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Clinical Trials/NCT01626287
NCT01626287
Completed
Not Applicable

Reduction of Perineal Pain After Vaginal Birth With Black Tea: Pilot Randomized Study

Fraser Health1 site in 1 country43 target enrollmentNovember 2012
ConditionsPerineal Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Perineal Pain
Sponsor
Fraser Health
Enrollment
43
Locations
1
Primary Endpoint
use of analgesia during hospitalization
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

Perineal trauma is common during vaginal birth. The discomfort this causes can interfere with a woman's recovery and early motherhood.Mothers are offered a standard treatment after childbirth, water soaked frozen peri pads (ice packs), to alleviate the discomfort. However, a Cochrane review questions the efficacy of ice packs treatment. An alternative treatment that may be more comfortable and effective for women is warm water soaked black tea bags. Medicinal use of black tea bags has been based on their astringent (shrinking or constricting) properties and have been used for various medical applications.

The investigators will conduct a pilot randomized controlled trial (RCT) of 40 pregnant mothers randomized to either intervention group (tea bags; n=20) or control group (ice packs; n=20). The goal of this pilot is to test the feasibility of a larger RCT by assessing recruitment, testing the protocol, and evaluating a proposed primary outcome objective of analgesic use during hospitalization as an indicator of pain. The investigators expect this pilot study to demonstrate feasibility for a large scale RCT to formally evaluate the efficacy of black tea bags to reduce perineal pain in this patient population.

Registry
clinicaltrials.gov
Start Date
November 2012
End Date
May 2013
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Fraser Health
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Primiparous women (delivering their first baby) over the age of 19 who have delivered vaginally at Abbotsford Regional Hospital and Cancer Centre

Exclusion Criteria

  • multiparity (women who have delivered vaginally more than once), VBAC (Vaginal Birth after Cesarean Section), active sexually transmitted infection lesions, vulvar varicosities, third and forth degree perineal tear, hematoma, retained placenta/products, substance abuse, and other medical conditions requiring frequent analgesia

Outcomes

Primary Outcomes

use of analgesia during hospitalization

Time Frame: 24 hours post partum

Study Sites (1)

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