Pelvic Floor; RuptureLEVDIMNCT05849584
Levator Hiatal Dimensions and Mode of Delivery
An observational study of Pelvic Floor; Rupture and Childbirth Problems, run by St. Olavs Hospital at 2 sites in Norway.
Trial summary
The aim of this observational study is to learn about how muscle dimensions of the pelvic floor measured during pregnancy in primigravida impact birth mecanics and mode of delivery. Tha main aims are to 1. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor; Rupture, Childbirth Problems, Pelvic Floor Dyssynergia
- What is being tested?
- Transperineal ultrasound
- How many people
- 0 participants
- Where
- 2 sitesNorway
- Study dates
- 5 Feb 2024to 1 Oct 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 400 nulliparous pregnant women recruited at routine ultrasound scan i nearly pregnancy
Who may be able to join
- Age over 18 years
- Ability to consent
- Singleton pregnancy
Who cannot join
- Previous deliveries > 16 weeks gestation
- Previous pelvic floor surgery
- Anomalies affecting the pelvic floor function (such as myelomeningocele)
- Epilepsy, since this might influence intervention during delivery
- Women with elective cesarean
Trial locations and contacts
2 sites in 1 country.
About this study
The aim of this observational study is to learn about how muscle dimensions of the pelvic floor measured during pregnancy in primigravida impact birth mecanics and mode of delivery. Tha main aims are to 1. Explore associations between mode of delivery and hiatal dimensions measured by transperineal ultrasound antenatally and 2. Explore the association between duration of 2nd stage of labour and hiatal dimensions.
A pelvic floor ultrasound examination will be performed between pregnancy week 12 and 20 and levator ani muscle hiatal dimensions will be compared between women having a normal vaginal delivery and women with emergency cesarean or operative vaginal deliveries.
Read the detailed description
The women will be enrolled and examined at the 12-week routine ultrasound examination after informed consent and examined again at the 18 weeks gestation examination. The women will be examined in the supine position on a bed with knees and hips semi-flexed and abducted. Bladder and bowel should be emptied prior to the examination. They will be instructed in how to perform pelvic floor contraction and maximal Valsalva maneuver.
First, a 2D scan will be performed of one experienced clinician. The average of 3 2D levator hiatal anteroposterior measurements will be stored. Then, a 3D/4D ultrasound examination of the pelvic floor will be performed using a Voluson S10, E8 or E10 (GE healthcare, Zipf, Austria) device with a RAB 4-8 MHz curved array transducer with the acquisition angle set at 85 degrees. Offline analysis of the ultrasound volumes will be performed using the 4D view (GE Healthcare, Austria) software, blinded to all clinical data. Hiatal anteroposterior diameter will be measured in both 2D and 3D. Hiatal area and hiatal transverse diameter will be measured in the 3D volume. These measures have previously been demonstrated to have high interrater and intrarater reliability in women in this study population.
Details regarding maternal height, weight, age, ethnicity, marital status, employment, induction of labour, duration of active 2nd stage of labour, gestational length, use of epidural analgesia, indication for operative delivery (slow progress or fetal distress), mode of delivery (forceps, vacuum, cesarean section), infant birthweight, head circumference, Presentation (occiput anterior/ posterior), head station at intervention, infant gender, Apgar score, perineal trauma, postpartum hemorrhage, will be collected from electronic patient journals after delivery. The women will be informed that they may be contacted within 2 years after delivery for a follow up, but separate consent will be needed.
Participants will have a unique study number and the coupling list will be stored on a safe area at St. Olav's server.
