An observational study to investigate the puborectalis muscle by ultrasound in pregnancy and after delivery

Completed

• Conditions: 10028302; 10010273; Difference in muscle composition; impossibility for vaginal delivery

• Registration Number: NL-OMON50211
• Lead Sponsor: Gynaecologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2017-08-23
• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 306

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 implying indication for Caesarean section
(Except for the group of 20 patients undergoing a primary caesarean section)
Connective tissue disease
Not allowed to do a maximum Valsalva maneuver because of cardiac or pulmonary
disease

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>MEP at 12 weeks gestation in the different groups (vaginal delivery versus<br /><br>secondary Caesarean section due to failure of progress).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Mean echogenicity of the cervix, myometrium and vastus lateralis muscle at 12<br /><br>weeks gestation. Mean echogenicity and distribution of different echogenicity<br /><br>of the puborectalis muscle and the change in echogenicity during<br /><br>recovery/regeneration after vaginal delivery. </p><br>