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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03425916
Other study ID # BAM2018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2017
Est. completion date May 6, 2019

Study information

Verified date May 2019
Source University of Alcala
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 196
Est. completion date May 6, 2019
Est. primary completion date January 8, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Spain Beatriz Arranz Martin Alcalá De Henares Madrid

Sponsors (1)

Lead Sponsor Collaborator
University of Alcala

Country where clinical trial is conducted

Spain, 

Outcome

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