Delivery; Injury Clinical Trial
Official title:
Radiofrequency Technic's Impact on Perineal Postpartum Pain
A study in the postpartum period reveals that among women who delivered vaginally and having
perineal lesions, between 95 and 100% of them suffer from perineal pain (episiotomy, tears
from 1st to 4th degree) to 24 hours of vaginal delivery; and between 60 and 91% 7 days after
delivery.
Severe pain that is not taken into account can become chronic pain. It has physical and
psychological consequences. It is therefore essential to prevent these risks in young
mothers.
The main objective of this study is to assess the efficacy of radiofrequency treatment on
perineal pain postpartum, after a vaginal delivery, instrumented or not, in patients with
perineal lesions.
A double-blind randomized prospective single-center study will be conducted on patients
delivering at Marseille's north hospital.
Women who gave birth to the North hospital site, with perineal lesions (tears, episiotomy)
will be invited to enroll in the study.
Patients will be then randomized into two groups, one with radiofrequency treatment, the
other without treatment with radiofrequency.
The duration of inclusion is provided over 6 months. Each topic will be followed over a
period of 1 month. The total study duration is 7 months.
The expected results are a significant reduction in pain scores during the first days
postpartum in women with perineal alteration caused by a vaginal delivery instrumented or
not. Also an improvement in the quality of life of patients during the first days.
| Status | Recruiting |
| Enrollment | 62 |
| Est. completion date | December 31, 2018 |
| Est. primary completion date | April 1, 2018 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients who naturaly delivered with ou without instruments such as Suction cup, spatulas, forceps - Patients presenting perineal lesions Exclusion Criteria: - Patients who delivered through cesarean section |
| Country | Name | City | State |
|---|---|---|---|
| France | Assistance Publique Hôpitaux de Masreille | Marseille |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique Hopitaux De Marseille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pain score using analogical pain scale | Pain score will be assessed before and after the radiofrequencing cession | 30 minutes |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT05468658 -
The Effect of Feng Shui Delivery Room Design on Maternal and Infant Health
|
N/A |