Clinical trial NCT05849584: Levator Hiatal Dimensions and Mode of Delivery
Official title: Levator Hiatal Dimensions and Mode of Delivery
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pelvic Floor; Rupture
Childbirth Problems
Pelvic Floor Dyssynergia
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 400 nulliparous pregnant women recruited at routine ultrasound scan i nearly pregnancy

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mode of delivery
timeFrame: Assessed at 1 day of childbirth
measure: Levator hiatal dimensions
timeFrame: Measured in pregnancy week 12
measure: Levator hiatal dimensions
timeFrame: Measured in pregnancy week 18
Secondary outcomes:
measure: Duration of second stage of delivery
timeFrame: Assessed at 1 day of childbirth
measure: Pernineal tears
timeFrame: Assessed at 1 day of childbirth
measure: Postpartum haemorrage
timeFrame: Assessed at 1 day of childbirth
measure: womans experience of transperineal ultrasound
timeFrame: Assessed at pregnancy week 12 and week 18
measure: Interrater validity of ultrasound measurements
timeFrame: Assessed 3 months after childbirth
Other outcomes:
Locations:
city: Levanger
country: Norway
facility: Levanger Sykehus
city: Trondheim
country: Norway
facility: st.Olavs hospital
Study officials:
affiliation: St. Olavs Hospital
name: Ingrid Volløyhaug, PhD
role: PRINCIPAL_INVESTIGATOR
References: