NCT02265081

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 15, 2014

Completed
17 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

July 28, 2015

Status Verified

July 1, 2015

Enrollment Period

8 months

First QC Date

October 9, 2014

Last Update Submit

July 26, 2015

Conditions

Pelvic Floor DisordersPregnancy

Outcome Measures

Primary Outcomes (1)

  • vaginal delivery

    12 months

Secondary Outcomes (1)

  • voiding problems

    12 months

Study Arms (3)

nulliparous women

ACTIVE COMPARATOR

internal ultrasound in the 3rd trimester uroflow meter in 3rd trimester

Procedure: ultrasoundProcedure: uroflow-meter

parous women

EXPERIMENTAL

those who had vaginal delivery in the past; internal ultrasound in the 3rd trimester uroflow meter in 3rd trimester

Procedure: ultrasoundProcedure: uroflow-meter

parous women - VBAC

EXPERIMENTAL

those with previous LSCS and no vaginal births; internal ultrasound in the 3rd trimester uroflow meter in 3rd trimester

Procedure: ultrasoundProcedure: uroflow-meter

Interventions

ultrasoundPROCEDURE

pelvic floor ultrasound

nulliparous womenparous womenparous women - VBAC
uroflow-meterPROCEDURE

uroflow meter: measurement of passed urine volume

nulliparous womenparous womenparous women - VBAC

Eligibility Criteria

Age16 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Women who cannot give an informed consent,
  • under the age of consent,
  • 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,
  • nonEnglish speaking women
  • less than 16 years old women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Birmingham Women's Hospital

Birmingham, B29 6SN, United Kingdom

Location

MeSH Terms

Conditions

Pelvic Floor Disorders

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPregnancy ComplicationsMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Kelly Hard

    R&D Dept, Birmingham Women's Hospital, UK

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DR ANETA OBLOZA

Study Record Dates

First Submitted

October 9, 2014

First Posted

October 15, 2014

Study Start

November 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

July 28, 2015

Record last verified: 2015-07

Locations

GB(1)