Postpartum Women Clinical Trial
Official title:
Influence of Acupuncture in the Postpartum Blood Loss
In this study, a single blind randomized trial with third party evaluation is carried out in
order to compare the postpartum blood loss when Ren Mai 6 point is stimulated and when this
point is not stimulated.
Investigators focus on measuring the volume of postpartum blood during the third stage of
labor and during the first two hours after birth. A significant reduction in the volume of
bleeding would imply a reduction in the rate of postpartum hemorrhage (PPH) (more than 500
ml) and the rate of severe PPH (more than 1000 ml).
The principal outcome of the study is the volume of postpartum blood, this volume is
measured by the midwife who is responsible of the birth. Collection of lost blood is
initiated immediately after birth of the baby by passing a blood collection drape under the
woman's buttocks.
The secondary outcomes are the influence of acupuncture in the placental expulsion time, and
the influence of the predictor variables in the bleeding volume and in the placental
expulsion time: primiparity or multiparity, number of gestation including abortions, doses
of oxytocin during labor, maternal age, maternal weight in the beginning of the gestation,
maternal ponderal gain during pregnancy, date of the last blood test during pregnancy and
value of hemoglobin and hematocrit, spontaneous labor or induction by means of oxytocin or
prostaglandins, spontaneous or artificial rupture of membranes, first stage of labor
duration, second stage of labor duration, hours since rupture of membranes, hours since
epidural analgesia, volume of serotherapy during labor, and newborn weight. Possible
puerperal complications or security problems, the degree of Satisfaction of the Mother and
the degree of ease with which the acupuncturist administered the treatment are also
secondary outcomes.
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 pregnant women who were in labor
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 objective is to let
pregnant women know about the study before their labor 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 pregnant women from
18 to 40 years old, with eutectic delivery, gestation between 37 and 42 weeks, labors with
epidural analgesia.
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.
Regarding to the selection of patients, a randomization scheme will be performed using an
envelope based method. The researches will have opaque envelopes with a number outside, this
number being the code of the patient in the study. After the approval of the pregnant woman
and informed consent, the acupuncturist opens the envelop which will indicate the treatment
to follow, either control or intervention group. So, investigators guarantee randomization,
blindness and unpredictable selection of the sample.
In the labor ward, after delivery, the baby is placed on the abdomen of the puerperal mother
to facilitate maternal link. Collection of lost blood is initiated immediately after birth
of the baby by passing a blood collection bag under the woman's buttocks. The birth
attendant clamps the umbilical cord at first minute after birth and the acupuncturist
midwife performed the acupuncture procedure depending on the group assigned.
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. In the control group the puncture of the Ren Mai 6 is not performed. In
both cases, the needle is covered with a opaque plastic cup and the cup is set with adhesive
tape, guaranteeing that both the midwife responsible of the birth and the puerperal woman do
not know if the Ren Mai 6 acupuncture point has been punctured or not.
Afterwards, the midwife responsible of the birth expects to note the signs of placental
separation such as a gush of blood, uterine contraction, lengthening of the umbilical cord,
and visualization of the placenta in the vagina, and then encourage the woman to cough of
push. When the placental has been expelled, the midwife pays attention to the time passed
from the delivery to the placental expulsion, and she changes the collected bleeding drape
for another one if the puerperal women has to be sutured. Finally, a nappy is settled to the
puerperal woman until the first two hours after birth. This procedure is routinely used at
this hospital.
The midwife responsible of the birth weights one or both blood collection drapes, gauzes
used and nappy, and registers the data in a specific record. Taking into account the total
weight and the amount of material used, the volume of blood loss is estimated.
A survey will be fulfilled by the acupuncturist no more than 2 hours after the intervention.
In this survey, the midwife takes notes on the level of ease with which the technique was
performed with four possible answers (high, moderate, medium and low ease level).
Furthermore, the acupuncturist will ask to the puerperal woman if she would recommend this
technique to any of her friends with two possibles answers (yes or not).
The placental expulsion time will be measured after the childbirth is occurred. The weight
of the blood collected drapes, gauzes and nappy is registered in the first two hours after
birth, so too, the satisfaction of professionals and participants is noted in this time.
After this period of time, the puerperal woman is moved to the obstetrics plant which is out
of the labor room. Participants will be followed-up during the hospital stay, an expected
average of 2 days. The physician in charge of evaluation of the welfare of the puerperal
woman will annotate the existence or not of complications during the hospital stay in the
medical record of the woman, as it is routinely done at hospital.
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 assuring
confidentiality and freedom to withdraw from the study at any time.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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