Influence of Acupuncture in the Postpartum Blood Loss

NCT02539121 | Unknown

• 1 other identifier: RenMai6
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postpartum Women

Keywords

Labor; Acupuncture; Postpartum hemorrhage; Placental expulsion time; Postpartum blood loss

Outcome Measures

Primary Outcomes (1)

• Postpartum blood loss

  This volume is measured by the midwife responsible of the birth who does not know if the point is punctured or not, thus guaranteeing the third party evaluation.

  First two hours after birth

Secondary Outcomes (4)

• Placental Expulsion Time

  First two hours after birth

• Number of participants with puerperal complications

  48 hours after birth

• Degree of Satisfaction of the Mother

  Two hours after labor

• Degree of ease with which the technique was administered

  Two hours after labor

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. After that, the needle is covered with a opaque plastic cup and the cup is fixed with the adhesive tape.

Device: Acupuncture

Control

PLACEBO COMPARATOR

In the control group the puncture of the Ren Mai 6 is not performed, the acupuncturist disinfects the abdominal area with antiseptic and put the needle in the area of Ren Mai 6 without puncturing, after that, the needle is fixed but not punctured, and it is covered with a opaque plastic cup fixed with adhesive tape, guaranteeing that neither the mother nor the midwife responsible of measuring the variables can identify the assigned group.

Interventions

Acupuncture DEVICE

Acupuncture needles

Acupuncture

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women from 18 to 40 years old
• Within 37 and 42 gestation weeks
• Low obstetric risk labor
• With epidural analgesia

You may not qualify if:

• Pregnant woman with metal allergy
• Patients with anticoagulant treatment
• Dystocic labor
• Uterine overdistension
• Precipitous (less than 2 hours) or prolonged ( more than 11 hours) first stage of labor
• Pregnant woman with coagulation disorders
• Alterations in the placental insertion
• Pregnant woman with curettage
• Woman with previous uterine surgery or myomatosis
• Use of uterine relaxants during labor
• Patients who do not understand Spanish or are not be able to understand the procedure of the study or to sign 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

Study Officials

• Beatriz Lopez Garrido, Midwife

  Hospital Universitario Principe de Asturias

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beatriz Lopez Garrido, Midwife

CONTACT

+34 678 21 00 13; bealopega@gmail.com

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: August 26, 2015
• First Posted: September 2, 2015
• Study Start: October 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: September 2, 2015

Record last verified: 2015-08

Locations

ES (1)