Trauma Clinical Trial
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
Verified date | July 2018 |
Source | Coordinación de Investigación en Salud, Mexico |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 84 |
Est. completion date | July 31, 2019 |
Est. primary completion date | July 18, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Mexico | Instituto Mexicano del Seguro Social Centro Médico Nacional La Raza | Mexico City | Distrito Federal |
Lead Sponsor | Collaborator |
---|---|
Coordinación de Investigación en Salud, Mexico |
Mexico,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Kearney R, Sawhney R, DeLancey JO. Levator ani muscle anatomy evaluated by origin-insertion pairs. Obstet Gynecol. 2004 Jul;104(1):168-73. Review. — View Citation
Krofta L, Otcenásek M, Kasíková 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. — View Citation
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. — View Citation
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. Review. — View Citation
Svabík 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Levator ani muscle avulsion | Lack of insertion of levator ani muscle to pubis identified by pelvic floor ultrasound | six weeks after childbith |
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