- Being tested
- Transperineal ultrasound
- Medical subject headings
- Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transperineal ultrasoundOther
A 2D scan will be performed of one experienced clinician. The average of 3 2D levator hiatal anteroposterior measurements will be stored. Then, a 3D/4D ultrasound examination of the pelvic floor will be performed using a Voluson S10, E8 or E10 (GE healthcare, Zipf, Austria) device with a RAB 4-8 MHz curved array transducer with the acquisition angle set at 85 degrees. Offline analysis of the ultrasound volumes will be performed using the 4D view (GE Healthcare, Austria) software, blinded to all clinical data. Hiatal anteroposterior diameter will be measured in both 2D and 3D. Hiatal area and hiatal transverse diameter will be measured in the 3D volume
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Not described Receives: Other: Transperineal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mode of delivery
Normal vaginal, vacuum assisted vaginal, forceps assisted vaginal or emergency cesarean delivery
Measured: Assessed at 1 day of childbirth
Levator hiatal dimensions
levator hiatal anteroposterior diameter and levator hiatal area at rest measured with 2D and 3D ultrasound
Measured: Measured in pregnancy week 12
Levator hiatal dimensions
levator hiatal anteroposterior diameter and levator hiatal area at rest measured with 2D and 3D ultrasound
Measured: Measured in pregnancy week 18
Secondary outcomes (5)
Duration of second stage of delivery
Number of minutes from full dillatation of the cervix until the baby is born
Measured: Assessed at 1 day of childbirth
Pernineal tears
Grade of perineal tear. No tear, grade 1, 2, 3, 4 or deep vaginal tear
Measured: Assessed at 1 day of childbirth
Postpartum haemorrage
Amount in ml of postpartum haemmorage
Measured: Assessed at 1 day of childbirth
womans experience of transperineal ultrasound
Qualitative assessment of the womans experience of transperineal ultrasound
Measured: Assessed at pregnancy week 12 and week 18
Interrater validity of ultrasound measurements
For analysis of intrarater reliability for ultrasound measurements, we will use the intraclass correlation coefficient (ICC) two-way mixed effects, absolute agreement model. To determine interrater reliability, we will use the ICC two-way random effects, absolute agreement model, applying both the mean of three raters and single measurements. [20]. The following ICC cut-offs will be applied: < 0.20 = poor reliability, 0.20-0.40 = fair reliability, 0.41-0.60 = moderate reliability, 0.61-0.80 = good reliability and > 0.80 = excellent reliability
Measured: Assessed 3 months after childbirth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start5 Feb 2024 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Why it stopped: The study will not proceed due to lack of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor; RuptureStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- 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
- 0 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ingrid Volløyhaug, PhD, Principal investigator, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849584
- Sponsor's protocol ID
- 423957
- Acronym
- LEVDIM
- Status last verified
- Jun 2025
- First submitted
- 19 Jan 2023
- Last updated
- 24 Jun 2025
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levator Hiatal Dimensions and Mode of Delivery
- ClinicalTrials.gov ID
- NCT05849584
- Acronym / sponsor ID
- LEVDIM / 423957
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study will not proceed due to lack of funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Study start
- 5 Feb 2024 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this observational study is to learn about how muscle dimensions of the pelvic floor measured during pregnancy in primigravida impact birth mecanics and mode of delivery. Tha main aims are to 1. Explore associations between mode of delivery and hiatal dimensions measured by transperineal ultrasound antenatally and 2. Explore the association between duration of 2nd stage of labour and hiatal dimensions.
A pelvic floor ultrasound examination will be performed between pregnancy week 12 and 20 and levator ani muscle hiatal dimensions will be compared between women having a normal vaginal delivery and women with emergency cesarean or operative vaginal deliveries.
Detailed description
The women will be enrolled and examined at the 12-week routine ultrasound examination after informed consent and examined again at the 18 weeks gestation examination. The women will be examined in the supine position on a bed with knees and hips semi-flexed and abducted. Bladder and bowel should be emptied prior to the examination. They will be instructed in how to perform pelvic floor contraction and maximal Valsalva maneuver.
First, a 2D scan will be performed of one experienced clinician. The average of 3 2D levator hiatal anteroposterior measurements will be stored. Then, a 3D/4D ultrasound examination of the pelvic floor will be performed using a Voluson S10, E8 or E10 (GE healthcare, Zipf, Austria) device with a RAB 4-8 MHz curved array transducer with the acquisition angle set at 85 degrees. Offline analysis of the ultrasound volumes will be performed using the 4D view (GE Healthcare, Austria) software, blinded to all clinical data. Hiatal anteroposterior diameter will be measured in both 2D and 3D. Hiatal area and hiatal transverse diameter will be measured in the 3D volume. These measures have previously been demonstrated to have high interrater and intrarater reliability in women in this study population.
