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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05849584
Other study ID # 423957
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 5, 2024
Est. completion date October 1, 2025

Study information

Verified date December 2023
Source St. Olavs Hospital
Contact Ingrid Volløyhaug, PhD
Phone 97549124
Email ingrid.volloyhaug@ntnu.no
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 400
Est. completion date October 1, 2025
Est. primary completion date October 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria - Age over 18 years - Ability to consent - Singleton pregnancy Exclusion criteria - 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

Study Design


Intervention

Other:
Transperineal ultrasound
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

Locations

Country Name City State
Norway Levanger Sykehus Levanger
Norway st.Olavs hospital Trondheim

Sponsors (1)

Lead Sponsor Collaborator
St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mode of delivery Normal vaginal, vacuum assisted vaginal, forceps assisted vaginal or emergency cesarean delivery Assessed at 1 day of childbirth
Primary Levator hiatal dimensions levator hiatal anteroposterior diameter and levator hiatal area at rest measured with 2D and 3D ultrasound Measured in pregnancy week 12
Primary Levator hiatal dimensions levator hiatal anteroposterior diameter and levator hiatal area at rest measured with 2D and 3D ultrasound Measured in pregnancy week 18
Secondary Duration of second stage of delivery Number of minutes from full dillatation of the cervix until the baby is born Assessed at 1 day of childbirth
Secondary Pernineal tears Grade of perineal tear. No tear, grade 1, 2, 3, 4 or deep vaginal tear Assessed at 1 day of childbirth
Secondary Postpartum haemorrage Amount in ml of postpartum haemmorage Assessed at 1 day of childbirth
Secondary womans experience of transperineal ultrasound Qualitative assessment of the womans experience of transperineal ultrasound Assessed at pregnancy week 12 and week 18
Secondary 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 Assessed 3 months after childbirth
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