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The effect of probiotic supplement on episiotomy wound healing and postpartum depression in primiparous mothers: a randomized clinical trial

The effect of probiotic supplement on episiotomy wound healing and postpartum depression in primiparous mothers: a randomized clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20170506033834N7
Enrollment
74
Registered
2021-08-11
Start date
2021-09-06
Completion date
Unknown
Last updated
2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Episiotomy wound healing. Condition 2: Postpartum depression. Condition 3: Episiotomy pain. Disruption of perineal obstetric wound Other depressive episodes Acute pain due to trauma

Interventions

Intervention 1: Intervention group will receive 500 mg oral probiotic capsule containing Lactobacillus casei (L. Casei 431), made in Danmark and produced by Zist Takhmir Co., with 1.5 * 10 9 cfu, onc

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Primiparous women Living in Tabriz alive and single fetus delivery Body mass index less than 30

Exclusion criteria

Exclusion criteria: women without episiotomy Women with a body mass index above 30 High-risk pregnancy and births Previous history of depression Indications of using antibiotic after birth

Design outcomes

Primary

MeasureTime frame
Wound healing score by REEDA scale. Timepoint: Before discharge, 5 ± 1 and 15 ± 1 days after birth. Method of measurement: REEDA (Redness, Edema, Ecchymosis,Discharge, Approximation).;Pain score of episiotomy. Timepoint: Before discharge, 5 ± 1 and 15 ± 1 days after birth. Method of measurement: VAS= Visual Analogue Scale.;Postpartum depression score by Edinburgh scale. Timepoint: 15± 1 and 21 ± 1 days after birth. Method of measurement: Edinburgh Postpartum Depression Scale.

Secondary

MeasureTime frame
Frequency of side effects. Timepoint: 5 ± 1 and 15 ± 1 days after birth. Method of measurement: Frequency (number and percentage) will be used to state side effects.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDerakhshan Abdollahpour

Tabriz University of Medical Sciences

mdabdolapour@gmail.com0444322759

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 9, 2026