Education by animated training video
BehavioralTraining performed by watching an animated educational video.
NCT Number: NCT02427854
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.
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Interventional
Not applicable
Palestinian Medical Complex, Ramallah, West Bank, Palestinian Territories
The main aim is to study the incidence of major delivery complications and perineal injuries during vaginal delivery in Palestine. A manual support technique of perineum will be introduced.
The steps of observation, training and interventions in this study:
Education in diagnosis and repair of perineal injuries and implementation of system to register data.
Data-registration baseline.
First part:
In all participating hospitals, the training in hands-on manual perineal protection will be communicated by animated instruction accessible on tablet computers and smart phones. The information and instructions how to perform the manual perineal protection is transferred for the users by instruction video showing the method as an animation with voice-over in Arabic and English. All 6 hospitals implement this intervention simultaneously.
Second part, the stepped wedge approach:
After one month the first hospitals starts with the traditional bedside hands-on training of the midwives and physicians. Norwegian midwives and obstetricians support this training. The traditional bedside training then starts stepwise in the 6 hospitals, one month after each other, in a stepped wedge model.
There will be a one year observational period where all data is collected.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Training performed by watching an animated educational video.
Training performed as a traditional bedside training supported by a trainer in person.
Time frame: 24 months
All degrees of perineal injuries, including episiotomies, before and after intervention (education of the labour room staff)
Time frame: 24 months
Severe maternal complications during labor and delivery, such as excessive bleeding, uterine rupture, infections, seizures.
Time frame: 24 months
Effect of education on the anatomy of female pelvic floor, and a course on repair of injuries.
Time frame: 24 months
Adverse fetal outcome Morbidity and mortality of the fetus/newborn. Number of fetuses.
Time frame: 24 months
Maternal pre-labor co-morbidity before pregnancy, during pregnancy and during delivery, such as diabetes, epilepsy, anemia, hypertensive conditions, medication.
Time frame: 24 months
Duration of delivery
Time frame: 24 months
Obstetric intervention during delivery
Time frame: 24 months
Operative delivery
Oslo University Hospital
Other
Can Perineal Tears and Obstetric Anal Sphincter Injuries in Palestine be Prevented? A Study of Two Different Interventions
Acronym: PPS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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