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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01626287
First Posted: June 22, 2012
Last Update Posted: May 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Fraser Health
  Purpose

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.


Condition Intervention
Perineal Pain Other: Frozen perineal pad Other: Warm water soaked Black Tea Bags

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)

Resource links provided by NLM:


Further study details as provided by Fraser Health:

Primary Outcome Measures:
  • use of analgesia during hospitalization [ Time Frame: 24 hours post partum ]

Enrollment: 43
Study Start Date: November 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Black tea bag Other: Warm water soaked Black Tea Bags
warm water soaked black tea bags will be provided to participants' as per their request
Active Comparator: ice packs
20 randomly chosen participants will be given frozen ice packs for perineal pain relief
Other: Frozen perineal pad
Frozen ice pads will be provided as per participants' request

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01626287


Locations
Canada, British Columbia
Abbotsford Regional Hospital and Cancer Centre
Abbotsford, British Columbia, Canada
Sponsors and Collaborators
Fraser Health
Investigators
Principal Investigator: Karmjit Kaur Sandhu, MScN Fraser Health Authority
  More Information

Responsible Party: Fraser Health
ClinicalTrials.gov Identifier: NCT01626287     History of Changes
Other Study ID Numbers: FHREB 2012-044
First Submitted: June 20, 2012
First Posted: June 22, 2012
Last Update Posted: May 25, 2015
Last Verified: October 2013

Keywords provided by Fraser Health:
perineal
postpartum
pain
treatment
ice and black tea
maternal satisfaction