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The effect of probiotic supplementation on episiotomy wound healing among primiparous women: a triple-blind randomized clinical trial.

  • 2023-05-05
  • BMC complementary medicine and therapies 23(1)

Study Design

Type
Randomized Controlled Trial (RCT)
Population
74 primiparous women with mediolateral episiotomy
Methods
Triple-blind RCT, Lactobacillus casei 431 1.5x10^9 CFU/capsule once daily for 14 days
Blinding
Triple-blind
Duration
14 days
Funding
Unclear

Background

Probiotics increase the defense power of immune system and accelerate the wound healing process by anti-inflammatory mechanisms at the wound site. The present study aimed at evaluating the effect of Lactobacillus casei oral supplementation on episiotomy wound healing among primiparous women.

Methods

This triple-blind randomized clinical trial was performed on 74 primiparous women delivered in Alzahra Hospital, Tabriz, Iran. Participants with mediolateral episiotomy (incision length equal to and less than 5 cm) were randomly assigned to the probiotic and placebo groups. The probiotic group received Lactobacillus casei 431 with 1.5 * 109 colony-forming unit /capsule once a day from the day after birth to 14 days. Wound healing as a primary outcome was measured by Redness, Edema, Ecchymosis, Discharge, Approximation and pain as a secondary outcome by the Visual Analogue Scale before discharge, 5 ± 1 and 15 ± 1 days after birth. The data were analyzed using independent t-test and repeated measures one way analysis of variance.

Results

The mean (standard deviation: SD) score of wound healing in the probiotic group altered from 4.91(1.86) before discharge to 1.55 (0.99) during 5 ± 1 days after birth and reached to 0.95 (0.27) during 15 ± 1 days after birth. Further, the mean (SD) score of wound healing in the placebo group altered from 4.62 (1.99) before discharge to 2.80 (1.20) during 5 ± 1 days after birth and reached to 1.45(0.71) during 15 ± 1 days after birth (adjusted mean difference: -0.50, confidence interval 95%: -0.96 to -0.05, P = 0.03).

Conclusion

Lactobacillus casei oral supplementation is effective in healing episiotomy wounds. It is suggested to evaluate the effect of topical use of Lactobacillus casei on episiotomy repair and pain in further studies.

Trial registration

Iranian Registry of Clinical Trials (IRCT): IRCT20170506033834N7. Date of registration: 11/08/2021.

Research Insights

  • Lactobacillus paracasei 431→Improved Wound Healing

    The mean (SD) score of wound healing in the probiotic group altered from 4.91(1.86) before discharge to 1.55 (0.99) during 5±1 days after birth and reached to 0.95 (0.27) during 15±1 days after birth. Further, the mean (SD) score of wound healing in the placebo group altered from 4.62 (1.99) before discharge to 2.80 (1.20) during 5±1 days after birth and reached to 1.45(0.71) during 15±1 days after birth (adjusted mean difference: -0.50, confidence interval 95%: -0.96 to -0.05, P=0.03).

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    1.5 * 10^9 colony-forming unit /capsule once a day
  • Lactobacillus paracasei 431→Reduced Pain

    pain as a secondary outcome by the Visual Analogue Scale before discharge, 5±1 and 15±1 days after birth.

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    1.5 * 10^9 colony-forming unit /capsule once a day
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