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

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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Pelvic Floor Disorders
• Intervention / Treatment: Procedure: ultrasound; Procedure: uroflow-meter

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Birmingham, United Kingdom, B29 6SN
    • Birmingham Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: nulliparous women; internal ultrasound in the 3rd trimester uroflow meter in 3rd trimester	Procedure: ultrasound; pelvic floor ultrasound; Procedure: uroflow-meter; uroflow meter: measurement of passed urine volume
Experimental: parous women; those who had vaginal delivery in the past; internal ultrasound in the 3rd trimester uroflow meter in 3rd trimester	Procedure: ultrasound; pelvic floor ultrasound; Procedure: uroflow-meter; uroflow meter: measurement of passed urine volume
Experimental: parous women - VBAC; those with previous LSCS and no vaginal births; internal ultrasound in the 3rd trimester uroflow meter in 3rd trimester	Procedure: ultrasound; pelvic floor ultrasound; Procedure: uroflow-meter; uroflow meter: measurement of passed urine volume

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
vaginal delivery	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
voiding problems	12 months

Collaborators and Investigators

• Sponsor: Birmingham Women's NHS Foundation Trust
• Investigators: Study Chair: Kelly Hard, R&D Dept, Birmingham Women's Hospital, UK

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: October 9, 2014
• First Submitted That Met QC Criteria: October 14, 2014
• First Posted (Estimate): October 15, 2014

Study Record Updates

• Last Update Posted (Estimate): July 28, 2015
• Last Update Submitted That Met QC Criteria: July 26, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Pelvic Floor Disorders
• Other Study ID Numbers: U1111-1162-7720