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

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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Perineal Pain Other: Frozen perineal pad Other: Warm water soaked Black Tea Bags Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Study Start Date : November 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


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

Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
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
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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
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Canada, British Columbia
Abbotsford Regional Hospital and Cancer Centre
Abbotsford, British Columbia, Canada
Sponsors and Collaborators
Fraser Health
Investigators
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Principal Investigator: Karmjit Kaur Sandhu, MScN Fraser Health Authority
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Fraser Health
ClinicalTrials.gov Identifier: NCT01626287    
Other Study ID Numbers: FHREB 2012-044
First Posted: June 22, 2012    Key Record Dates
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