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TraumaNCT02513420

Levator Ani Muscle Avulsion at First Birth of Mexican Women: Randomized Control Trial

A study testing Perineal muscle training in people with Trauma, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Trauma
What is being tested?
Perineal muscle training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteMexico
Study dates
1 Feb 2016to 31 Jul 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Instituto Mexicano del Seguro Social Centro Médico Nacional La Raza

    Mexico City, Mexico City, 02990

Other trials in Mexico

About this study

Official title: Perineal Muscle Training Versus Usual Prenatal Care in the Incidence of Avulsion of the Levator Ani Muscle at First Birth of Mexican Women: Randomized Control Trial

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.

Read the detailed description

This study will be performed in 228 primiparous. Previous informed consent they will be randomized in two groups: 1) perineal muscle training and 2) usual prenatal care. Pelvic floor will be evaluated before and after childbirth clinically and ultrasonographilly. The outcome variables will be: 1) avulsion LAM diagnosed by palpation and 2-3D pelvic floor ultrasound, 2) symptoms of pelvic floor dysfunction identified with standardized and validated Spanish PFDI-20 questionnaire, 3) changes dimension of the genital hiatus and perineal body, 4) accomplishment of perineal muscle training. Demographic variables (marital status, occupation, level of education, age, weeks of gestation, weight, height, BMI, religion, pathologies) and variables related to childbirth (weeks of gestation duration of the second period, use of analgesia, variety of position, episiotomy, forceps. dystocia, who attended the birth, weight and head circumference of the newborn, tearing report and who repairs the last one.

Conditions
Trauma
Being tested
Perineal muscle training
Keywords
levator ani avulsion, perineal muscle training, pelvic floor ultrasound
Medical subject headings
Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Perineal muscle trainingBehavioural

    It is a combination of perineal massage and Kegel exercises.

Study groups in NCT02513420
Study groupRoleWhat they receive
Perineal muscle trainingExperimentalThis 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.
Receives: Behavioral: Perineal muscle training
Usual prental careNo interventionUsually 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Levator ani muscle avulsion

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

    Measured: six weeks after childbith

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2015 (estimated)
  2. Study start1 Feb 2016
  3. Primary completion18 Jul 2018
  4. Study completion31 Jul 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02513420
Sponsor's protocol ID
R-2014-3504-56
Status last verified
Jul 2018
First submitted
29 Jul 2015
Last updated
20 Jul 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 19639235

  • 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.

    PubMed 21985531

  • 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.

    PubMed 22190408

  • 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.

    PubMed 12517644

  • 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.

    PubMed 16394052

  • 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.

    PubMed 15229017

  • 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.

    PubMed 14704241

  • 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.

    PubMed 18513684

  • 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.

    PubMed 19735376

  • 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.

    PubMed 32378735

Questions about this trial

What is this clinical trial studying?

A study testing Perineal muscle training in people with Trauma, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Levator ani muscle avulsion (time frame: six weeks after childbith). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02513420, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2018.

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