A Prospective Study on USS Assessment of Pelvic Structures in 3rd Trimester of Pregnancy Versus Delivery Outcome
NCT ID: NCT02265081
Last Updated: 2015-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
135 participants
INTERVENTIONAL
2014-11-30
2015-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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nulliparous women
internal ultrasound in the 3rd trimester uroflow meter in 3rd trimester
ultrasound
pelvic floor ultrasound
uroflow-meter
uroflow meter: measurement of passed urine volume
parous women
those who had vaginal delivery in the past; internal ultrasound in the 3rd trimester uroflow meter in 3rd trimester
ultrasound
pelvic floor ultrasound
uroflow-meter
uroflow meter: measurement of passed urine volume
parous women - VBAC
those with previous LSCS and no vaginal births; internal ultrasound in the 3rd trimester uroflow meter in 3rd trimester
ultrasound
pelvic floor ultrasound
uroflow-meter
uroflow meter: measurement of passed urine volume
Interventions
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ultrasound
pelvic floor ultrasound
uroflow-meter
uroflow meter: measurement of passed urine volume
Eligibility Criteria
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Inclusion Criteria
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
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
16 Years
50 Years
FEMALE
Yes
Sponsors
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Birmingham Women's NHS Foundation Trust
OTHER_GOV
Responsible Party
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Aneta Obloza
DR ANETA OBLOZA
Principal Investigators
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Kelly Hard
Role: STUDY_CHAIR
R&D Dept, Birmingham Women's Hospital, UK
Locations
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Birmingham Women's Hospital
Birmingham, , United Kingdom
Countries
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Other Identifiers
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U1111-1162-7720
Identifier Type: -
Identifier Source: org_study_id
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