Use of Cinnamomum Verum for Induction of Labor. Double Blind Randomized Clinical Trial
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
Universidad Nacional Autonoma de Honduras
70 participants
Dec 4, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria14
- 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 Criteria14
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
one capsule of 1000 mg orally of Cinnamomum Verum oil extract per day for 21-28 days
400 mg PO Canola oil soft gel capsule
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06164613