Postpartum Clinical Trial
Official title:
Effect of Topical Lidocaine-prilocaine Cream Versus Rectal Meloxicam Suppository on Relief of Post-episiotomy Pain: A Randomized Clinical Trial
NCT number | NCT03146000 |
Other study ID # | PEP |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | May 1, 2017 |
Est. completion date | October 1, 2018 |
Verified date | August 2019 |
Source | Assiut University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Postpartum perineal pain is a very common complaint. It can have negative consequences for
mother and child including disability in daily functioning for the mother; for example, it
can interfere in taking care of her infant and in breastfeeding. Early pain management is
thus relevant to provide relief and prevent chronicity.
Perineal pain is particularly common following childbirth. Macarthur 2004, in a prospective
cohort study involving 447 women in Canada, reported an incidence of perineal pain, in the
first day after birth, of 75% in women with an intact perineum
Status | Completed |
Enrollment | 190 |
Est. completion date | October 1, 2018 |
Est. primary completion date | August 31, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: 1. Primiparas 2. Normal vaginal delivery 3. Mediolateral episiotomy 4. Ability to understand and the willingness to sign a written informed consent Exclusion Criteria: 1. Patients who had postpartum hemorrhage 2. Patients who had manual removal of the placenta 3. Patients with contraindications to non steroidal drugs 4. Patients with a multiple perineal lacerations |
Country | Name | City | State |
---|---|---|---|
Egypt | Assiut Faculty of Medicine | Assiut |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The mean difference of visual analog scale after delivery | the scale is graded from 0 to 10 | immediately |
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