Clinical Trials Logo

Clinical Trial Summary

The main purpose of the study is to evaluate the effectiveness and safety of the impedance spectroscopy device prototype in detection of anal sphincter injuries in women in the early postpartum period. The study is prospective. The study group comprises 24 patients; included in it 6-8 weeks after natural delivery. The planned participation of each patient in the study is up to 4 weeks and three visits will take place at that time.

After obtaining written consent, at the screening visit (V0) each patient will undergo a physical examination, blood samples for laboratory tests and stool samples for calprotectin concentration assessment will be collected.

On the second visit (V1), after the final verification of inclusion/exclusion criteria, impedance spectroscopy using tested device will be performed in each patient, the electrical impedance of pelvic floor muscles will be measured and the degree of anal sphincter damage will be evaluated. Full gynecological and proctological examination (including a gynecological speculum, two-handed examination, rectal examination and anoscopy) will be carried out.

On the third visit (V2), two reference diagnostic tests (with evidenced effectiveness and safety), transanal ultrasonography and anorectal manometry, will be conducted. The collected data will be used to select the optimal therapeutic method for each participant individually.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03769792
Study type Interventional
Source OASIS Diagnostics S.A.
Contact
Status Completed
Phase N/A
Start date February 4, 2019
Completion date December 23, 2019

See also
  Status Clinical Trial Phase
Completed NCT04047433 - The Occurrence of Single Nucleotide Polymorphism Among Women Who Experienced Obstetric Anal Sphincter Injury N/A
Completed NCT00565643 - Seprafilm® Adhesion Barrier and Cesarean Delivery Phase 4
Active, not recruiting NCT03591159 - The Effect of Membrane Sweeping on the Delivery Time and the Need of Induction in Term Pregnancy N/A
Completed NCT01905644 - Verifying Post-delivery Anal Sphincter Integrity Using Perineal Ultrasound: Impact on Immediate Care N/A
Completed NCT02870712 - Randomized Controlled Trial of the Effectiveness of Perineal Pain and Security of the Suture Led by the Result of Hemostasis Versus Manual Compression Routine Suture Perineal Tears of First Degree During Childbirth N/A
Completed NCT02185625 - Reduction of Adverse Pregnancy Outcomes With a Smartphone Application in Ghana N/A
Completed NCT00665405 - Atelectasis During Delivery - Comparing Cesarian (c) -Section and Labor N/A
Not yet recruiting NCT05763537 - Understanding the Role of Doulas in Supporting People With PMADs N/A
Recruiting NCT03178461 - The Effect of Warmed Parenteral Fluids During Delivery N/A
Completed NCT00379327 - Acupuncture for Promotion of Timely Delivery Phase 3
Completed NCT00127361 - Study of Having a Female Friend as Labor Support N/A
Terminated NCT02814344 - Comparative Study of the Propagation of Uterine Electrical Activity (EHG) in Pregnant Women During Pregnancy and During Labour
Completed NCT01174342 - Effect of Child Delivery on Intraocular Pressure N/A