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

• ClinicalTrials.gov Identifier: NCT01626287
• Recruitment Status: Completed
• First Posted: June 22, 2012
• Last Update Posted: May 25, 2015
• Sponsor: Fraser Health
• Information provided by (Responsible Party): Fraser Health

Tracking Information

• First Submitted Date: June 20, 2012
• First Posted Date: June 22, 2012
• Last Update Posted Date: May 25, 2015
• Study Start Date: November 2012
• Actual Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 21, 2012): use of analgesia during hospitalization [ Time Frame: 24 hours post partum ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Reduction of Perineal Pain After Vaginal Birth With Black Tea: Pilot Randomized Study
• Official Title: Not Provided

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator)
• Condition: Perineal Pain

Intervention

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

Study Arms

• Experimental: Black tea bag
  Intervention: Other: Warm water soaked Black Tea Bags
• Active Comparator: ice packs
  20 randomly chosen participants will be given frozen ice packs for perineal pain relief
  Intervention: Other: Frozen perineal pad

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 28, 2013): 43
• Original Estimated Enrollment (submitted: June 21, 2012): 40
• Actual Study Completion Date: May 2013
• Actual Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 19 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT01626287
• Other Study ID Numbers: FHREB 2012-044
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Fraser Health
• Original Responsible Party: Same as current
• Current Study Sponsor: Fraser Health
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Karmjit Kaur Sandhu, MScN; Fraser Health Authority

• PRS Account: Fraser Health
• Verification Date: October 2013