Trial Outcomes & Findings for Influence of Acupuncture in the Placental Expulsion Time (NCT NCT02000752)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

120 participants

Primary outcome timeframe

Up to 30 minutes after the newborn delivery

Results posted on

2015-10-26

Participant Flow

Three midwives responsible for conducting the study were trained in the acupuncture technique during a 3 hour seminar. None of the 3 acupuncture-trained midwives were responsible for the management of labor, birth, or the third stage of labor. The midwife responsible for the birth measured the duration of the third stage of labor in minutes.

Inclusion criteria included: primiparous, aged between 20 and 35 years, at 37 to 42 weeks gestation with a low risk labor, receiving epidural analgesia. All criteria were chosen to homogenize the sample and minimize the number of excluded women.

Participant milestones

Participant milestones
Measure	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. Sham acupuncture: Sham point acupuncture	Acupuncture 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. Acupuncture
Overall Study STARTED	60	60
Overall Study COMPLETED	29	47
Overall Study NOT COMPLETED	31	13

Reasons for withdrawal

Reasons for withdrawal
Measure	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. Sham acupuncture: Sham point acupuncture	Acupuncture 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. Acupuncture
Overall Study Dystocic delivery	19	8
Overall Study Shift Changes	12	5

Baseline Characteristics

Influence of Acupuncture in the Placental Expulsion Time

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acupuncture n=47 Participants 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. Acupuncture	Sham Acupuncture n=29 Participants 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. Sham acupuncture: Sham point acupuncture	Total n=76 Participants Total of all reporting groups
Age, Continuous	30.39 years STANDARD_DEVIATION 4.95 • n=5 Participants	29.38 years STANDARD_DEVIATION 4.91 • n=7 Participants	30.00 years STANDARD_DEVIATION 4.96 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	29 Participants n=7 Participants	76 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Spain	47 participants n=5 Participants	29 participants n=7 Participants	76 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Sham Acupuncture n=29 Participants 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. Sham acupuncture: Sham point acupuncture	Acupuncture n=47 Participants 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. Acupuncture
The Principal Outcome of the Study is the Placental Expulsion Time.	15.21 minutes Interval 12.7 to 17.71	5.23 minutes Interval 4.69 to 5.82

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Sham Acupuncture n=29 Participants 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. Sham acupuncture: Sham point acupuncture	Acupuncture n=47 Participants 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. Acupuncture
Percentage of Participants Who Reported Experiencing Pain Related to Treatment	0 percentage	0 percentage

SECONDARY outcome

Timeframe: 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".

Outcome measures

Outcome measures
Measure	Sham Acupuncture n=29 Participants 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. Sham acupuncture: Sham point acupuncture	Acupuncture n=47 Participants 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. Acupuncture
Percentage of Mothers That Would Recommend the Technique to Any of Her Friends	100 percentage	97.87 percentage

SECONDARY outcome

Timeframe: 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"

Outcome measures

Outcome measures
Measure	Sham Acupuncture n=29 Participants 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. Sham acupuncture: Sham point acupuncture	Acupuncture n=47 Participants 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. Acupuncture
Degree of Ease With Which the Acupuncturist Administered the Treatment	93.97 units on a scale Standard Deviation 16.94	96.81 units on a scale Standard Deviation 8.34

Adverse Events

Sham Acupuncture

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Acupuncture

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Beatriz López Garrido (Midwife)

Fundación Investigación Biomédica Príncipe de Asturas

Phone: +34 678210013

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place