CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 51,041 enrolled
Drug / intervention
Education by animated training video +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02427854
NCT02427854N/ACompleted

Can Perineal Tears and Obstetric Anal Sphincter Injuries in Palestine be Prevented? A Study of Two Different Interventions

Oslo University Hospital·interventional·Posted Apr 28, 2015·Updated Nov 29, 2023

In Brief

A clinical study evaluating Education by animated training video and Interactive hands-on bedside training for Complication of Labor and Delivery. Completed, enrolled 51,041 participants across 4 sites.

Detailed Summary

In this study the investigators want to assess complications associated to pregnancy and delivery, and interventions used during labor. Pregnancy and delivery related complications are a major health problem globally. Events during labor such as excessive bleeding, uterine rupture, emergency cesarean delivery; other instrumental deliveries and anesthesia problems are situations that potentially may lead to severe outcomes for the mother and child. Diabetes, anemia and hypertensive disorders may also complicate both the pregnancy and delivery. Between 60-80% of women delivering their first baby need suturing due to perineal tears (tears located to the area between the vagina and anus). Superficial perineal tears rarely cause long-term problems, but often lead to pain and discomfort immediately after birth. Deeper or severe perineal tears, involving the anal sphincter, may influence the woman's quality of life. This is mainly due to long-lasting pain, discomfort and sexual dysfunction, and the fact that obstetric anal sphincter tear is the main cause of anal incontinence. Recent clinical intervention studies have shown that the incidence of severe obstetric perineal tears may be reduced by 50-70% by introducing a bimanual support technique of the perineum. In these studies all midwives and gynecologists were trained in the bimanual support technique. When it comes to training in new medical techniques in general, some studies have shown that use of animated instructions on mobile phones may be a good alternative to the more traditional "hands-on" or "bedside" teaching methods. In a global perspective, it is important to study the efficacy of mobile units for transferring of new knowledge, especially for use in resource constrained settings.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPalestinian Territories

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 28, 2015
Enrollment StartFeb 1, 2015
Primary CompletionDec 31, 2017
Study CompletionDec 31, 2018
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 11.2 years ago

Interventions

Education by animated training videobehavioral

Training performed by watching an animated educational video.

Interactive hands-on bedside trainingprocedure

Training performed as a traditional bedside training supported by a trainer in person.