NCT03149965

Brief Summary

The hypothesis was that the anovaginal distance (AVD), defined as the distance between the anal mucosa and the vaginal wall at the middle level of the anal canal, is higher in obese women compared with normal weight women. Measuring the AVD with transperineal ultrasound has been shown to have a high interobserver agreement. This study aimed to establish if there was a difference in AVD measured by transperineal ultrasound between obese and normal weight women in active phase of labor at term pregnancy. The second aim was to present normal values for the AVD in active phase of labor at term pregnancy.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Oct 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 2, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 11, 2017

Completed
Last Updated

May 16, 2017

Status Verified

May 1, 2017

Enrollment Period

1.5 years

First QC Date

May 9, 2017

Last Update Submit

May 14, 2017

Conditions

ObesityPregnancy

Outcome Measures

Primary Outcomes (1)

  • anovaginal distance

    millimeter

    five minutes

Study Arms (2)

Body mass index 18.5-24.9

ACTIVE COMPARATOR

The anovaginal distance was measured with transperineal ultrasound. The standardized method consisted of placing the vaginal probe at a right angle to the posterior vaginal distal wall, and in a transversal scanning plane. The internal anal sphincter was detected as a low-echogenic ring when the probe was moved cranially from the distal anal canal to the mid anal canal. The anovaginal distance was defined as the distance between the anal mucosa and the vaginal wall at the middle level of the anal.

Other: transperineal ultrasound

body mass index ≥30

EXPERIMENTAL

The anovaginal distance was measured with transperineal ultrasound. The standardized method consisted of placing the vaginal probe at a right angle to the posterior vaginal distal wall, and in a transversal scanning plane. The internal anal sphincter was detected as a low-echogenic ring when the probe was moved cranially from the distal anal canal to the mid anal canal. The anovaginal distance was defined as the distance between the anal mucosa and the vaginal wall at the middle level of the anal.

Other: transperineal ultrasound

Interventions

transperineal ultrasoundOTHER

transperineal ultrasound was used by placing a vaginal ultrasound probe towards the vaginal distal wall pointing to the anus, measuring the anovaginal distance.

Body mass index 18.5-24.9body mass index ≥30

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Active labor according to the Swedish definition; two out of three of the following criteria must be present: painful contractions (two to three contractions in every ten minutes), cervix shortened and dilated \> one centimeter (cm) and/or rupture of membranes.
  • The maximum cervix dilatation was of seven centimeters.
  • The participant had to be aged ≥18 years
  • The participant had to be proficient in the Swedish language

You may not qualify if:

  • Not in active labor,
  • Cervix dilatation of more than seven centimeters,
  • Age \<19
  • Not speaking Swedish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hjertberg L, Uustal E, Pihl S, Blomberg M. Maternal Body Mass Index and Anovaginal Distance in Active Phase of Term Labor. Biomed Res Int. 2018 Mar 7;2018:1532949. doi: 10.1155/2018/1532949. eCollection 2018.

    PMID: 29707565DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marie Blomberg, Assoc prof

    Departement of obstetrics and gynecology, Linkopings University, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: prospective cohort study
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated professor

Study Record Dates

First Submitted

May 9, 2017

First Posted

May 11, 2017

Study Start

October 2, 2014

Primary Completion

March 31, 2016

Study Completion

March 31, 2016

Last Updated

May 16, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share