Trial Outcomes & Findings for The Effect of Pregnancy and Labour on the Pelvic Floor Diagnosed With 3D and 4D Ultrasound (NCT NCT01045135)

NCT ID: NCT01045135

Last Updated: 2019-02-18

Results Overview

3-dimensional ultrasound was used to capture the axial plane of the pelvic floor in order to measure LH area. Levator hiatus area was measured at gestational week 21 and 37, at rest, during contraction and during Valsalva maneuver - giving 6 measurements all together. The change in LH area was computed between the two different timepoints giving 3 outcomes

• Recruitment status: COMPLETED
• Target enrollment: 300 participants
• Primary outcome timeframe: 21 weeks and 37 weeks of gestation
• Results posted on: 2019-02-18

Participant Flow

January 2010 - july 2011

Participant milestones

Measure	First Time Delivery Women giving birth to their first child
Overall Study STARTED	300
Overall Study COMPLETED	274
Overall Study NOT COMPLETED	26

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Pregnancy and Labour on the Pelvic Floor Diagnosed With 3D and 4D Ultrasound

Baseline characteristics by cohort

Measure	First Time Delivery n=300 Participants Women giving birth to their first child
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	300 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	28.6 years STANDARD_DEVIATION 4.2 • n=5 Participants
Sex: Female, Male Female	300 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Norway	300 participants n=5 Participants

PRIMARY outcome

Timeframe: 21 weeks and 37 weeks of gestation

3-dimensional ultrasound was used to capture the axial plane of the pelvic floor in order to measure LH area. Levator hiatus area was measured at gestational week 21 and 37, at rest, during contraction and during Valsalva maneuver - giving 6 measurements all together. The change in LH area was computed between the two different timepoints giving 3 outcomes

Outcome measures

Measure	Primiparous Women Levator Hiatus Area During Valsalva Maneuver n=274 Participants Women giving birth to their first child
Change in Levator Hiatus Area at Rest Measured Via 3-dimensional Ultrasound at Gestational Week 21 and 37.	2.0 cm Standard Deviation 1.7

PRIMARY outcome

Timeframe: 21 weeks and 37 weeks of gestation

3-dimensional ultrasound was used to capture the axial plane of the pelvic floor in order to measure LH area. Levator hiatus area was measured at gestational week 21 and 37, at rest, during contraction and during Valsalva maneuver - giving 6 measurements all together. The change in LH area was computed between the two different timepoints.

Outcome measures

Measure	Primiparous Women Levator Hiatus Area During Valsalva Maneuver n=274 Participants Women giving birth to their first child
Change in Levator Hiatus Area at Contraction Measured Via 3D Ultrasound at Gestational Week 21 and 37	1.2 cm Standard Deviation 1.2

PRIMARY outcome

Timeframe: gestational week 21 and 37

3-dimensional ultrasound was used to capture the axial plane of the pelvic floor in order to measure LH area. Levator hiatus area was measured at gestational week 21 and 37, at rest, during contraction and during Valsalva maneuver - giving 6 measurements all together. The change in LH area was computed between the two different timepoints.

Outcome measures

Measure	Primiparous Women Levator Hiatus Area During Valsalva Maneuver n=274 Participants Women giving birth to their first child
Change in Levator Hiatus Area During Valsalva Maneuver Measured Via 3D Ultrasound	3.3 cm Standard Deviation 3.5

SECONDARY outcome

Timeframe: gestational week 21 and 37

3-dimensional ultrasound was used to capture the axial plane of the pelvic floor in order to measure LH area. Bladder neck mobility was measured at gestational week 21 and 37, at rest and during Valsalva maneuver . The change in mobility from rest to valsalva was computed between the two different timepoints.

Outcome measures

Measure	Primiparous Women Levator Hiatus Area During Valsalva Maneuver n=274 Participants Women giving birth to their first child
Change in Bladder Neck Mobility Measured Via 3D Ultrasound	-0.11 cm Standard Deviation 0.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 20 months

Outcome measures

Outcome data not reported

Adverse Events

First Time Delivery

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr.Jette Stær-Jensen, Dr. Franziska Siafarikas

Akershus University Hospital

Phone: +47-6796000

Email: jett@ahus.no

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place