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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Onset of labor
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 14 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intervention
1000 mg orally of Cinnamomum Verum oil extract per day for 21-28 days
干预措施: Cinnamomum Verum oil extract (Drug)
Placebo
400 mg orally of canola oil per day for 21-28 days
干预措施: Placebo (Drug)
结局指标
主要结局
Onset of labor
时间窗: 21-28 days
change in the time of onset of physiological phase 3 of the uterus (onset of labor)
次要结局
- duration on labor(24 hours)
- cesarean section and/or instrumental delivery(1-2 hours)
- Neonatal complications(28 days)
- macrosomia(1 hour)
研究者
Ricardo A Gutierrez Ramirez, MD, MSc, FACOG
Professor, research coordinator of the postgraduate course in gynecology and obstetrics
Universidad Nacional Autonoma de Honduras