Verum oil extract per day for 21-28 days	Drug: Cinnamomum Verum oil extract; one capsule of 1000 mg orally of Cinnamomum Verum oil extract per day for 21-28 days; Other Names: cinnamon oil
Placebo Comparator: Placebo; 400 mg orally of canola oil per day for 21-28 days	Drug: Placebo; 400 mg PO Canola oil soft gel capsule; Other Names: Canola oil; Kitchen oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Onset of labor	change in the time of onset of physiological phase 3 of the uterus (onset of labor)	21-28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration on labor	change in duration of labor	24 hours
cesarean section and/or instrumental delivery	change in the rate of cesarean section and/or instrumental delivery	1-2 hours
Neonatal complications	change of neonatal complications (apgar less than 7 at 5 minutes, meconium aspiration syndrome)	28 days
macrosomia	change in incidence of macrosomia	1 hour

Collaborators and Investigators

• Sponsor: Universidad Nacional Autonoma de Honduras
• Investigators: Principal Investigator: Ricardo A. Gutierrez Ramirez, MD, MSc, Universidad Nacional Autonoma de Honduras

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2023
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): October 30, 2024

Study Registration Dates

• First Submitted: December 1, 2023
• First Submitted That Met QC Criteria: December 1, 2023
• First Posted (Actual): December 11, 2023

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: nulliparity; cinnamon oil, bark; labor onset
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: CV-LT-01-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all the results
• IPD Sharing Time Frame: 1 year
• IPD Sharing Access Criteria: web data base
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes