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New treatment option for Labor Onset and Length Abnormalities
Official title Use of Cinnamomum Verum for Induction of Labor. Double Blind Randomized Clinical Trial
ClinicalTrials.gov ID: NCT06164613
What this study is testing
What is Cinnamomum Verum oil extract?
Cinnamomum Verum oil extract is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for labor onset and length abnormalities.
Also referred to as cinnamon oil.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 45, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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...
- Allergies to cinnamaldehyde or cinnamon, canola oil
- Multiple pregnancy
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Tegucigalpa, Francisco Morazán Department, Honduras
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 14 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tegucigalpa, Francisco Morazán Department, Honduras. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.