First stage of labor
Conditions
Interventions
Trade Name: Actaea racemosa (9CH)
Pharmaceutical Form: Granules
Pharmaceutical form of the placebo: Granules
Route of administration of the placebo: Sublingual use
Trade Name: Caulophyllum thalicthro
Sponsors
BOIRONSIH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Women above 18 years old. 2. Pregnant women between 32 and 33 weeks gestation. The calculation of gestational age was performed using the date of the last rule corrected estimated by ultrasound parameters of the first ultrasound age. If the estimated age by ultrasound exceeds 7 days estimated by last menstrual period, it will assume the sonographically estimated as correct. 3. Carrier single fetus in cephalic presentation at the time of recruitment. 4. Compliance of pregnant women to participate in this study by signing the informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 114 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Women who have undergone cesarean in a previous pregnancy. 2. Women who are being treated with medications for chronic disease. 3. Women who have had gestational diabetes during this pregnancy (diabetes, hypertension, urinary tract infection present, severe anemia) and / or present a pregnancy of moderate / high risk. 4. Presence of fetal pathology (malformations, intrauterine growth retardation, etc.) 5. Presence of placental abnormalities (single umbilical artery, placental insufficiency, placenta previa, etc.) 6. Presence of current or resolved in less than 15 days time fetal or maternal infection. 7. Bleeding disorder mother of the third quarter. 8. Women with severe mental illness. 9. Women who have decided to give birth by elective Caesarean section. 10. Women who suffer from lactose intolerance. 11. Women whose condition does not make them eligible for the study, according to the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine the efficacy of treatment with Actaea racemosa (9CH) and Caulophyllum thalicthroides (9CH) from the 37th week of pregnancy in the first stage of labor compared with placebo treatment.;Secondary Objective: Analyze the duration of latent phase in the group of women who take homeopathic treatment compared to the group taking placebo. 2. Analyze the total duration of labor 3. To analyze the evolution of cervical ripening 4. Analyze the proportion of instrumental delivery being made after the homeopathic treatment compared to the placebo group. 5. Analyze the proportion of caesarean sections, complications during labor, premature rupture of membranes and use of oxytocin during labor, 6. Analyze the vitality of the newborn of mothers who took homeopathic medicines and mothers who took the placebo. 7. Analyze the participant satisfaction after taking the homeopathic treatment compared to the group taking the placebo once delivery is completed. 8. To analyze the safety and tolerability of the investigational treatments.;Primary end point(s): The primary endpoint is the duration of the first stage of labor.;Timepoint(s) of evaluation of this end point: During the first satage of labor | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Duration latent phase of the first stage of labor ? total time duration of labor ? Changes in cervical ripening: Test score modified Bishop. ? Administration of oxytocin as a regulator of the dynamic once work has started spontaneously birth: ? Evaluation of the use of ? Cesarean: Complications during delivery: ? Premature rupture of membranes: ? Induction of labor (drugs, Hamilton maneuver, amniotomy, etc): Type of anesthesia used during delivery and instant start. ? instrumental delivery: ? APGAR test score at one minute and five minutes of birth. ? Height, weight and head circumference of the newborn. ? Satisfaction survey of pregnant women. ? Clinical Obstetric history: ? socio-demographic variables: ? blood safety variables: liver function (transaminases), renal profile (creatinine and urea) and CBC. ? Incidence and severity of adverse events during the study.;Timepoint(s) of evaluation of this end point: During delivery | — |
Countries
Spain
Contacts
Public ContactCLINICAL TRIAL INFORMATION
QUANTUM EXPERIMENTAL, S.L.
Outcome results
None listed