Use of Cinnamomum Verum for Induction of Labor.

Study Overview
=================
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)

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

Conditions
-----------------
Labor Onset and Length Abnormalities, First Birth

Intervention / Treatment
-----------------
* Drug: Cinnamomum Verum oil extract
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Delivery of an informed consent form signed and dated by parents or guardian and patient Declared willingness to comply with all study procedures and availability for the duration of the study. provision of appropriate consent and assent Willingness and ability to participate in study procedures Patients under 18 years of age Full-term pregnancies (37-41 Weeks of Gestation). Nulliparity Have your own cell phone Know how to read and write Residing in Tegucigalpa Be in good general health, as evidenced by your medical history Ultrasound with amniotic fluid index > 5 cm Non Stress Test Reactive Ability to take oral medication and be willing to comply with the cinnamon capsule regimen Exclusion Criteria: Current use of antihypertensive or hypoglycemic medications Presence of non-curable chronic diseases prior to pregnancy or during pregnancy such as hypertension, diabetes, hypothyroidism Premature rupture of membranes Infections (urinary tract infection, chorioamnionitis) present at the time of the study (diagnosed with symptoms or leukocytes >12,500 or pathological urine examination) Allergies to cinnamaldehyde or cinnamon, canola oil Multiple pregnancy Major fetal malformations Fetal death Non-cephalic presentation Severe oligohydramnios (amniotic fluid index < 2 cm) Having consumed or being consuming cinnamon products 7 days before the start of the study Febrile illness within 7 days before starting to take cinnamon Treatment with another investigational drug or other intervention within 7 days prior to the start of the intervention Current smoker or tobacco use

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: parallel group, efficacy, randomized, placebo-controlled, double-blind clinical trial.
Masking: Triple


Arms and Interventions

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cinnamon oil, bark, labor onset, nulliparity