Obstetric; Injury Pelvic FloorNCT01045135

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

An observational study of Obstetric; Injury Pelvic Floor, run by University Hospital, Akershus at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for: Obstetric; Injury Pelvic Floor
How many people: 300 participants
Where: 1 siteNorway
Study dates: Dec 2009to Jun 2013
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
Women only
Healthy volunteers accepted
Adult

Study population: Women giving birth to their first child at Akershus University Hospital, Norway

Who may be able to join

Women giving birth to their first child at Akershus University Hospital, Norway
Must understand spoken and written Norwegian

Who cannot join

Previous pregnancy of more than 16 weeks
Serious illness mother or child
Birth before pregnancy week 32

Trial locations and contacts

1 site in 1 country.

Norway1 site

Akershus University Hospital
Lørenskog, Akershus

Other trials in Norway

About this study

Injuries to the pelvic floor muscles and fascias during delivery and childbirth may lead to urinary incontinence (25-45 %), faecal incontinence (11-45%), pelvic organ prolapse (7-23%), sexual dysfunction (15-33 %) and chronic pain syndromes (4-15%). Pelvic floor muscle injuries are not easy to diagnose as they are not visible when looking at surface anatomy during a standard gynaecological examination. The investigators are therefore in urgent need of better tools to diagnose these injuries. Having a reliable and easily accessible tool enables studies of the consequences of such pelvic floor muscle injuries. It also makes it possible for us to explore the effect of interventions such as pelvic floor muscle training and surgery in patients with and without pelvic floor muscle injuries. The investigators have previously presented data to support the reliability and the validity of the three and four dimensional (3 and 4D) ultrasound technique used to define pelvic floor muscle anatomy in healthy volunteers and have now a tool to study women before and after delivery. At the Department of Obstetrics and Gynaecology, Akershus University Hospital there are approximately 4500 deliveries annually and 1500 women are giving birth for the first time.

Challenges: The invitation to participate in the study will be given to all women expecting their first child fulfilling inclusion criteria. The biggest challenges in the project will be logistical. To be able to inform, recruit and follow women having their first child is a challenge in it self.

Applications: If it is possible to identify a risk group for pelvic floor injuries before delivery, it might be ethical to recommend a prophylactic caesarean section to avoid disabling incontinence and prolapse later in life.

Conditions: Obstetric; Injury Pelvic Floor
Keywords: Pelvic organ prolapse, Levator hiatus, 3 and 4 dimensional ultrasound
Medical subject headings: Pelvic Organ Prolapse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01045135
Study group	Role	What they receive
first time delivery		Women giving birth to their first child

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Levator Hiatus Area at Rest Measured Via 3-dimensional Ultrasound at 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 giving 3 outcomes
Measured: 21 weeks and 37 weeks of gestation
Change in Levator Hiatus Area at Contraction Measured Via 3D Ultrasound at 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.
Measured: 21 weeks and 37 weeks of gestation
Change in Levator Hiatus Area During Valsalva Maneuver Measured Via 3D Ultrasound
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.
Measured: gestational week 21 and 37

Secondary outcomes (1)

Change in Bladder Neck Mobility Measured Via 3D Ultrasound
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.
Measured: gestational week 21 and 37

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2009Jun 2013

First posted8 Jan 2010 (estimated)
Study startDec 2009
Primary completionOct 2012
Study completionJun 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Obstetric; Injury Pelvic FloorStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01045135
Sponsor's protocol ID: Pelvic floor ultrasound
Status last verified: Feb 2019
First submitted: 7 Jan 2010
Last updated: 18 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Bo K, Hilde G, Staer-Jensen J, Siafarikas F, Tennfjord MK, Engh ME. Does general exercise training before and during pregnancy influence the pelvic floor "opening" and delivery outcome? A 3D/4D ultrasound study following nulliparous pregnant women from mid-pregnancy to childbirth. Br J Sports Med. 2015 Feb;49(3):196-9. doi: 10.1136/bjsports-2014-093548. Epub 2014 Aug 6.
PubMed 25100734

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
Long-term Pelvic Floor and Sexual Health After Obstetric Anal Sphincter Injury in Finland
Obstetric Anal Sphincter Injury, Sexual Dysfunction and the Mode of Deliveries
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
RecruitingObservational study
Hands-on vs Hands-off Techniques in Perineal Protection
Perineal Trauma, Hands-on Technique
Not yet recruitingObservational study
Maternal Musculoskeletal Factors of the Hip, Lumbopelvic, Abdominal and Pelvic Floor Regions and Their Association With Mode of Delivery and Postpartum Pelvic Floor Dysfunction
Pelvic Floor Disorders, Urinary Incontinence
RecruitingPhase 4
Perineal Massage Using A Pelvic Wand During Pregnancy
Pregnancy Related, Pelvic Floor Disorders

