Using cinnamon extract to help start labor in first-time mothers

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

This study tests if cinnamon extract can help first-time mothers start labor safely and effectively when they are at full-term.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 14 Years to 45 Years
• Sex: Female
• Sponsor: Universidad Nacional Autonoma de Honduras (other)
• Locations: 1 site (Tegucigalpa, Francisco Morazán Department)
• Trial ID: NCT06164613 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of Cinnamomum verum extract in inducing labor for first-time mothers. Participants will be randomly assigned to receive either cinnamon extract capsules or placebo capsules containing canola oil. The study aims to determine if the cinnamon extract can safely and effectively initiate labor in women who are at full-term pregnancy. The trial will monitor the onset and length of labor in both groups to assess the potential benefits of this natural remedy.

Who should consider this trial

Good fit: Ideal candidates for this study are first-time mothers, aged under 18, who are at full-term pregnancy and in good general health.

Not a fit: Patients with chronic diseases or those currently using antihypertensive or hypoglycemic medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a natural method for inducing labor in first-time mothers, potentially reducing the need for medical interventions.

How similar studies have performed: While cinnamon has been used traditionally for labor induction, this specific approach has not been extensively tested in clinical settings, making it a novel investigation.

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

Where this trial is running

Tegucigalpa, Francisco Morazán Department

• Hospital Escuela — Tegucigalpa, Francisco Morazán Department, Honduras (RECRUITING)

Study contacts

• Principal investigator: Ricardo A. Gutierrez Ramirez, MD, MSc — Universidad Nacional Autonoma de Honduras
• Study coordinator: Ricardo A. Gutierrez Ramirez, MD, MSc

Conditions: Labor Onset and Length Abnormalities, First Birth, cinnamon oil, bark, labor onset, nulliparity