Levator Hiatal Dimensions and Mode of Delivery

Childbirth Problems Clinical Trial

— LEVDIM  

Official title:

Levator Hiatal Dimensions and Mode of Delivery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05849584
• Other study ID #: 423957
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Ataxia
• Childbirth Problems
• Pelvic Floor Dyssynergia
• Rupture

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