Ongoing Clinical Trials for Perineal Injury
There are currently 3 clinical trials investigating different approaches to managing perineal injuries that occur during childbirth. These studies are exploring pain management options during repair procedures, sedation methods for patient comfort, and antibiotic use to prevent infections. The trials are being conducted in Spain, Sweden, and Denmark.
Clinical trial locations
- Denmark
- Spain
- Sweden
Comparing Lidocaine-Prilocaine Cream and Lidocaine Injection for First-Degree Perineal Tear Repair in Women
This study, conducted in Spain, is examining different ways to manage pain when repairing first-degree tears that happen during childbirth. First-degree tears are small tears in the skin and tissue between the vagina and anus.
Who can participate: Women aged 18 or older who have just had a single vaginal birth at 37 weeks or more of pregnancy and have a first-degree tear that needs stitching.
Who cannot participate: Women who are allergic to lidocaine, have other medical conditions that could interfere with the study, are taking medications that might interact with lidocaine, have infections or skin problems in the affected area, have had severe reactions to numbing medicines in the past, or are already participating in another clinical trial.
What the study is testing: The trial compares two different pain relief methods. One group receives EMLA cream, which contains lidocaine and prilocaine and is applied directly to the skin. The other group receives an injection of lidocaine solution to numb the area. Researchers will monitor pain levels during the repair and for two hours after delivery using a pain scale.
Investigational treatments: The study uses lidocaine-prilocaine cream (EMLA), which is applied to the skin to block nerve signals and reduce pain, and 2% lidocaine injection, which is injected into the tear area to quickly numb it and block pain signals.
Study on Patient-Controlled Sedation with Propofol for Women Undergoing Repair of Obstetric Perineal Tears Using Ropivacaine, Lidocaine, and Mepivacaine
This Swedish trial is investigating whether giving women control over their own sedation during tear repair can improve their overall experience and reduce pain and discomfort.
Who can participate: Adult women (18 years or older) who have first or second-degree tears requiring examination and repair, and who have provided signed consent after understanding the study information.
Who cannot participate: Men, women under 18 years old, pregnant women, those with allergies to propofol, women with a history of severe reactions to anesthesia, those with certain heart, lung, or liver conditions, and women already participating in another clinical trial.
What the study is testing: The trial examines whether adding patient-controlled sedation with propofol to the standard pudendal nerve block (a type of local anesthesia) can reduce pain and improve comfort during the repair procedure. Participants use a device that lets them control their sedation level as needed. The study also monitors factors such as anxiety before the procedure, repair time, pain levels, and the ability to have skin-to-skin contact with the baby during repair.
Investigational treatments: Propofol is given through a vein to help patients relax and feel less pain, with patients controlling how much they receive. The pudendal nerve block is used as part of standard care to numb the pelvic area. Other local anesthetics used include ropivacaine, lidocaine, and mepivacaine.
Study on Amoxicillin and Clavulanic Acid to Prevent Infection in Women with Obstetric Perineal Tear
This Danish study is investigating whether taking antibiotics after a tear during childbirth can help prevent infections and wound complications.
Who can participate: Women over 18 years old who speak and read Danish, are mentally capable of giving informed consent, and have had a second-degree tear or episiotomy (a surgical cut) of the perineum after vaginal delivery that was stitched at Herlev Hospital.
Who cannot participate: Women without a tear, men, women outside the specified age range, and individuals considered part of vulnerable populations who may have limited ability to give informed consent.
What the study is testing: The trial compares the effects of oral antibiotics (Bioclavid) to a placebo (inactive substance) to see if the antibiotics can reduce the risk of infection and help wounds heal better. Participants are randomly assigned to receive either the antibiotics or placebo in a double-blind design, meaning neither participants nor researchers know who receives which treatment. The study monitors for infections, wound separation, and other complications such as pain, incontinence, pelvic prolapse, and sexual dysfunction at one week and one year after treatment.
Investigational treatments: The antibiotic being tested is a combination of amoxicillin and clavulanic acid (Bioclavid 500 mg/125 mg), taken orally in three doses. These antibiotics work by stopping the growth of bacteria, which can reduce infection risk and promote proper wound healing.
Summary
These three clinical trials address different aspects of managing perineal injuries during childbirth. The studies are geographically diverse, with one trial each in Spain, Sweden, and Denmark. The research focuses on three main areas: pain management during repair procedures, patient comfort through controlled sedation, and infection prevention through antibiotic treatment.
The Spanish trial specifically targets first-degree tears and compares topical versus injectable pain relief methods. The Swedish study investigates patient empowerment through self-controlled sedation for first and second-degree tears, while the Danish trial focuses on preventing complications in second-degree tears through antibiotic treatment. Together, these trials represent a comprehensive approach to improving outcomes and experiences for women experiencing perineal injuries during childbirth.
