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Clinical and Experimental Obstetrics & Gynecology  2020, Vol. 47 Issue (2): 228-233    DOI: 10.31083/j.ceog.2020.02.5131
Original Research Previous articles | Next articles
Tissue adhesive to repair first-degree perineal tear: a pilot randomized controlled trial
T. Trevisan Teixeira1, *(), A. de S. Caroci2, W. Sousa Brunelli3, M. L. Riesco4
1School of Nursing, University of São Paulo. Midwife in clinical practice at Casa Angela Birth Center, Brazil
2School of Arts, Sciences and Humanities, University of São Paulo, Brazil
3School of Nursing, University of São Paulo, Brazil
4School of Nursing, University of São Paulo, Brazil
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Abstract  

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 S?o 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.

Key words:  Natural childbirth      Perineum      Lacerations      Tissue adhesives      Cyanoacrylates      Wound healing     
Published:  15 April 2020     
*Corresponding Author(s):  T. Trevisan Teixeira     E-mail:  thaistteixeira@gmail.com

Cite this article: 

T. Trevisan Teixeira, A. de S. Caroci, W. Sousa Brunelli, M. L. Riesco. Tissue adhesive to repair first-degree perineal tear: a pilot randomized controlled trial. Clinical and Experimental Obstetrics & Gynecology, 2020, 47(2): 228-233.

URL: 

https://ceog.imrpress.com/EN/10.31083/j.ceog.2020.02.5131     OR     https://ceog.imrpress.com/EN/Y2020/V47/I2/228

Figure 1.  — Participant flowchart.

Table 1  — Women’s characteristics.
Characteristic EG CG Total P Value a
n=10 100% n=10 100% n=20 100%
Skin colour
Brown 5 50 5 50 10 50 1.000
White 4 40 4 40 8 40
Black 1 10 1 10 2 10
Education level
Incomplete elementary school 0 0 1 10 1 5 0.650
Elementary school 5 50 6 60 11 55
Secondary school 5 50 3 30 8 40
Occupation
Homemaker 7 70 10 100 17 85 0.211
Employed 3 30 - - 3 15
Marital status
Living with a partner 8 80 9 90 17 85 1.000
Not living with a partner 2 20 1 10 3 15
Nutritional status
Underweight 2 20 4 40 6 30 0.700
Adequate 5 50 5 50 10 50
Overweight 1 10 - - 1 5
Obese 2 20 1 10 3 15
Previous vaginal delivery
No 6 60 7 70 13 65 1.000
Yes 4 40 3 40 7 35
Previous perineal tears sutured
No 9 90 7 70 16 80 0.582
Yes 1 10 3 30 4 20
Intrapartum antibiotic
No 9 90 9 90 18 90 1.000
Yes 1 10 1 10 2 10
Table 2  — Women’s and newborns’ characteristics.
Characteristic Group N Mean SD Min Max P-value a
Age (years) EG 10 26.6 7.3 17 39 0.158
CG 10 21.7 5.7 16 21
Gestational age (weeks) EG 10 38.9 1.3 37 41 0.710
CG 10 38.8 0.6 38 40
BMI EG 10 27.2 5.2 20 35 0.406
CG 10 25.5 4.8 19 35
Time between hospitalization and delivery (hours) EG 10 6.2 4.4 0.4 15.0 0.880
CG 10 6.2 5.0 0.7 17.6
Time of amniotic membranes rupture (hours) EG 10 6.4 6.4 0.5 16.7 0.112
CG 10 3.9 5.2 0.2 13.0
Newborn weight (grams) EG 10 3250.5 324.6 2810 3760 0.226
CG 10 3020.0 330.8 2545 3460
Head circumference (cm) EG 10 34.6 1.0 33 36 0.117
CG 10 33.7 1.3 31 35
Table 3  — Pain (VNS), healing (REEDA), and women’s satisfaction.
Step EG CG Group Step Group x Step
n Mean (SD) n Mean (SD)
Pain (VNS) P-value a
1 10 0.4 (1.3) 10 2.4 (1.9) 0.036 0.013 0.226
2 10 2.0 (2.3) 10 2.5 (2.7)
3 10 0.8 (0.9) 10 2.5 (2.8)
4 10 0.2 (0.6) 9 0.6 (1.1)
Healing (REEDA) P-value a
2 10 0.5 (1.0) 10 1.8 (1.4) 0.018 0.049 0.456
3 10 0.6 (0.8) 10 1.2 (1.5)
4 10 0.0 9 0.7 (1.0)
Satisfaction (Likert-type) P-Value b
VD D S VS VD D S VS
n (%) n (%) N (%) n (%) n (%) n (%) n (%) n (%)
1 10 - - 4 6 10 - 1 6 3 < 0.001 0.009 0.153
- - (40) (60) - (10) (60) (30)
2 10 - - 7 3 10 1 2 6 1
- - (70) (30) (10) (20) (60) (10)
3 10 - - 3 7 10 - 1 7 2
- - (30) (70) - (10) (70) (20)
4 10 - - - 10 9 1 1 5 2
- - - (100) (11.1) (11.1) (55.6) (22.2)
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