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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

Tracking Information
First Submitted Date  ICMJE July 29, 2015
First Posted Date  ICMJE July 31, 2015
Last Update Posted Date July 20, 2018
Actual Study Start Date  ICMJE February 1, 2016
Actual Primary Completion Date July 18, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2015)
Levator ani muscle avulsion [ Time Frame: six weeks after childbith ]
Lack of insertion of levator ani muscle to pubis identified by pelvic floor ultrasound
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02513420 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Levator Ani Muscle Avulsion at First Birth of Mexican Women: Randomized Control Trial
Official Title  ICMJE 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
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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Trauma
Intervention  ICMJE Behavioral: Perineal muscle training
It is a combination of perineal massage and Kegel exercises.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Perineal muscle training
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 18, 2018)
84
Original Estimated Enrollment  ICMJE
 (submitted: July 30, 2015)
228
Estimated Study Completion Date  ICMJE July 31, 2019
Actual Primary Completion Date July 18, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02513420
Other Study ID Numbers  ICMJE R-2014-3504-56
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daniel Velez Sanchez, Coordinación de Investigación en Salud, Mexico
Study Sponsor  ICMJE Coordinación de Investigación en Salud, Mexico
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniel Vélez, M.Sc. Colegio Mexicano de Ginecología y Obstetricia
PRS Account Coordinación de Investigación en Salud, Mexico
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP