NCT02513420

Brief Summary

Levator Ani Muscle (LAM) avulsion occurs in 13-36% of women having their first birth. These damages by palpation and ultrasound of the pelvic floor can be detected. Avulsion of the LAM results in decreased muscle strength of the pelvic floor, enlarge the genital hiatus and promotes pelvic organ prolapse. The perineal muscle training is a proposal to combine the perineal massage with pelvic floor exercises in order to prepare the LAM in the last weeks before delivery, to withstand stretching which will be submitted during childbirth. No studies in the world that have explored the effect of the perineal muscle training on the avulsion of MEA. Objective: To quantify the proportion of primiparous that result with avulsion of LAM after their first birth among those performing perineal muscle training from week 33 of gestation and those with usual prenatal care.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 29, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

July 20, 2018

Status Verified

July 1, 2018

Enrollment Period

2.5 years

First QC Date

July 29, 2015

Last Update Submit

July 18, 2018

Conditions

Trauma

Keywords

levator ani avulsionperineal muscle trainingpelvic floor ultrasound

Outcome Measures

Primary Outcomes (1)

  • Levator ani muscle avulsion

    Lack of insertion of levator ani muscle to pubis identified by pelvic floor ultrasound

    six weeks after childbith

Study Arms (2)

Perineal muscle training

EXPERIMENTAL

This group will recibe a training of a combination of perineal massage and pelvic floor muscle excersice that will start after 33 weeks of gestation. Every week until the childbith, They will be evaluated with a diary.

Behavioral: Perineal muscle training

Usual prental care

NO INTERVENTION

Usually pregnant women have not a training focused in pelvic floor muscle, so this group won't receive any indication of pelvic floor training except if They complains of urinary incontinence.

Interventions

Perineal muscle trainingBEHAVIORAL

It is a combination of perineal massage and Kegel exercises.

Perineal muscle training

Eligibility Criteria

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

You may qualify if:

  • Future primiparous over 18 who have single fetus, without contraindications to take delivery. Primigesta omit the term since in the study patients who have had previous pregnancies that are not related to damage to the pelvic floor as will be accepted: abortions, ectopic or molar.
  • With or without symptoms of pelvic floor dysfunction (assessed with PFDI-20 questionnaire).
  • Have 33 weeks gestation to start participating, so the invitation must be made before this gestational age as mentioned above.
  • Physical and mental ability to understand and perform the maneuvers used in the study.

You may not qualify if:

  • Any contraindication to labor, this feature can appear at any time during pregnancy, including during labor.
  • Physical or mental inability to perform the maneuvers used in the study.
  • Avulsion of MEA detected before birth.
  • Agree not participate in the study.
  • Previous pregnancies older than 20 weeks gestation resolved abdominally.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Mexicano del Seguro Social Centro Médico Nacional La Raza

Mexico City, Mexico City, 02990, Mexico

Location

Related Publications (10)

  • Krofta L, Otcenasek M, Kasikova E, Feyereisl J. Pubococcygeus-puborectalis trauma after forceps delivery: evaluation of the levator ani muscle with 3D/4D ultrasound. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Oct;20(10):1175-81. doi: 10.1007/s00192-009-0837-6. Epub 2009 Jul 29.

    PMID: 19639235BACKGROUND

  • Albrich SB, Laterza RM, Skala C, Salvatore S, Koelbl H, Naumann G. Impact of mode of delivery on levator morphology: a prospective observational study with three-dimensional ultrasound early in the postpartum period. BJOG. 2012 Jan;119(1):51-60. doi: 10.1111/j.1471-0528.2011.03152.x. Epub 2011 Oct 10.

    PMID: 21985531BACKGROUND

  • Schwertner-Tiepelmann N, Thakar R, Sultan AH, Tunn R. Obstetric levator ani muscle injuries: current status. Ultrasound Obstet Gynecol. 2012 Apr;39(4):372-83. doi: 10.1002/uog.11080.

    PMID: 22190408BACKGROUND

  • DeLancey JO, Kearney R, Chou Q, Speights S, Binno S. The appearance of levator ani muscle abnormalities in magnetic resonance images after vaginal delivery. Obstet Gynecol. 2003 Jan;101(1):46-53. doi: 10.1016/s0029-7844(02)02465-1.

    PMID: 12517644BACKGROUND

  • Kearney R, Miller JM, Ashton-Miller JA, DeLancey JO. Obstetric factors associated with levator ani muscle injury after vaginal birth. Obstet Gynecol. 2006 Jan;107(1):144-9. doi: 10.1097/01.AOG.0000194063.63206.1c.

    PMID: 16394052BACKGROUND

  • Kearney R, Sawhney R, DeLancey JO. Levator ani muscle anatomy evaluated by origin-insertion pairs. Obstet Gynecol. 2004 Jul;104(1):168-73. doi: 10.1097/01.AOG.0000128906.61529.6b.

    PMID: 15229017BACKGROUND

  • Lien KC, Mooney B, DeLancey JO, Ashton-Miller JA. Levator ani muscle stretch induced by simulated vaginal birth. Obstet Gynecol. 2004 Jan;103(1):31-40. doi: 10.1097/01.AOG.0000109207.22354.65.

    PMID: 14704241BACKGROUND

  • Hoyte L, Damaser MS, Warfield SK, Chukkapalli G, Majumdar A, Choi DJ, Trivedi A, Krysl P. Quantity and distribution of levator ani stretch during simulated vaginal childbirth. Am J Obstet Gynecol. 2008 Aug;199(2):198.e1-5. doi: 10.1016/j.ajog.2008.04.027. Epub 2008 Jun 2.

    PMID: 18513684BACKGROUND

  • Svabik K, Shek KL, Dietz HP. How much does the levator hiatus have to stretch during childbirth? BJOG. 2009 Nov;116(12):1657-62. doi: 10.1111/j.1471-0528.2009.02321.x. Epub 2009 Sep 1.

    PMID: 19735376BACKGROUND

  • Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.

    PMID: 32378735DERIVED

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Daniel Vélez, M.Sc.

    Colegio Mexicano de Ginecología y Obstetricia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical specialist

Study Record Dates

First Submitted

July 29, 2015

First Posted

July 31, 2015

Study Start

February 1, 2016

Primary Completion

July 18, 2018

Study Completion

July 31, 2019

Last Updated

July 20, 2018

Record last verified: 2018-07

Locations

ME(1)