Ignite Creation Date:
2024-05-06 @ 2:15 AM
Last Modification Date:
2024-10-26 @ 11:15 AM
Study NCT ID:
NCT02000752
Status:
COMPLETED
Last Update Posted:
2015-10-26
First Post:
2013-11-20
Brief Title:
Influence of Acupuncture in the Placental Expulsion Time
Sponsor:
Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias
Organization:
Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias
Study Overview
Official Title:
Influence of Acupuncture in the Placental Expulsion Time
Status:
COMPLETED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 PrĂncipe 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 pregnancys 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 03d from the umbilicus being d the distance from the umbilicus to the upper part of the pubic symphysis A sterilized steel needle of 025x40 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 025x40 mm steel needle The control point is located at the same horizontal level than the Ren Mai 6 point but at 06d to the left of the anterior midline of the mother In this case the sterilized steel needle of 025x25 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 151999 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
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 03d from the umbilicus being d the distance from the umbilicus to the upper part of the pubic symphysis A sterilized steel needle of 025x40 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 025x40 mm steel needle The control point is located at the same horizontal level than the Ren Mai 6 point but at 06d to the left of the anterior midline of the mother In this case the sterilized steel needle of 025x25 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 151999 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None