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De musculus puborectalis tijdens de zwangerschap en na de bevalling.


- candidate number20882
- NTR NumberNTR4882
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-nov-2014
- Secondary IDsNL49202.041.14 METC UMC Utrecht 14-482
- Public TitleDe musculus puborectalis tijdens de zwangerschap en na de bevalling.
- Scientific TitleAn observational study to investigate the puborectalis muscle by ultrasound in pregnancy and after delivery.
- ACRONYMPURE PUboRectalis Echogenicity
- hypothesisThe mean echogenicity of the puborectalis muscle in nulliparous women at 12 weeks gestation is lower in women delivering by Caesarean section due to failure to progress compared to women delivering vaginally.
- Healt Condition(s) or Problem(s) studiedPregnancy, Labour, Failure to progress, Muscle regeneration
- Inclusion criteria-Nulliparous women
-Singleton pregnancy
-Good knowledge of Dutch language
-Signed informed consent
- Exclusion criteria-Age <18 years
-History of pelvic organ prolapse or incontinence surgery
-History of surgery in the uterus (indication for Caesarean section)
-Connective tissue disease
-Not allowed to do a maximum Valsalva maneuver because of cardiac or pulmonary disease
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 6-mrt-2015
- planned closingdate1-jan-2017
- Target number of participants306
- InterventionsPerforming ultrasound assessment of the pelvic floor, cervix, myometrium and vastus lateralis muscle at 12 weeks gestation. Twenty patients of the UMCU (UVC/WKZ) will have intensive follow-up after vaginal delivery to assess regeneration after delivery trauma.
- Primary outcomeMean echogenicity of the puborectalis muscle (MEP) at 12 weeks gestation in the different delivery groups (vaginal delivery versus secondary Caesarean section due to failure of progress).
- Secondary outcomeMean echogenicity of the cervix, myometrium and vastus lateralis muscle at 12 weeks gestation in the two groups. Mean echogenicity and distribution of different echogenicity of the puborectalis muscle and the change in echogenicity during recovery/regeneration after vaginal delivery.
- TimepointsUltrasound assessment at 12 weeks pregnancy. Twenty patients will undergo intensive postpartum follow-up 1 day, 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 12 weeks, (16 weeks), 18 weeks and 24 weeks after delivery.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD M.K. Waarsenburg, van de
- CONTACT for SCIENTIFIC QUERIESMD M.K. Waarsenburg, van de
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD5-nov-2014 - 20-apr-2015


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