Influence of Acupuncture in the Placental Expulsion Time

NCT02000752 | Completed Results

• 1 other identifier: PI 36/2010
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Placental Expulsion Time

Keywords

Labor; Acupuncture; Placental expulsion time; Postpartum hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 30 minutes after the newborn delivery

Secondary Outcomes (3)

• 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

Study Arms (2)

Acupuncture

EXPERIMENTAL

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.

Device: Acupuncture

Sham acupuncture

SHAM COMPARATOR

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.

Device: Sham acupuncture

Interventions

Acupuncture DEVICE

Also known as: acupuncture needles

Acupuncture

Sham acupuncture DEVICE

Sham point acupuncture

Also known as: acupuncture needles

Sham acupuncture

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Primiparous women between 20 and 35 years old
• Within 37 and 42 weeks of gestation
• Low obstetric risk labor
• With epidural analgesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias: lead

Study Sites (1)

Hospital Universitario Principe de Asturias

Alcalá de Henares, Madrid, 28805, Spain

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Results Point of Contact

• Title: Beatriz López Garrido (Midwife)
• Organization: Fundación Investigación Biomédica Príncipe de Asturas

bealopega@gmail.com

+34 678210013

Study Officials

• Beatriz Lopez Garrido, Midwife

  Hospital Universitario Principe de Asturias

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2013
• First Posted: December 4, 2013
• Study Start: April 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: October 26, 2015
• Results First Posted: October 26, 2015

Record last verified: 2015-09

Locations

ES (1)