All Obstetric; Injury Pelvic Floor trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Pregnancy and Labour on the Pelvic Floor Diagnosed With 3D and 4D Ultrasound
ClinicalTrials.gov ID: NCT01045135
Acronym / sponsor ID: Pelvic floor ultrasound
Conditions: Obstetric; Injury Pelvic Floor
Keywords: Pelvic organ prolapse, Levator hiatus, 3 and 4 dimensional ultrasound
Study type: Observational
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: University Hospital, AkershusUniversity, hospital or other
Collaborators: The Research Council of Norway, South-Eastern Norway Regional Health Authority
Study start: Dec 2009
Primary completion: Oct 2012 (actual)
Study completion: Jun 2013 (actual)
First posted: 8 Jan 2010 (estimated)
Results: Posted 18 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
first time delivery	–	–Women giving birth to their first child

Who may qualify

Ages: 18 to 50 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult
Study population: Women giving birth to their first child at Akershus University Hospital, Norway

Key inclusion criteria (2 listed)

Women giving birth to their first child at Akershus University Hospital, Norway
Must understand spoken and written Norwegian

Key exclusion criteria (3 listed)

Previous pregnancy of more than 16 weeks
Serious illness mother or child
Birth before pregnancy week 32

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Change in Levator Hiatus Area at Rest Measured Via 3-dimensional Ultrasound at Gestational Week 21 and 37.
Time frame: 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
Change in Levator Hiatus Area at Contraction Measured Via 3D Ultrasound at Gestational Week 21 and 37
Time frame: 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.
Change in Levator Hiatus Area During Valsalva Maneuver Measured Via 3D Ultrasound
Time frame: 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.

1 secondary outcome

Change in Bladder Neck Mobility Measured Via 3D Ultrasound
Time frame: gestational week 21 and 37

Results and safety

Results posted to the registry on 18 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
First Time Delivery	300	274

Primary outcome: Change in Levator Hiatus Area at Rest Measured Via 3-dimensional Ultrasound at Gestational Week 21 and 37.

Time frame: 21 weeks and 37 weeks of gestation. Mean (Standard Deviation). Unit: cm

Measure	Primiparous Women Levator Hiatus Area During Valsalva Maneuver n = 274
Value	2.0 (1.7)

Primary outcome: Change in Levator Hiatus Area at Contraction Measured Via 3D Ultrasound at Gestational Week 21 and 37

Time frame: 21 weeks and 37 weeks of gestation. Mean (Standard Deviation). Unit: cm

Measure	Primiparous Women Bladder Neck Mobility Rest to Valsalva Maneu n = 274
Value	1.2 (1.2)

Primary outcome: Change in Levator Hiatus Area During Valsalva Maneuver Measured Via 3D Ultrasound

Time frame: gestational week 21 and 37. Mean (Standard Deviation). Unit: cm

Measure	Primiparous Women Levator Hiatus Area n = 274
Value	3.3 (3.5)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
First Time Delivery	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): We did not examine the women before they were pregnant and therefore do not have information about how the pelvic floor was before pregnancy. It is therefore possible that we have underestimated the change happening to the levator hiatus.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25100734Bo K, Hilde G, Staer-Jensen J, Siafarikas F, Tennfjord MK, Engh ME. Does general exercise training before and during pregnancy influence the pelvic floor "opening" and delivery outcome? A 3D/4D ultrasound study following nulliparous pregnant women from mid-pregnancy to childbirth. Br J Sports Med. 2015 Feb;49(3):196-9. doi: 10.1136/bjsports-2014-093548. Epub 2014 Aug 6.

Related trials for Obstetric; Injury Pelvic Floor

Enrolling by invitationObservational study
Long-term Pelvic Floor and Sexual Health After Obstetric Anal Sphincter Injury in Finland
Obstetric Anal Sphincter Injury, Sexual Dysfunction and the Mode of Deliveries
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
RecruitingObservational study
Hands-on vs Hands-off Techniques in Perineal Protection
Perineal Trauma, Hands-on Technique
Not yet recruitingObservational study
Maternal Musculoskeletal Factors of the Hip, Lumbopelvic, Abdominal and Pelvic Floor Regions and Their Association With Mode of Delivery and Postpartum Pelvic Floor Dysfunction
Pelvic Floor Disorders, Urinary Incontinence
RecruitingPhase 4
Perineal Massage Using A Pelvic Wand During Pregnancy
Pregnancy Related, Pelvic Floor Disorders

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marie E Engh, M.D., PhD study director

University Hospital, Akershus

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Obstetric; Injury Pelvic Floor, run by University Hospital, Akershus at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Levator Hiatus Area at Rest Measured Via 3-dimensional Ultrasound at Gestational Week 21 and 37. (time frame: 21 weeks and 37 weeks of gestation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01045135, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2019.