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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date August 2019
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
lidocaine-prilocaine cream
topical cream
meloxicam rectal suppository
suppository

Locations

Country Name City State
Egypt Assiut Faculty of Medicine Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

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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