Influence of Acupuncture in the Placental Expulsion Time
Condition: Placental Expulsion Time
Study type: Interventional

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.
    

Intervention name(s): Acupuncture; Sham acupuncture
Intervention type(s): Device; Device
Intervention description(s): Sham point acupuncture
Other intervention name(s): acupuncture needles; acupuncture needles
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Labor; Acupuncture; Placental expulsion time; Postpartum hemorrhage