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
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
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
- 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.
- 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).
- 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".
- 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"
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
|Hospital Universitario Principe de Asturias|
|Alcala de Henares, Madrid, Spain, 28805|
|Principal Investigator:||Beatriz Lopez Garrido, Midwife||Hospital Universitario Principe de Asturias|