NCT03825211

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

1.6 years

First QC Date

January 25, 2019

Last Update Submit

January 30, 2019

Conditions

Perineal TearEpisiotomy Wound

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (3)

  • Questionnaire

    After delivery was done 15 days

  • Questionnaire

    After delivery was done three months.

  • Questionnaire on Women Sexual Function (WSF)

    After delivery was done at three months.

Study Arms (2)

Continuous suture

EXPERIMENTAL

All parts of the perineal lesion (vaginal mucosa , perineal muscle and skin) be sutured with the same suture thread. A single suture for perineal lesion

Procedure: Continuous suture in the perineals lesions

Discontinuous suture

ACTIVE COMPARATOR

Interrupted suture technique: vaginal mucosa, perineal muscle and skin are sutured with separate and different threads, that is, the vaginal mucosa is sutured with a thread, then independently the perineal muscle is sutured with another type of thread and finally the skin is also sutured independently with another different thread. Three independent sutures for each of the parts that form a single perineal lesion

Procedure: Discontinuous suture in the perineals lesions

Interventions

Continuous suture in the perineals lesionsPROCEDURE

A continuous suture of the vagina, muscle and skin is performed continuously, without knotting or cutting the suture thread.

Continuous suture
Discontinuous suture in the perineals lesionsPROCEDURE

Suture the muscle independently of the vagina and independently of the skin

Discontinuous suture

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 32601329DERIVED

  • 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.

    PMID: 31842788DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 25, 2019

First Posted

January 31, 2019

Study Start

November 1, 2016

Primary Completion

May 31, 2018

Study Completion

December 31, 2018

Last Updated

January 31, 2019

Record last verified: 2019-01