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Changes in Abdominal Muscles Performance in Postpartum Women.

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ClinicalTrials.gov Identifier: NCT03425916
Recruitment Status : Recruiting
First Posted : February 8, 2018
Last Update Posted : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
Beatriz Arranz Martin, University of Alcala

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.

Condition or disease Intervention/treatment
Recti Diastasis Pregnancy Related Other: Physical therapy intervention

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
Estimated Enrollment : 196 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Changes in Abdominal Muscles Performance and Inter-rectus Distance in Postpartum Women: an Ultrasonography and Electromyographic Study.
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : January 8, 2018
Estimated Study Completion Date : March 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care

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



Primary Outcome Measures :
  1. Inter-rectus distance (mm) [ Time Frame: 1 day ]
    Inter-rectus abdominis distance in mm in rest position.


Secondary Outcome Measures :
  1. Cross-sectional area (mm) [ Time Frame: 1 day ]
    Cross-sectional area of rectus abdominis, external oblique, internal oblique and transversus abdominis in rest position.

  2. Neuromuscular activity (mV) [ Time Frame: 1 day ]
    Neuromuscular activity (mV) of rectus abdominis, external oblique and internal oblique + transversus abdominis in rest position.

  3. Inter-rectus distance (mm) during an hypopressive exercise [ Time Frame: 1 day ]
    Inter-rectus distance (mm) during an hypopressive exercise performance in supine position.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03425916


Contacts
Contact: Beatriz Arranz, MSc +34616812005 beatriz.arranz@edu.uah.es
Contact: Maria Torres, PhD 918854828 ext 4828 fisioterapia.mujer@uah.es

Locations
Spain
Beatriz Arranz Martin Recruiting
Alcalá De Henares, Madrid, Spain, 28805
Contact: Beatriz Arranz, MSc    +34616812005    beatriz.arranz@edu.uah.es   
Contact: Maria Torres, PhD    918854828 ext 4828    fisioterapia.mujer@uah.es   
Sponsors and Collaborators
University of Alcala
Investigators
Study Director: Maria Torres, PhD University of Alcala

Responsible Party: Beatriz Arranz Martin, Physiotherapist, University of Alcala
ClinicalTrials.gov Identifier: NCT03425916     History of Changes
Other Study ID Numbers: BAM2018
First Posted: February 8, 2018    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Beatriz Arranz Martin, University of Alcala:
Hypopressive exercises
Ultrasonography