Clinical trial NCT03825211: Continuous Versus Discontinuous Suture in the Perineals Lesions
Official title: Continuous Versus Discontinuous Suture in the Perineals Lesions Produced During Delivery in Primiparous: Maternal Results: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perineal Tear
Episiotomy Wound
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 134
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Analogical scale of pain
timeFrame: After delivery was done at two hours
measure: Numerical verbal scale for pain
timeFrame: After delivery was done at 24 hours
measure: Numerical verbal scale for pain
timeFrame: After delivery was done at 15 days
measure: Numerical verbal scale for pain
timeFrame: After delivery was done at three months.
Secondary outcomes:
measure: Questionnaire
timeFrame: After delivery was done 15 days
measure: Questionnaire
timeFrame: After delivery was done three months.
measure: Questionnaire on Women Sexual Function (WSF)
timeFrame: After delivery was done at three months.
Other outcomes:
Locations:
Study officials:
References:
citation: Martinez-Galiano JM, Arredondo-Lopez B, Hidalgo-Ruiz M, Narvaez-Traverso A, Lopez-Moron I, Delgado-Rodriguez M. Suture type used for perineal injury repair and sexual function: a randomised controlled trial. Sci Rep. 2020 Jun 29;10(1):10553. doi: 10.1038/s41598-020-67659-2.
citation: Martinez-Galiano JM, Arredondo-Lopez B, Molina-Garcia L, Camara-Jurado AM, Cocera-Ruiz E, Rodriguez-Delgado M. Continuous versus discontinuous suture in perineal injuries produced during delivery in primiparous women: a randomized controlled trial. BMC Pregnancy Childbirth. 2019 Dec 16;19(1):499. doi: 10.1186/s12884-019-2655-2.