N/A
N=120
Influence of Acupuncture in the Placental Expulsion Time
Placental Expulsion Time
Bottom Line
View on ClinicalTrials.gov: NCT02000752 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Oct 2015
Primary outcome: Primary: The Principal Outcome of the Study is the Placental Expulsion Time. — 15.21; 5.23 minutes — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Acupuncture (Device); Sham acupuncture (Device)
- Age
- Adult · 20+ yrs
- Sex
- Female
- Sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Principal Outcome of the Study is the Placental Expulsion Time. |
15.21; 5.23 | <0.001 sig |
| SECONDARY Percentage of Participants Who Reported Experiencing Pain Related to Treatment |
0; 0 | 1 |
| SECONDARY Percentage of Mothers That Would Recommend the Technique to Any of Her Friends |
100; 97.87 | 0.16 |
| SECONDARY Degree of Ease With Which the Acupuncturist Administered the Treatment |
93.97; 96.81 | 0.2 |
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.
Eligibility Criteria
Inclusion Criteria
- Primiparous women between 20 and 35 years old
- Within 37 and 42 weeks of gestation
- Low obstetric risk labor
- With epidural analgesia
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02000752). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.