First Birth, Labor Onset and Length Abnormalities
Conditions
Keywords
cinnamon oil, bark, labor onset, nulliparity
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)
Interventions
DRUGCinnamomum Verum oil extract
one capsule of 1000 mg orally of Cinnamomum Verum oil extract per day for 21-28 days
DRUGPlacebo
400 mg PO Canola oil soft gel capsule
Sponsors
Universidad Nacional Autonoma de Honduras
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
The masking of the treatment will be carried out by a person external to the study; in this sense, white bottles with orange and green labels will be used. To mask the cinnamon smell of the capsule, the preparation in soft gelatin capsules with cinnamon oil will be used. This preparation, since the capsule is sealed, has no smell or flavor. For the placebo, soft gelatin capsules containing canola oil will be used.
Intervention model description
parallel group, efficacy, randomized, placebo-controlled, double-blind clinical trial.
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Onset of labor | 21-28 days | change in the time of onset of physiological phase 3 of the uterus (onset of labor) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| duration on labor | 24 hours | change in duration of labor |
| cesarean section and/or instrumental delivery | 1-2 hours | change in the rate of cesarean section and/or instrumental delivery |
| Neonatal complications | 28 days | change of neonatal complications (apgar less than 7 at 5 minutes, meconium aspiration syndrome) |
| macrosomia | 1 hour | change in incidence of macrosomia |
Countries
Honduras
Contacts
Primary ContactRicardo A. Gutierrez Ramirez, MD, MSc
Backup ContactYadira Diaz Tilguant, MD
Outcome results
None listed