MedTrace Logo

Influence of Acupuncture in the Postpartum Blood Loss

NCT02539121 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2015-09-02

No results posted yet for this study

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

Interventions

DEVICE

Acupuncture

Acupuncture needles

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Beatriz Lopez Garrido, Midwife · Hospital Universitario Principe de Asturias

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2017-09-30
Completion
2017-12-31

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02539121 on ClinicalTrials.gov