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montserrat zamora brito -More
Category
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Primary study
Registry of Trials»EU Clinical Trials Register
Year
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2017
INTERVENTION: 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 español y ficha técnica . Product Name: acupunture Product Code: ES14/16797 Pharmaceutical Form: Cutaneous stick INN or Proposed INN: Agujas CAS Number: agujas Current Sponsor code: agujas Other descriptive name: agujas Concentration unit: Other Concentration type: range Concentration number: 1‐2 CONDITION: Therapeutic area: Health Care [N] ‐ Health Services Administration [N04] 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. PRIMARY OUTCOME: 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 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%. 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 Timepoint(s) of evaluation of this end point: Difference in hours between scheduled income and actual income. SECONDARY OUTCOME: 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 or before hospital admission.; ? Induction method after induction failure with acupuncture according to the induction protocol at birth. Foley catheter, Misoprothol, Dinoprostone, Oxytocin.; Foley probe time if this method is used for cervical maturation if acupuncture induction fails in minutes.; ? Doses of misoprotol (50mcg dose) used.; ? Dinoprostone time in minutes.; ? Oxytocin time in minutes.; ? Premature rupture of membranes: yes / no; Day and hour. Premature rupture of membranes (RPM) means the rupture of the ovular membranes before the onset of labor, with the consequent release of amniotic fluid.; ? Intrapartum amniorrexis: spontaneous or artificial.; ? Characteristics of amniotic fluid defined as clear, blood or meconium.; ? Epidural anesthesia: yes / no.; ? Duration in minutes of each stage of labor: dilation, expulsion, and delivery.; ? Type of delivery: eutocic, vacuum, spatulas, forceps, cesarean in the course of delivery, urgent cesarean section.; ? Reason for instrumented delivery / cesarean delivery.; ? Use of betamimetics: yes / no.; ? Treatment side effects by specifying the types of treatment used with either acupuncture or Foley, Misoprostol, Dinoprostone, Oxytocin treatments.; ? Maternal complications: yes / no uterine rupture, yes / no postpartum haemorrhage. Minor postpartum haemorrhage (HPP) is defined as a hemorrhagic loss between 500 and 1000 ml with no clinical signs of shock ml. SE is defined as a higher PPH when the patient continues to bleed, or the estimate is> 1000 ml or, given a lower estimate, presents clinical signs of shock.; ? Neonatal outcomes: sex (male, female); Weight expressed in grams; Apgar test score at minutes 1 and 5 of extrauterine life; Arterial pH of umbilical cord, expressed in a single figure with two decimal places; Advanced resuscitation yes / no; Admission to Neonatal Unit yes / no, cause of neonatal admission.; ? Degree of satisfaction of pregnant women Timepoint(s) of evaluation of this end point: Induction at birth in low‐ and middle‐risk pregnant women through acupuncture; ; Could reduce the number of hospital admissions in the group of pregnant women with the increased risk of perinatal mortality, as in chronologically prolonged gestation, and specifically in the body mass index 30% and the maternal age of More than 40 years, by 20% 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
Epistemonikos ID: c6fc15edc56b083320d359dfc841eb00ad6d4a6f
First added on: Dec 20, 2022