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Trial record 51 of 1204 for:    acupuncture

Influence of Acupuncture in the Placental Expulsion Time

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ClinicalTrials.gov Identifier: NCT02000752
Recruitment Status : Completed
First Posted : December 4, 2013
Results First Posted : October 26, 2015
Last Update Posted : October 26, 2015
Sponsor:
Information provided by (Responsible Party):
Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias

Brief Summary:

In this study, a single blind randomized trial is carried out in order to compare placental detachment times when Ren Mai 6 is stimulated and when a different placebo point is used. So, a lower detachment time is assumed to be related to a higher uterine contraction, and, therefore, a decrease in the hemorrhage postpartum. We focus on measuring the time it takes to placental delivery due to the fact that, if this point promotes the uterine contraction, then the placental delivery will be produced in a short time. Thus, this technique could decrease the hemorrhage postpartum.

The principal outcome of the study is the placental expulsion time. This time is measured by the midwife who is responsible of the birth, and it considers the time passed between the delivery of the newborn and the complete expulsion of the placenta.

Concerning the secondary outcomes, the application of real acupuncture in Ren Mai 6 point, and sham acupuncture in the placebo point are considered. Their study is derived from the statistical analysis of the results of the principal outcome. The existence of pain related to the treatment and the degree of satisfaction of the mother is also a secondary outcome, analyzed by the survey that the midwife carries out no more than 2 hours after the labor. At last, it is important to highlight that the degree of satisfaction of the midwife is also considered as a secondary outcome, since it is registered in the same survey.


Condition or disease Intervention/treatment Phase
Placental Expulsion Time Device: Acupuncture Device: Sham acupuncture Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Influence of Acupuncture in the Placental Expulsion Time
Study Start Date : April 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: Acupuncture
In the intervention group with real acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the point Ren Mai 6. This point is located on the anterior midline, between the umbilicus and the upper part of the pubic symphysis, at a distance of 0.3d from the umbilicus, being d the distance from the umbilicus to the upper part of the pubic symphysis. A sterilized steel needle of 0.25x40 mm is inserted in this point at 15-30 mm, depending on the adipose tissue of the woman.
Device: Acupuncture
Other Name: acupuncture needles

Sham Comparator: Sham acupuncture
Regarding to the control group with sham acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the placebo point with a sterilized 0.25x40 mm steel needle. The control point is located at the same horizontal level than the Ren Mai 6 point, but at 0.6d to the left of the anterior midline of the mother. In this case, the sterilized steel needle of 0.25x25 mm is inserted 15 mm into the tissue.
Device: Sham acupuncture
Sham point acupuncture
Other Name: acupuncture needles




Primary Outcome Measures :
  1. The Principal Outcome of the Study is the Placental Expulsion Time. [ Time Frame: Up to 30 minutes after the newborn delivery ]
    This time is measured by the midwife who is responsible of the birth, and it considers the time passed between the delivery of the newborn and the complete expulsion of the placenta.


Secondary Outcome Measures :
  1. Percentage of Participants Who Reported Experiencing Pain Related to Treatment [ Time Frame: Measured into the 2 hours after the childbirth but before puerperal woman is moved to the obstetrics plant out of the labor room ]
    The existence of pain related to the treatment is analyzed by the survey that the midwife carries out no more than 2 hours after the labor. A scale with 4 levels was used (no pain, mild pain, moderate pain, great pain).

  2. Percentage of Mothers That Would Recommend the Technique to Any of Her Friends [ Time Frame: Measured into the 2 hours after the childbirth but before puerperal woman is moved to the obstetrics plant out of the labor room ]
    The number of mothers that would recommend the technique to any of her friends is analyzed in the survey that the midwife carries out no more than 2 hours after the labor. The possible responses are "I would recommend it", or "I would not recommend it".

  3. Degree of Ease With Which the Acupuncturist Administered the Treatment [ Time Frame: Measured into the 2 hours after the childbirth but before puerperal woman is moved to the obstetrics plant out of the labor room ]
    The degree of ease with which the acupuncturist administered the treatment was measured in a survey that the midwife carries out no more than 2 hours after the labor. The value was recorded using a numerical scale ranging between 0-100, with 4 levels: "100 - high ease", "75 - moderate ease", "50 - medium ease" and "25 - low ease"



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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Primiparous women between 20 and 35 years old
  • Within 37 and 42 weeks of gestation
  • Low obstetric risk labor
  • With epidural analgesia

Exclusion Criteria:

  • Myomatosis
  • Coagulation disorders
  • Placental alterations (placenta previa or placenta accreta)
  • Uterine overdistension (multiple pregnancy, polyhydramnios or fetal macrosomia)
  • Previous abortions and subject to curettage evacuator.
  • Previous uterine surgeries
  • Prolonged labor (more than 11 hours) or too fast labor (less than 2 hours)
  • Use of uterine relaxants during childbirth (magnesium sulfate or halogenates anaesthetic drugs)
  • People uncapable to give the informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02000752


Locations
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Spain
Hospital Universitario Principe de Asturias
Alcala de Henares, Madrid, Spain, 28805
Sponsors and Collaborators
Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias
Investigators
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Principal Investigator: Beatriz Lopez Garrido, Midwife Hospital Universitario Principe de Asturias

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Responsible Party: Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias
ClinicalTrials.gov Identifier: NCT02000752     History of Changes
Other Study ID Numbers: PI 36/2010
First Posted: December 4, 2013    Key Record Dates
Results First Posted: October 26, 2015
Last Update Posted: October 26, 2015
Last Verified: September 2015
Keywords provided by Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias:
Labor
Acupuncture
Placental expulsion time
Postpartum hemorrhage