Health Trials

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

ConditionsLabor Onset and Length AbnormalitiesFirst Birth
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age14-45
SponsorUniversidad Nacional Autonoma de Honduras

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cinnamomum Verum oil extract

    Drug

    one capsule of 1000 mg orally of Cinnamomum Verum oil extract per day for 21-28 days

  • Placebo

    Drug

    400 mg PO Canola oil soft gel capsule

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Onset of labor

change in the time of onset of physiological phase 3 of the uterus (onset of labor)

Time frame
21-28 days

Secondary outcomes

1

duration on labor

change in duration of labor

Time frame
24 hours
2

cesarean section and/or instrumental delivery

change in the rate of cesarean section and/or instrumental delivery

Time frame
1-2 hours
3

Neonatal complications

change of neonatal complications (apgar less than 7 at 5 minutes, meconium aspiration syndrome)

Time frame
28 days
4

macrosomia

change in incidence of macrosomia

Time frame
1 hour

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidad Nacional Autonoma de Honduras

Lead sponsor

Source ClinicalTrials.gov
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