Continuous Versus Discontinuous Suture in the Perineals Lesions

Perineal Tear Clinical Trial

Official title:

Continuous Versus Discontinuous Suture in the Perineals Lesions Produced During Delivery in Primiparous: Maternal Results: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03825211
• Other study ID #: Ujaen Sutura Lesiones
• Status: Completed
• Phase: N/A
• Start date: November 1, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2019
• Source: University of Jaén
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The hypothesis: Women who have a continuous suture have better health outcomes Two types of sutures were placed in the perineal lesion, using different techniques. Group A received continuous sutures and Group B had interrupted sutures placed. The women were followed-up as follows: Day of childbirth and in the postpartum period.

Description:

The hypothesis: Women who have a continuous suture have better health outcomes Two types of sutures were placed in the perineal lesion, using different techniques. Group A received continuous sutures and Group B had interrupted sutures placed. The women were allocated to a treatment group using a computer-generated random numbers table. The sequence was placed in individual opaque envelopes that were opened when a woman met the inclusion criteria.

The health personnel that carry out the sutures had taken a training course on continuous suture technique and had at least one year experience in this technique. Additionally, this person had a minimum of five years of experience in attending deliveries and therefore also in the suturing of perineal lesions. The sutures were placed by ten trained midwives. Around 5% of the midwives in Torrecardenas, 10% in the Hospital Complex of Jaen, 12% in Granada, and 20% of the midwives in Ubeda and Linares participated.

Data collection Data was collected on sociodemographic variables, type of perineal trauma (tear of second-degree or episiotomy), type of suture used, time spent placing suture, number of suture packets used, complications, analogical scale of pain, type of pain, need for analgesia, wound condition, care performed, urinary and/or fecal incontinence, start of sexual relations, start of physical activity and type of newborn feeding. It was also collected the start and type of delivery, medication during dilation, type of analgesia used, gestational week, duration of dilation, second stage labor and delivery, and data on the newborn.

Information was gathered by midwives which interviewed the women in the labor room, providing them with an informed consent form, and hiding the suture technique that was going to be used. The rest of the data were obtained from the clinical history, maternal record book and phone calls made for the follow-up. The women did not know at any point which suture technique had been used.

Follow-up

The women were followed-up as follows:

Day of childbirth: in the postpartum period, the midwife collected data on the type of delivery, need for epidural analgesia, duration of dilation, stage two of labor, delivery, type of perineal trauma, time used to place suture, number of suture packets, wound complications, newborn weight and the Apgar score at one minute and at five minutes. After the suture was placed, they assessed pain on the pain scale and assessed the wound.

Follow-up after delivery was done at two hours, 24 hours, 15 days and three months. Pain, need for analgesia, wound condition, sphincter incontinence and the start of sexual relations were assessed (15 days and three months).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: December 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >18 years

• Primiparous

• Singleton and eutocic delivery

• Second-degree perineal tear or an episiotomy as part of labor

• Newborn weight between 2500 g and 4000 g

Exclusion Criteria:

• Language barrier (to no speak spanish)

• Problems related to the pelvic floor prior to labor (prolapse, incontinence, vulva varices)

• Dyspareunia or sexual dysfunction

• Hemorrhoids perceived as uncomfortable or painful

Related Conditions & MeSH terms

• Episiotomy Wound
• Perineal Tear

Intervention

Procedure:
• Continuous suture in the perineals lesions
A continuous suture of the vagina, muscle and skin is performed continuously, without knotting or cutting the suture thread.
• Discontinuous suture in the perineals lesions
Suture the muscle independently of the vagina and independently of the skin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Jaén

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analogical scale of pain	It consists of a line horizontal 10 centimeters, at the ends of which are the extreme expressions of a symptom In the left is the absence or less intensity and in the right the greater intensity	After delivery was done at two hours
Primary	Numerical verbal scale for pain	Scale numbered 1-10, where 0 is the absence and 10 the highest intensity, the patient selects the number that best assesses the intensity of the symptom.	After delivery was done at 24 hours
Primary	Numerical verbal scale for pain	Scale numbered 1-10, where 0 is the absence and 10 the highest intensity, the patient selects the number that best assesses the intensity of the symptom.	After delivery was done at 15 days
Primary	Numerical verbal scale for pain	Scale numbered 1-10, where 0 is the absence and 10 the highest intensity, the patient selects the number that best assesses the intensity of the symptom.	After delivery was done at three months.
Secondary	Questionnaire	The woman was asked if she had involuntary urine losses.The possible answer is "yes" (she has incontinence) or "no" (she has no incontinence)	After delivery was done 15 days
Secondary	Questionnaire	The woman was asked if she had involuntary urine losses. The possible answer is "yes" (she has incontinence) or "no" (she has no incontinence)	After delivery was done three months.
Secondary	Questionnaire on Women Sexual Function (WSF)	This questionnaire has been validated in Spain. The instrument is composed of two types of domains: the evaluators of sexual activity, which are answered by a Likert scale of five values; and the descriptive ones, which have no quantitative value and help to know issues such as the frequency of sexual activity or the existence of sexual dysfunction in the respondent. It consists of 14 items, an alternative item and a question to open the questionnaire. To diagnose sexual dysfunction, only 6 questions are counted: Desire, Excitement, Lubrication, Orgasm, Problems with vaginal penetration, Anticipatory anxiety. Diagnostic results are categorized into: severe, moderate and no-disorder disorder. It does not establish degrees of dysfunctionality of sexual function, it is not shown in validation study if there is a cutoff point. The maximum score of this questionnaire is 100, which is interpreted as "without sexual dysfunction".	After delivery was done at three months.