Details regarding maternal height, weight, age, ethnicity, marital status, employment, induction of labour, duration of active 2nd stage of labour, gestational length, use of epidural analgesia, indication for operative delivery (slow progress or fetal distress), mode of delivery (forceps, vacuum, cesarean section), infant birthweight, head circumference, Presentation (occiput anterior/ posterior), head station at intervention, infant gender, Apgar score, perineal trauma, postpartum hemorrhage, will be collected from electronic patient journals after delivery. The women will be informed that they may be contacted within 2 years after delivery for a follow up, but separate consent will be needed.
Participants will have a unique study number and the coupling list will be stored on a safe area at St. Olav's server.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | Other: Transperineal ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 400 nulliparous pregnant women recruited at routine ultrasound scan i nearly pregnancy
Key inclusion criteria (3 listed)
- Age over 18 years
- Ability to consent
- Singleton pregnancy
Key exclusion criteria (5 listed)
- Previous deliveries > 16 weeks gestation
- Previous pelvic floor surgery
- Anomalies affecting the pelvic floor function (such as myelomeningocele)
- Epilepsy, since this might influence intervention during delivery
- Women with elective cesarean
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transperineal ultrasoundA 2D scan will be performed of one experienced clinician. The average of 3 2D levator hiatal anteroposterior measurements will be stored. Then, a 3D/4D ultrasound examination of the pelvic floor will be performed using a Voluson S10, E8 or E10 (GE healthcare, Zipf, Austria) device with a RAB 4-8 MHz curved array transducer with the acquisition angle set at 85 degrees. Offline analysis of the ultrasound volumes will be performed using the 4D view (GE Healthcare, Austria) software, blinded to all clinical data. Hiatal anteroposterior diameter will be measured in both 2D and 3D. Hiatal area and hiatal transverse diameter will be measured in the 3D volume | Other | Pregnant women |
Primary outcome
Mode of delivery
Time frame: Assessed at 1 day of childbirth
Normal vaginal, vacuum assisted vaginal, forceps assisted vaginal or emergency cesarean delivery
Levator hiatal dimensions
Time frame: Measured in pregnancy week 12
levator hiatal anteroposterior diameter and levator hiatal area at rest measured with 2D and 3D ultrasound
Levator hiatal dimensions
Time frame: Measured in pregnancy week 18
levator hiatal anteroposterior diameter and levator hiatal area at rest measured with 2D and 3D ultrasound
5 secondary outcomes
Duration of second stage of delivery
Time frame: Assessed at 1 day of childbirth
Pernineal tears
Time frame: Assessed at 1 day of childbirth
Postpartum haemorrage
Time frame: Assessed at 1 day of childbirth
womans experience of transperineal ultrasound
Time frame: Assessed at pregnancy week 12 and week 18
Interrater validity of ultrasound measurements
Time frame: Assessed 3 months after childbirth
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Pelvic Floor; Rupture
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
Active, not recruiting
Comparison of the Flexibility of the Perineum in Primiparous Women Using the Medical Device Emagina During 90 Days of Their Pregnancy Compared to Those Having a Standard Pregnancy Follow-up
Pregnancy, Childbirth
RecruitingObservational study
Hands-on vs Hands-off Techniques in Perineal Protection
Perineal Trauma, Hands-on Technique
Recruiting
Physiotherapeutic Protocol Compared to Usual Care in the Treatment of Primiparas After Perineal Trauma
Episiotomy, Lacerations Perineal
Recruiting
Pushing Using Real-time Sonographic Ultrasound Education
Transperineal Ultrasound, Midwife-led Pushing Training Program
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.
Ingrid Volløyhaug, PhD principal investigator
St. Olavs Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Floor; Rupture and Childbirth Problems, run by St. Olavs Hospital at 2 sites 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 3 inclusion and 5 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: withdrawn, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Mode of delivery (time frame: Assessed at 1 day of childbirth). 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?
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 24 Jun 2025.