Skip to content

A Prospective Study on USS Assessment of Pelvic Structures in 3rd Trimester of Pregnancy Versus Delivery Outcome

A Prospective Study on USS Assessment of Pelvic Structures in 3rd Trimester of Pregnancy Versus Delivery Outcome.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02265081
Acronym
PLUSSMODEL
Enrollment
135
Registered
2014-10-15
Start date
2014-11-30
Completion date
2015-07-31
Last updated
2015-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Floor Disorders, Pregnancy

Brief summary

The proposed study is to evaluate if there are specific factors in the pelvic floor functional anatomy which can predict the ability of having a vaginal birth after caesarean section. Physical characteristics of the soft tissue in the female pelvis play an important role in successful vaginal delivery. A tight or less distensible pelvic floor muscles may influence mode of delivery, leading to poor labour progression and by compressing foetal head produce CTG abnormality such as decelerations, both resulting in caesarean delivery. One of the main structures of the pelvic floor, the puborectoalis muscle, facilitates the passage of fetal head through the birth canal by stretching and distending. Therefore distensibility of the female pelvic floor influences mode of delivery. Three hundred patients, in the third trimester of pregnancy, will be recruited via the antenatal clinics to minimize any disruption in their pregnancy care provision. Eligible participants are pregnant women who had either one or no vaginal births, or one caesarean section and who can give an informed consent and maintain their autonomy regarding mode of delivery with understanding of the forthcoming study results. Participants will be excluded if they sustain any obstetric complications that may impede on time and mode of delivery including an emergency prelabour caesarean section. Ultrasonographic assessment of the differences in the pelvic characteristics of these women will be used to predict a successful of trial of vaginal delivery after caesarean section (VBAC) in subsequent pregnancies. The results will be used to better inform whether there is a simple (single ultrasound assessment) that can be used to help inform women's choice regarding mode of delivery. Results from this research could be a pioneering blueprint for further studies, as there is very little known about this topic.

Interventions

PROCEDUREultrasound

pelvic floor ultrasound

PROCEDUREuroflow-meter

uroflow meter: measurement of passed urine volume

Sponsors

Birmingham Women's NHS Foundation Trust
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
16 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

1. English speaking women 2. over 16 years old women 3. women willing to provide written informed consent 4. women who had either prior vaginal delivery or caesarean section or no prior birth experience

Exclusion criteria

1. Women who cannot give an informed consent, 2. under the age of consent, 3. any participants whose pregnancies complicated during the antenatal period that may influence decision on time and mode of delivery that is anyone who has to undergo an emergency prelabour LSCS, 4. nonEnglish speaking women 5. less than 16 years old women

Design outcomes

Primary

MeasureTime frame
vaginal delivery12 months

Secondary

MeasureTime frame
voiding problems12 months

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026