Tissue adhesive to repair first-degree perineal tear: a pilot randomized controlled trial

Purpose of Investigation: This pilot study proposes to verify the feasibility of conducting a randomized controlled trial (RCT) on the use of Epiglu tissue adhesive to repair first-degree tear. Materials and Methods: A pilot RCT was conducted in a birth center in Sao Paulo, Brazil. The sample consisted of 20 women with first-degree tear. These women were randomly assigned to the experimental group (EG=10) - perineal tear repair with Epiglu or the control group (CG=10) - perineal tear repair with absorbable synthetic thread. The measured outcomes were perineal pain, perineal healing, women's satisfaction, and professional's time spent repairing the perineum. Results: The intensity of perineal pain was significantly lower among women in the EG than that in the CG in all stages of the study (EG range: 2.0-0.2; CG range: 2.5-0.6). Additionally, perineal healing showed significantly better REEDA scores among women in the EG than those in the CG in all stages (EG range: 0.6-0.0; CG range: 1.8-0.7). Women's satisfaction was significantly higher in the EG (100% were satisfied or very satisfied) than that in the CG (10% to 20% of them were dissatisfied or very dissatisfied). The mean time spent to repair the perineum was five minutes in the EG and 21 minutes in the CG (p < 0.001). Conclusion: This study shows that it is feasible to undertake an RCT on the use of the tissue adhesive Epiglu for first-degree perineal tear repair during normal birth.