Influence of Acupuncture in the Placental Expulsion Time
Influence of Acupuncture in the Placental Expulsion Time
Sponsors
Source
Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias
Oversight Info
Has Dmc
No
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.
Detailed Description
This study is designed as a single-blind randomized clinical trial with parallel design, and
third party evaluation at the Hospital Universitario Príncipe de Asturias in Alcalá de
Henares (Madrid, Spain). The study will be carry out with primiparous women who were in
labour at this hospital. Information sheets about the study will be distributed by the
different health care centers coordinated by the hospital. The midwives will give the
information sheets to pregnant women during the pregnancy's attendances. The aim is to let
pregnant women know about the study before their labour date in order to encourage them to
participate in it.
Pregnant women fulfilling all the inclusion criteria and none of the exclusion criteria will
be invited to participate in the experiment. These requirements includes primiparous women
from 20 to 35 years old, with 37 to 42 weeks of gestation, and with a low obstetric risk
labor with epidural analgesia. It is important to highlight that the midwife responsible for
the labor is different from the acupuncturist responsible for the treatment.
An envelope with 120 leaflets will be enabled, 60 with control group name and 60 with
intervention group name. After the approval of the pregnant woman, the acupuncturist will ask
a partner midwife, a doctor or a nursing assistant to randomly pick up one of the leaflets
from the aforementioned envelope, so pregnant woman will be assigned to a group. It is
important to highlight that both the midwife and the pregnant woman must not know about the
assigned group.
In the labor ward, after the childbirth, the baby is placed on the abdomen of the puerperal
mother to facilitate maternal link. Then, the umbilical cord is clamped by the midwife. After
all this process, that takes around a minute, the needle will be placed by the acupuncturist
in the position corresponding to the randomly assigned group.
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 will be inserted in this point at 15-30 mm, depending on the adipose
tissue of the woman.
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 will be
inserted 15 mm into the tissue.
After the needle is punctured by the acupuncturist, the midwife waits for the placental
expulsion, and pays attention on the time passed from the childbirth to the placental
expulsion. After that, the time is registered into the partogram by the midwife. The needle
will be then removed and the abdominal area completely sterilized by the acupuncturist.
A survey will be fulfilled by the midwife no more than 2 hours after the intervention. In
this survey, the midwife takes notes on the comfort with which the technique was performed
with four possible answers (high, moderate, medium and low comfort level). Furthermore, the
acupuncturist will ask to the puerperal woman about the pain felt with the technique with
four possible answers (painless, mild pain, moderate pain and high pain). The acupuncturist
will also ask to the puerperal woman if she would recommend this technique to any of her
friends with two possibles answers (yes or not).
Participants will be followed-up during the hospital stay, an expected average of 3 days. The
expulsion placental time will be measured in the first thirty minutes after the childbirth is
occurred. The satisfaction of professionals and participants, and the existence of pain
during the technique will be registered into the 2 hours after the childbirth and before the
puerperal woman is moved to the obstetrics plant which is out of the labor room. At last, the
physician will annotate the existence of puerperal complications during the hospital stay in
a specific sheet attached in the medical record of the woman. It will be done just before the
woman discharges from the hospital, approximately three days after the labor.
In the medical record, an incidence form will be attached to be fulfilled in case of adverse
events. So, the physician in charge of evaluating the welfare of the puerperal woman will
register any kind of complication if it would have appeared. In other case, the physician
will note the lack of complications.
Concerning the procedure and data collection, the acupuncturist will request permission to
midwife responsible of the mother for their collaboration in the study in the pre-labor room.
The acupuncturist will explain the study to the mother and her partner and will apply for her
voluntary participation being the informed consent offered then. All information will be
given when the pregnant woman is without pain of labor, preferably when the woman is under
the epidural analgesia effects.
All the study will be performed in conditions of respect for individual rights and ethical
principles affecting biomedical research involving human. Written informed consent will be
fulfilled by all participants.
In particular, the physical and mental integrity of women will be safeguarded, as well as
privacy and data protection in accordance to the spanish Organic Law 15/1999, of December 13,
Protection of Personal Data. All the participants will give their informed consent in
accordance with the Declaration of Helsinki (25) assuring confidentiality and freedom to
withdraw from the study at any time.
Overall Status
Completed
Start Date
2011-04-01
Completion Date
2013-03-01
Primary Completion Date
2013-03-01
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
The Principal Outcome of the Study is the Placental Expulsion Time. |
Up to 30 minutes after the newborn delivery |
Secondary Outcome
Measure |
Time Frame |
Percentage of Participants Who Reported Experiencing Pain Related to Treatment |
Measured into the 2 hours after the childbirth but before puerperal woman is moved to the obstetrics plant out of the labor room |
Percentage of Mothers That Would Recommend the Technique to Any of Her Friends |
Measured into the 2 hours after the childbirth but before puerperal woman is moved to the obstetrics plant out of the labor room |
Degree of Ease With Which the Acupuncturist Administered the Treatment |
Measured into the 2 hours after the childbirth but before puerperal woman is moved to the obstetrics plant out of the labor room |
Enrollment
120
Condition
Intervention
Intervention Type
Device
Intervention Name
Arm Group Label
Acupuncture
Other Name
acupuncture needles
Intervention Type
Device
Intervention Name
Description
Sham point acupuncture
Arm Group Label
Sham acupuncture
Other Name
acupuncture needles
Eligibility
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
Gender
Female
Minimum Age
20 Years
Maximum Age
35 Years
Healthy Volunteers
Accepts Healthy Volunteers
Overall Official
Last Name |
Role |
Affiliation |
Beatriz Lopez Garrido, Midwife |
Principal Investigator |
Hospital Universitario Principe de Asturias |
Location
Facility |
Hospital Universitario Principe de Asturias Alcala de Henares Madrid 28805 Spain |
Location Countries
Country
Spain
Verification Date
2015-09-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Number Of Arms
2
Arm Group
Arm Group Label
Acupuncture
Arm Group Type
Experimental
Description
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.
Arm Group Label
Sham acupuncture
Arm Group Type
Sham Comparator
Description
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.
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Single (Participant)
Study First Submitted
November 20, 2013
Study First Submitted Qc
November 27, 2013
Study First Posted
December 4, 2013
Last Update Submitted
September 25, 2015
Last Update Submitted Qc
September 25, 2015
Last Update Posted
October 26, 2015
Results First Submitted
July 4, 2015
Results First Submitted Qc
September 25, 2015
Results First Posted
October 26, 2015
ClinicalTrials.gov processed this data on December 09, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.