RANDOMIZED DOUBLE-BLIND CLINICAL TRIAL TO MEASURE THE EFFICACY OF ACTAEA RACEMOSA (9CH) AND CAULOPHYLLUM THALICTROIDES (9CH) IN THE FIRST STAGE OF LABOR

Phase 1

• Conditions: First stage of labor; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2015-001548-13-ES
• Lead Sponsor: BOIRONSIH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-10
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 114

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified