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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
- Levator ani muscle avulsion [ Time Frame: six weeks after childbith ]Lack of insertion of levator ani muscle to pubis identified by pelvic floor ultrasound
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
|Instituto Mexicano del Seguro Social Centro Médico Nacional La Raza|
|Mexico City, Distrito Federal, Mexico, 02990|
|Principal Investigator:||Daniel Vélez, M.Sc.||Colegio Mexicano de Ginecología y Obstetricia|