Changes in Abdominal Muscles Performance in Postpartum Women.

May 6, 2019 updated by: Beatriz Arranz Martin, University of Alcala

Changes in Abdominal Muscles Performance and Inter-rectus Distance in Postpartum Women: an Ultrasonography and Electromyographic Study.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pregnancy and childbirth cause corporal changes in women, altering the structure and function of the abdominal and pelvic floor muscles. The distension of the muscular tissue and the possible diastasis recti can alter the performance of the abdominal musculature in the control of intra-abdominal pressure and the lumbo-pelvic stabilization in postpartum term. Abdominal exercise is highly recommended to restore these changes but there is not enough evidence about the effects of exercise modalities.

Study Type

Observational

Enrollment (Actual)

196

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Alcalá De Henares, Madrid, Spain, 28805
        • Beatriz Arranz Martin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-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)

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Primiparous women
Women after normal, not operative, vaginal one-child delivery
Other: Physical therapy intervention
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.
Nulliparous women
Women without any child or pregnancy, age-matched

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inter-rectus distance (mm)
Time Frame: 1 day
Inter-rectus abdominis distance in mm in rest position.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cross-sectional area (mm)
Time Frame: 1 day
Cross-sectional area of rectus abdominis, external oblique, internal oblique and transversus abdominis in rest position.
1 day
Neuromuscular activity (mV)
Time Frame: 1 day
Neuromuscular activity (mV) of rectus abdominis, external oblique and internal oblique + transversus abdominis in rest position.
1 day
Inter-rectus distance (mm) during an hypopressive exercise
Time Frame: 1 day
Inter-rectus distance (mm) during an hypopressive exercise performance in supine position.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alcala

Investigators

  • Study Director: Maria Torres, PhD, University of Alcala

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Actual)

January 8, 2018

Study Completion (Actual)

May 6, 2019

Study Registration Dates

First Submitted

January 25, 2018

First Submitted That Met QC Criteria

February 1, 2018

First Posted (Actual)

February 8, 2018

Study Record Updates

Last Update Posted (Actual)

May 7, 2019

Last Update Submitted That Met QC Criteria

May 6, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BAM2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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