Clinical trial NCT06164613: Use of Cinnamomum Verum for Induction of Labor. Double Blind Randomized Clinical Trial
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Labor Onset and Length Abnormalities
First Birth
Keywords: cinnamon oil, bark
labor onset
nulliparity
Lead sponsor: Universidad Nacional Autonoma de Honduras
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 32
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel group, efficacy, randomized, placebo-controlled, double-blind clinical trial.
Primary purpose: OTHER

Brief 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.

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)

Eligibility criteria: 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

Primary outcomes:
measure: Onset of labor
timeFrame: 21-28 days
Secondary outcomes:
measure: duration on labor
timeFrame: 24 hours
measure: cesarean section and/or instrumental delivery
timeFrame: 1-2 hours
measure: Neonatal complications
timeFrame: 28 days
measure: macrosomia
timeFrame: 1 hour
Other outcomes:
Locations:
city: Tegucigalpa
country: Honduras
facility: Hospital Escuela
state: Francisco Morazan
Study officials:
affiliation: Universidad Nacional Autonoma de Honduras
name: Ricardo A. Gutierrez Ramirez, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: