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

F

Fraser Health

Status

Completed

Conditions

Perineal Pain

Treatments

Other: Warm water soaked Black Tea Bags
Other: Frozen perineal pad

Study type

Interventional

Funder types

Other

Identifiers

NCT01626287
FHREB 2012-044

Details and patient eligibility

About

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.

Enrollment

43 patients

Sex

Female

Ages

19+ years old

Volunteers

No Healthy Volunteers

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

Trial design

43 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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