Trial document




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  DRKS00010132

Trial Description

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Title

Levator Ani Muscle Co-Activation Nulliparous Women At Term and Labor Outcome

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

In our study we examine the effect of coactivation of the pelvic floor muscles. coactivation of the pelvic floor muscles is abnormal situation, where a patient performs a valsalva manouver (bearing down), while the pelvic floor contracts instead of relaxing. This could pose an obstacle for a vaginal birth. This fact was not examined until now. We will examine the pelvic floor muscles to rule out a coactivation of the pelvic floor muscles via a ultrasound done on the perineum (translabial ultrasound). In this ultrasound we present the symphysis bone until the hindgut (rectum). This is called introitus. During bearing down, the introitus should widen. In case of shortening or no change, coactivation is diagnosed. These measurements will be correlated with intrapartal datra to see whether a coactivation elevates the risk for an operative delivery.

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Brief Summary in Scientific Language

To assess the significance of levator ani co-activation on labor outcome.
To assess the effect of visual feedback on the efficacy of Valsalva maneuver

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Organizational Data

  •   DRKS00010132
  •   2016/03/09
  •   [---]*
  •   yes
  •   Approved
  •   16/16, Ethik-Kommission bei der Ärztekammer des Saarlandes
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Secondary IDs

  •   U1111-1180-2596 
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Health Condition or Problem studied

  •   O80 -  Single spontaneous delivery
  •   O81 -  Single delivery by forceps and vacuum extractor
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Interventions/Observational Groups

  •   A pelvic floor sonography will be done. During a valsalva manoeuvre the introitus will be measured. The birth will be awaited. The introitus opening done prenpartally will be compared between patients giving birth vaginally or operatively.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

We are dealing with a predictive study, whethere the to be predicted parameter ist the mode of delivery: vaginal vs. operative. We are trying to find out, whether the coactivation of the pelvic floor muscles is an obstacle to vaginal birth.

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Secondary Outcome

Duration of second stage of delivery
Neonatale outcome
fetal head position

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Countries of Recruitment

  •   Germany
  •   Italy
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/02/25
  •   390
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Female
  •   16   Years
  •   no maximum age
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Additional Inclusion Criteria

Primiparous women with a singleton live fetus in cephalic presentation at term (≥ 35 weeks) presenting to the outpatient clinic for routine assessment at term.

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Exclusion Criteria

-Fetal or maternal diseases associated with a higher risk of fetal asphyxia or operative delivery (e.g. maternal Diabetes Mellitus, hypertensive disorder, intrauterine growth restriction)
-Patient below 16 years of age.
-Patients with poor compliance due to language barriers.

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Addresses

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    • Universitätsklinikum des Saarlandes
    • 66421  Homburg/Saar
    • Germany
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    • Klinik für Frauenheilkunde und GeburtshilfeUniversität Bologna
    • Mr.  Dr.  Aly  Youssef 
    • Bologna
    • Italy
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    • Universitätsklinikum des Saarlandes
    • Mr.  Amr  Hamza 
    • Kirrberger Str. 100
    • 66424  Homburg
    • Germany
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    • Universitätsklinikum des Saarlandes
    • Mr.  Amr  Hamza 
    • Kirrberger Str. 100
    • 66424  Homburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum des Saarlandes
    • Mr.  Amr  Hamza 
    • Kirrberger Str. 100
    • 66424  Homburg
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.