Women After Delivery With Perineal Pain
Conditions
Brief summary
Perineal pain after delivery is common and is caused by local bruising or episiotomy. The pain may last for several days or months. Thus, several analgesic methods are offered. Topical magnesium sulfate 33% solution is a common treatment for perineal pain, wound treatment and alleviation of swelling. Yet, the efficacy of this treatment was not tested sufficiently in a clinical trials. In the present study we will compare the efficacy of topical magnesium sulfate versus cold water for perineal pain and improved perineal healing after delivery. Women after vaginal delivery (spontaneous or operative) with pain score of 3 in 0-10 numeric rating scale (NRS) will randomly be allocated to receive either pad with cold magnesium sulfate 33% solution or cold water. Pain score and healing parameters will be assessed at baseline, after one day of treatment and after two days of treatment.
Interventions
DRUGMagnesium sulfate 33% solution
Topical pads with cold magnesium sulfate 33% solution will be given 5 times/day for 15 minutes
OTHERCold water
Topical pads with cold water will be given 5 times/day for 15 minutes
Sponsors
The Baruch Padeh Medical Center, Poriya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Woman after spontaneous or operative vaginal delivery * Perineal pain score of at least 2 NRS
Exclusion criteria
* Women after cesarean delivery * Refuse to participate * Under 18 years of age * Magnesium sulfate treatment not related to the study * Contraindication for magnesium sulfate treatment * Workers of the local obstetric department
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of women with perineal pain score< 3 NRS at the day after treatment initiation | 24 hours post enrollment |
| Perineal pain intensity according to NRS scale at the day after treatment initiation | 24 hours post enrollment |
Secondary
| Measure | Time frame |
|---|---|
| Degree of perineal healing using the REEDA scale | 2 days |
| Perineal pain intensity according to NRS scale two days after treatment initiation | 2 days (if still in hospital) |
| Rate of women with improvement in hemorrhoids characteristics in women with hemorrhoids | 2 days |
Countries
Israel
Contacts
Primary ContactEnav Yefet, MD/PhD
Outcome results
None listed