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

NCT01626287 | Completed DMC

• 1 other identifier: FHREB 2012-044
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Perineal Pain

Keywords

perineal; postpartum; pain; treatment; ice and black tea; maternal satisfaction

Outcome Measures

Primary Outcomes (1)

• use of analgesia during hospitalization

  24 hours post partum

Study Arms (2)

Black tea bag

EXPERIMENTAL

Other: Warm water soaked Black Tea Bags

ice packs

ACTIVE COMPARATOR

20 randomly chosen participants will be given frozen ice packs for perineal pain relief

Other: Frozen perineal pad

Interventions

Frozen perineal pad OTHER

Frozen ice pads will be provided as per participants' request

ice packs

Warm water soaked Black Tea Bags OTHER

warm water soaked black tea bags will be provided to participants' as per their request

Black tea bag

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fraser Health: lead

Study Sites (1)

Abbotsford Regional Hospital and Cancer Centre

Abbotsford, British Columbia, Canada

Location

Related Publications (1)

• East CE, Dorward ED, Whale RE, Liu J. Local cooling for relieving pain from perineal trauma sustained during childbirth. Cochrane Database Syst Rev. 2020 Oct 9;10(10):CD006304. doi: 10.1002/14651858.CD006304.pub4.

  PMID: 33034900 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Karmjit Kaur Sandhu, MScN

  Fraser Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2012
• First Posted: June 22, 2012
• Study Start: November 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 25, 2015

Record last verified: 2013-10

Locations

CA (1)