Clinical Trials Directory

Trials / Completed

CompletedNCT01626287

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
43 (actual)
Sponsor
Fraser Health · Academic / Other
Sex
Female
Age
19 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERFrozen perineal padFrozen ice pads will be provided as per participants' request
OTHERWarm water soaked Black Tea Bagswarm water soaked black tea bags will be provided to participants' as per their request

Timeline

Start date
2012-11-01
Primary completion
2013-05-01
Completion
2013-05-01
First posted
2012-06-22
Last updated
2015-05-25

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT01626287. Inclusion in this directory is not an endorsement.