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

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ClinicalTrials.gov Identifier: NCT02513420
Recruitment Status : Active, not recruiting
First Posted : July 31, 2015
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
Daniel Velez Sanchez, Coordinación de Investigación en Salud, Mexico

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.


Condition or disease Intervention/treatment Phase
Trauma Behavioral: Perineal muscle training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
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
Actual Study Start Date : February 1, 2016
Actual Primary Completion Date : July 18, 2018
Estimated Study Completion Date : July 31, 2019

Arm Intervention/treatment
Experimental: Perineal muscle training
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
It is a combination of perineal massage and Kegel exercises.

No Intervention: Usual prental care
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.



Primary Outcome Measures :
  1. Levator ani muscle avulsion [ Time Frame: six weeks after childbith ]
    Lack of insertion of levator ani muscle to pubis identified by pelvic floor ultrasound



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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.
  2. With or without symptoms of pelvic floor dysfunction (assessed with PFDI-20 questionnaire).
  3. Have 33 weeks gestation to start participating, so the invitation must be made before this gestational age as mentioned above.
  4. Physical and mental ability to understand and perform the maneuvers used in the study.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02513420


Locations
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Mexico
Instituto Mexicano del Seguro Social Centro Médico Nacional La Raza
Mexico City, Distrito Federal, Mexico, 02990
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
Investigators
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Principal Investigator: Daniel Vélez, M.Sc. Colegio Mexicano de Ginecología y Obstetricia

Publications:

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Responsible Party: Daniel Velez Sanchez, Medical specialist, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT02513420     History of Changes
Other Study ID Numbers: R-2014-3504-56
First Posted: July 31, 2015    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
Keywords provided by Daniel Velez Sanchez, Coordinación de Investigación en Salud, Mexico:
levator ani avulsion
perineal muscle training
pelvic floor ultrasound
Additional relevant MeSH terms:
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Fractures, Avulsion
Fractures, Bone
Wounds and Injuries