NCT02397941

Brief Summary

Purpose of the study is the assessment of interrectal distance and dimensions of the muscles of the lateral abdominal wall in pregnant and non-pregnant women

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

March 13, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 25, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

March 19, 2020

Status Verified

March 1, 2020

Enrollment Period

4.3 years

First QC Date

March 13, 2015

Last Update Submit

March 17, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • interrectal distance

    baseline

Secondary Outcomes (1)

  • measurement of the abdominal muscles of the lateral abdominal wall by ultrasound.

    baseline

Study Arms (3)

non-pregnant women

20 non-pregnant women, BMI \< 30 kg/m2, Nulligravidas, no abdominal pre-operations, aged 20-45 years, measurement of the abdominal muscles and interrectal distance by ultrasound

Other: Ultrasound

pregnant women

40 pregnant women, BMI \< 30 kg/m2 before pregnancy, Primigravidas, no abdominal pre-operations, aged 20-45 years, measurement of the abdominal muscles and interrectal distance by ultrasound, consecutive measurement during the course of pregnancy

Other: Ultrasound

women who deliverd

20 pregnant women, BMI \< 30 kg/m2 before pregnancy, Primiparas, no abdominal pre-operations, aged 20-45 years, measurement of the abdominal muscles and interrectal distance by ultrasound, measurement after delivery (10 after spontaneous delivery, 10 after elective cesarean section)

Other: Ultrasound

Interventions

ultrasound measures

non-pregnant womenpregnant womenwomen who deliverd

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Inclusion: * non-pregnant women aged 20-45 y with a BMI \< 30 kg/m2 who never were pregnant * pregnant women aged 20-45 y with a BMI \< 30 kg/m2 before pregnancy

You may qualify if:

  • non-pregnant women aged 20-45 y with a BMI \< 30 kg/m2 who never were pregnant
  • pregnant women aged 20-45 y with a BMI \< 30 kg/m2 before pregnancy

You may not qualify if:

  • abdominal pre-operations
  • chronical lung diseases
  • constipation
  • maternal collagenosis
  • polyhydramnion (AFI \> 25)
  • uterus fibroids \> 10 cm
  • inability to perform Valsalva

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Nina Kimmich, MD

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2015

First Posted

March 25, 2015

Study Start

December 1, 2015

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

March 19, 2020

Record last verified: 2020-03

Locations