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

Perineal Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01626287
• Other study ID #: FHREB 2012-044
• Status: Completed
• Phase: N/A
• First received: June 20, 2012
• Last updated: May 22, 2015
• Start date: November 2012
• Est. completion date: May 2013

Study information

• Verified date: October 2013
• Source: Fraser Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Perineal Pain

Intervention

Other:
• Frozen perineal pad
Frozen ice pads will be provided as per participants' request
• Warm water soaked Black Tea Bags
warm water soaked black tea bags will be provided to participants' as per their request

Locations

Country	Name	City	State
Canada	Abbotsford Regional Hospital and Cancer Centre	Abbotsford	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Fraser Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	use of analgesia during hospitalization		24 hours post partum	No