Status:
RECRUITING
Use of Cinnamomum Verum for Induction of Labor. Double Blind Randomized Clinical Trial
Lead Sponsor:
Universidad Nacional Autonoma de Honduras
Conditions:
Labor Onset and Length Abnormalities
First Birth
Eligibility:
FEMALE
14-45 years
Phase:
PHASE2
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 ...
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)...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06164613
Start Date
December 4 2023
End Date
December 30 2026
Last Update
December 4 2025
Active Locations (1)
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1
Hospital Escuela
Tegucigalpa, Francisco Morazán Department, Honduras, 11101