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

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02513420
• Other study ID #: R-2014-3504-56
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2016
• Est. completion date: July 31, 2019

Study information

• Verified date: July 2018
• Source: Coordinación de Investigación en Salud, Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Trauma

Intervention

Behavioral:
• Perineal muscle training
It is a combination of perineal massage and Kegel exercises.

Locations

Country	Name	City	State
Mexico	Instituto Mexicano del Seguro Social Centro Médico Nacional La Raza	Mexico City	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Coordinación de Investigación en Salud, Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (9)

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

Outcome

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