This Clinical Trial will evaluate the efficacy and safety of acupuncture to promote labor in pregnant women who need an induction at birth and thus be able to give answers to all these women who are increasingly seeking these therapies, such as acupuncture, pregnancy and Childbirth together with usual medical practice.
Conditions
Interventions
Trade Name: Acupuncture ES14/169797 Directive 93/42/EEC
ES / MAD 200839
Principio activo: agujas acupuntura.
Agujas de aceroinoxidable estériles.ISO7153-1para material quirúrgico.Adjunto etiquetado es
Sponsors
montserrat zamora brito
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Low- and medium-risk term pregnant women (not including pregnant women under age 18, grade I heart disease, high multiparity, and insufficient gestational control) between 40-41 w 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 117 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pregnant women who do not want to participate in the project. * Mid-risk pregnant women out of the inclusion criteria, high and very high risk. * Pregnant women who do not understand the language. * Pregnant women whose delivery attendance is not going to be performed in our Hospital ( Clínic Hospital of Barcelone ) * Pregnant women with anomalous fetal presentations according to the ultrasound of the third trimester: transverse, oblique and breech. * Premature rupture of membranes before initiating intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effectiveness of acupuncture for the reduction of the rate of programmed admissions in medicalized inductions in low- and medium-risk pregnant women between 40-42 w;Secondary Objective: Determine the time from the start of treatment to the beginning of labor * Know if there are differences in the obstetric conditions during treatment, at admission, and during periods of dilation and expulsion with respect to the control group. * To know if there are differences in the neonatal outcomes, the side effects to the treatment and the possible maternal complications between the women of both groups. * Identify if there are differences in alterations in uterine dynamics, risk of loss of fetal wellbeing and use of betamimetic drugs in women of both groups * Know if women in the control group use oxytocin more frequently and at higher doses than those in the experimental group. As well as treatment doses for drug induction at delivery. * Evaluate if there are differences in the number of cesarean sections of both groups. To know the degree of satisfaction of the women of both groups;Primary end point(s): Induction at delivery in low- and middle-risk pregnant women through acupuncture could lead to a reduction in the number of hospital admissions in the group of pregnant women with an increased risk of perinatal mortality, as in chronologically prolonged gestation, and specifically in the body mass index above 30% and maternal age over 40 years old, by 20%.;Timepoint(s) of evaluation of this end point: Difference in hours between scheduled income and actual income. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Demographic data: age, nationality, ethnicity, name, Hª clinic ? Gestational age at delivery, expressed in weeks and days. ? Parity ? Anterior induction and previous type of delivery ? Size expressed in cm ? Weight expressed in grams ? BMI ? Obstetric risk ? Treatment of anterior acupuncture, either pre-gestational or during ongoing gestation. ? Performing any maneuver / method that can trigger labor (nipple stimulation, sexual intercourse, Hamilton maneuver, raspberry infusions, cinnamon, homeopathy ...). ? Professional acupuncturist who treats and values ??the pregnant woman, start date, time, treated points and the duration of the session expressed in minutes. ? Obstetric admission conditions assessed by vaginal touch, taking into account the position, consistency and effacement of the cervix, dilatation of the cervix, and the Hodge plane in which the fetal presentation is. Bishop's Test. ? Information about the fetal cardiotocographic record, which we will catalog according to normal, atypical or pathological according to the fetal wellbeing protocol of Hospital Clinic - Maternidad, before performing the treatment with acupuncture and 60 'post treatment. ? Fetal RCTG Features: Baseline fetal heart rate. Short-term variability and the presence or absence of transient ascents, before performing the treatment with acupuncture and 60 'post-treatment. ? Dynamic Uterine Registry. Changes in uterine dynamics will be assessed: yes / no tachysystole (more than five contractions in ten minutes for at least 20 minutes), yes / no hypertonia (contraction lasting two minutes or more), bradystrothesis yes / no Less than three contractions in ten minutes for at least 20 minutes) dynamic uterine absence. Before performing the treatment with acupuncture and 60 'post-treatment. ? Reason for admission: labor / premature rupture of membranes / others. ? Income according to the expected date: Yes / No ? Number of acupuncture sessions performed prior to labor | — |
Countries
Spain
Contacts
Public ContactFetal Medicine Barcelone
Clinic hospital of Barcelone
Outcome results
None listed