Impedance Spectroscopy in Detection of Obstetric Anal Sphincter Injuries

Status Completed

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

Clinical Trial Details

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

View Details

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