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

Phase 3

• 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; O90.1; F32.8; G89.11

• Registration Number: IRCT20170506033834N7
• Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 74

Inclusion Criteria

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.