Surgical adhesive glue to repair first-degree perineal tears in vaginal birth: A randomised controlled clinical trial.

BACKGROUND

Perineal tears in vaginal birth are highly prevalent and may be related to physical and psychological trauma. Surgical glues are an alternative repair method to avoid the pain that may be caused by perineal repairs with sutures.

OBJECTIVE

To evaluate the effectiveness of surgical adhesive glue in reducing perineal pain when compared to sutures in first-degree perineal tears resulting from vaginal birth.

DESIGN

Open-label parallel-group randomised controlled trial.

SETTING

An alongside birth centre in Sao Paulo, Brazil.

PARTICIPANTS

84 intrapartum women with first-degree perineal tears needing repair.

METHODS

In the experimental group ( = 42), the perineal tears were repaired with Epiglu® surgical glue (ethyl-2-cyanoacrylate); in the control group ( = 42), the tears were repaired with Vicryl Rapide® (polyglactin 910) sutures. The primary outcome was the intensity of perineal pain after birth measured by a numeric pain rating scale ranging from 0 to 10 points. The secondary outcomes were healing, measured by the "Redness, Oedema, Ecchymosis, Discharge, and Approximation" scale; women's satisfaction with the perineal repair, measured by a visual analogue scale; and the time necessary to complete the repair. Data were collected during postpartum hospitalisation and 10-20 days after discharge, from December 2020 to May 2021. Data were analysed using bivariate analysis and linear models by intention-to-treat.

RESULTS

36-48 h after birth, the mean of perineal pain was 0.2 (95% Confidence Interval [CI] 0.1-0.8) in the experimental group and 0.9 (95% CI 0.5-1.5) in the control group; the perineal healing score was 0.7 (95% CI 0.4-1.2) and 0.8 (95% CI 0.5-1.2), in the experimental and control groups, respectively; satisfaction was higher among women in the experimental group (88.1% versus 83.3% in the control group). After discharge, the mean of perineal pain was 0.1 (95% CI 0.0-0.5) in the experimental group and 1.4 (95% CI 0.8-2.2) in the control group; the perineal healing score was 0.0 (95% CI 0) and 1.0 (95% CI 0.7-1.3) in the experimental and control groups, respectively. Satisfaction was higher in the experimental group (94.9% versus 75.0%). The longitudinal analysis showed statistically significant differences between the groups regarding perineal pain and women's satisfaction. The average time necessary for perineal repair was 6.0 (95% CI 4.7-8.7) minutes in the experimental group and 9.7 (95% CI 8.3-11.5) in the control group ( < 0.001).

CONCLUSIONS

Surgical glue resulted in less perineal pain, faster repair, and greater satisfaction than perineal sutures after birth. The healing process was similar in both cases.

TWEETABLE ABSTRACT

Surgical glue was less painful and promoted greater satisfaction after birth compared to sutures in women with first-degree perineal tears.

REGISTRATION

Registered on The Brazilian Clinical Trials Registry number RBR-52y5tq (http://www.ensaiosclinicos.gov.br/rg/RBR-52y5tq/), on July 16, 2020. The first recruitment was on December 17, 2020.