NCT03425916

Brief Summary

To describe and compare abdominal muscles and inter-rectus distance conditions in postpartum period in comparison with nulliparous women. Also to describe the activation changes during different abdominal exercises.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
196

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

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

September 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2018

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 8, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2019

Completed
Last Updated

May 7, 2019

Status Verified

May 1, 2019

Enrollment Period

4 months

First QC Date

January 25, 2018

Last Update Submit

May 6, 2019

Conditions

Recti DiastasisPregnancy Related

Keywords

Hypopressive exercisesUltrasonography

Outcome Measures

Primary Outcomes (1)

  • Inter-rectus distance (mm)

    Inter-rectus abdominis distance in mm in rest position.

    1 day

Secondary Outcomes (3)

  • Cross-sectional area (mm)

    1 day

  • Neuromuscular activity (mV)

    1 day

  • Inter-rectus distance (mm) during an hypopressive exercise

    1 day

Study Arms (2)

Primiparous women

Women after normal, not operative, vaginal one-child delivery

Other: Physical therapy intervention

Nulliparous women

Women without any child or pregnancy, age-matched

Interventions

Physical therapy interventionOTHER

Primiparous women start a physical therapy intervention in week 6 after normal one-child delivery, based on abdominal and pelvic floor exercises, education and behavior advices. Abdominal muscle condition and activation are measured by transabdominal ultrasound and surface electromiography. This group is going to be examined after treatment and 6 and 12 months after treatment.

Primiparous women

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primiparous women after normal, not operative, vaginal one-child delivery, recruited 6-7 weeks after delivery from Hospital Universitario Principe de Asturias (Alcala de Henares, Madrid)

You may qualify if:

  • Primiparous women
  • Normal not operative delivery
  • One child delivery

You may not qualify if:

  • Two or more previous gestation
  • Previous abdominal surgery
  • Systemic disease, neurologic or metabolic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beatriz Arranz Martin

Alcalá de Henares, Madrid, 28805, Spain

Location

Study Officials

  • Maria Torres, PhD

    University of Alcala

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

January 25, 2018

First Posted

February 8, 2018

Study Start

September 1, 2017

Primary Completion

January 8, 2018

Study Completion

May 6, 2019

Last Updated

May 7, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)