Use of Cinnamomum Verum for Induction of Labor. Double Blind Randomized Clinical Trial

• Status: Recruiting
• Trial end date: 2024-10-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Universidad Nacional Autonoma de Honduras

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