Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04960800
Other study ID # 101944102
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2021
Est. completion date December 2023

Study information

Verified date July 2021
Source University of Bergen
Contact Nina- Margrethe Theodorsen, MSc
Phone 004792483509
Email nina-margrethe.theodorsen@uib.no
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Diastasis Rectus abdominis is a common condition in pregnant and postpartum women, where the connective tissue between the two muscle bellies of the rectus abdominis muscle is stretched and weakened, causing an increased inter-rectus distance. Treatment of this condition aim to reduce the inter-rectus distance, and conservative treatment including therapeutic exercise is the primary treatment of choice. To date, there is no generally accepted protocol of therapeutic exercises for this condition, and the evidence as to which exercise modality is the most effective and feasible in reducing the inter-rectus distance in women presenting with diastasis rectus abdominis is both sparse and weak. As this condition occur during the last two trimesters of pregnancy and as there is a paucity of high-quality studies on a pregnant population, investigators will conduct a randomized controlled trial on the effect of a specific exercise program during pregnancy on diastasis rectus abdominis. 100 pregnant women in gestation week 25 presenting with diastasis rectus abdominis of ≥ 28 mm will be included. Participants will be allocated to either an intervention group or a control group by block randomization. The intervention group will participate in a 12-week specific exercise program, consisting of two group sessions and two self-managed sessions weekly. The control group will not participate in any exercise intervention; however, participants will be recommended to follow national guidelines for general exercise during pregnancy. Participants will be assessed prior to intervention, post intervention at gestation week 37, and 6 weeks, 6 and 12 months postpartum. The primary outcome measure will be change in the inter-rectus distance in mm, measured by two-dimensional ultrasonography.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - healthy pregnant women - in gestation week 25 - presenting with an inter-rectus distance of 28 mm or more at the level of the umbilicus, and/or 2 cm above and below the umbilicus at rest on initial assessment. Participants presenting with a protrusion along the Linea Alba will also be included, even if they do not meet the inclusion criteria with an inter-rectus distance of 28 mm or more - Both primi- and multigravida women will be included, and there will be no limitations on number of fetuses Exclusion Criteria: - pregnancies where exercise is contraindicated - serious illnesses regarding both mother and fetus - inability to understand Scandinavian languages - failure to complete and present an informed consent form - presence of chronic physical or mental illness incompatible with the intervention Exclusion criteria during the study period is stillbirth or premature birth before gestation week 37; onset of serious illnesses regarding both mother and foetus; and pregnancies where exercise is contraindicated

Study Design


Intervention

Other:
Specific exercises
Specific exercises which aims to contract the recti abdominis combined with functional exercises with the aim to contract all the layers of the anterior abdominal wall. Strengthening dosage will be applied with 3 sets, containing between 8 and 12 repetitions of maximal load.

Locations

Country Name City State
Norway University of Bergen Bergen

Sponsors (2)

Lead Sponsor Collaborator
University of Bergen Norwegian Fund for Postgraduate Training in Physiotherapy

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary outcome measure will be change in inter-rectus distance in mm, measured by two-dimensional ultrasonography. The inter-rectus distance is the distance between the two muscle bulks of the rectus abdominis muscle. As the two muscle bulks are connected through the connective tissue Linea Alba, the inter-rectus distance is equivalent to the width of the line alba.The inter-rectus distance is measured 2 cm above and 2 cm below the umbilicus. Images of the inter-rectus distance is taken using 2-dimensional ultrasound, and measured using the free Microdicom software. Measurements will be done in mm. All participants will be assessed prior to intervention start in gestation week 27. They will then be reassessed at end of the intervention period at gestation week 37. Assessments will also be done 6 weeks, 6 and 12 months postpartum.
See also
  Status Clinical Trial Phase
Completed NCT05017974 - Research on Improving Sleep During Pregnancy N/A
Completed NCT03284515 - Vaccination In Pregnancy Gene Signature: VIP Signature Study
Recruiting NCT05969795 - Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support Phase 1
Recruiting NCT06051201 - Innovation for Small-scale Experiments: ReceptIVFity Test N/A
Recruiting NCT04828382 - Prospective Study of Pregnancy in Women With Cystic Fibrosis
Enrolling by invitation NCT04527926 - STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy N/A
Recruiting NCT04278651 - Early Antenatal Support for Iron Deficiency Anemia Phase 4
Recruiting NCT04405700 - Measuring Adverse Pregnancy and Newborn Congenital Outcomes
Recruiting NCT06258902 - Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
Completed NCT05487196 - Effectiveness of Clonidine, Dexmedetomidine, and Fentanyl Adjuncts for Labor Epidural Analgesia Phase 2
Completed NCT03750968 - Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects Phase 2
Enrolling by invitation NCT06127277 - Next4You: A Fully Mobile Relationships Based Program for Youth in Foster Care N/A
Completed NCT05897697 - Assessing Women's Preferences for Postpartum Thromboprophylaxis: the Prefer-Postpartum Study
Recruiting NCT05899101 - The Impact of Opioid and Cannabis Exposure on Fetal Growth
Completed NCT05502510 - Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
Completed NCT04296396 - Opioid Prescription After Cesarean Trial Phase 3
Not yet recruiting NCT06069869 - Multiple Micronutrient Supplementation (MMS) Iron Dose Acceptability Crossover Trial Phase 3
Not yet recruiting NCT06069856 - Multiple Micronutrient Supplementation (MMS) IFA- Iron Dose Acceptability Crossover Trial Phase 3
Not yet recruiting NCT06079918 - Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania Phase 3
Not yet recruiting NCT06163651 - Evaluating a One-Year Version of the Parent-Child Assistance Program N/A