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

Determining the effect of probiotic supplement on wound healing and postpartum depression in primiparous mothers

A triple-blind randomized controlled clinical trial with two arm parallel group, phase 3, will be conducted on 74 primiparous women. Eligible mothers will be assigned into groups of probiotic capsules and placebo, by random blocking with the block sizes of four and six, using RAS software with a ratio of 1: 1. The assignment type will put in opaque envelopes, based on the allocation sequence. A person uninvolved in the sampling process prepared the envelopes.

Sampling will perform on primiparous women who have given birth in Al-Zahra center in Tabriz. Participants will randomly assign in two groups. Both groups will receive routine education and postpartum care. Pain of episiotomy will assess by the VAS and for wound healing by the REEDA scale, before discharge, 5±1 and 15±1 days after birth. The Edinburgh Depression Scale will be completed by participants during 15±1, and 21±1 days after birth.

Inclusion Criteria: Primiparous women Body mass index less than 30 Exclusion Criteria: Episiotomy size of more than 5 cm History of previous depression Women with Immune deficiency disorder or anemia

The intervention group includes primiparous mothers with episiotomy who receive 500 mg of probiotic capsules containing Lactobacillus casei 431 with 1.5* 10 9 cfu/ml once a day after lunch, from day after birth for three weeks. The comparison group includes primiparous mothers with episiotomy who will receive placebo once a day for three weeks. Placebo will be the same as probiotic capsule in shape, color, odor, and dose.

Pain and wound healing of episiotomy, before discharge, 5±1 and 15±1 days after birth Postpartum Depression, 15±1, and 21±1 days after birth

Primiparous mothers with mediolateral episiotomy (incision length equal to and less than 5 cm) and eligible to participate in the study will assign to probiotic supplement and placebo groups by random blocking method with four and six block sizes using RAS software with allocation ratio 1: 1 . The allocation type will be written on paper and numbered in a series of opaque envelopes (Allocation Concealment). The envelopes will be opened sequentially by the person not involved in the sampling.

Participants, researcher and data safety and monitoring committee will be blinded at the present study. Placebo will be the same as probiotic capsule in shape, color, odor, and dose.

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