Palestinian Perineum and Birth Complication Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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. To assess the incidence of perineal tears, episiotomies, obstetric anal sphincter injuries and major obstetric complications in Palestine in a multicenter study involving three hospitals on the West Bank and three hospitals in Gaza. To assess the present treatment of obstetric anal sphincter tears in Palestine. To study whether intervention with bed-side training of the hands-on the Norwegian-Finnish support technique reduce the incidence of obstetric anal sphincter tears. To study whether training by animated instructions of the same hands-on support technique, using smart phones or tablet computers, reduce the incidence of obstetric anal sphincter injuries. To compare results between the two different training methods. To study midwives' and doctors' attitudes towards hands-on training compared to training by animated instructions. The main aim is to assess the incidence of perineal injuries during vaginal delivery in Palestine, and to introduce a manual support technique of perineum. Norwegian intervention studies have shown that the incidence of obstetric anal sphincter injuries (OASIS) can be reduced by 40-70% by improving hands-on delivering techniques. The reduction was achieved by educating all staff on the delivery unit, implementing a new hands-on delivering technique. Some previous research has shown that non-interactive training by animated instructions or videos in emergency obstetric care, might be equally effective as conventional interactive hands-on training. However, the effectiveness of training by animated instructions compared to conventional training programs remains to be assessed properly. By performing a multicentre intervention study, the investigators will explore the effect of interactive hands-on training on the incidence of perineal injuries. Likewise the investigators will study effect of non-interactive training by animated instructions. Three hospitals on the West Bank (WB) and three in Gaza have accepted to participate. The investigators will also assess whether attitudes towards training methods influence the results. The steps of observation, training and interventions in this study: Intervention 1 (1 month): Education in diagnosis and repair of perineal injuries and implementation of system to register data. Observation 1 (6 months): Data-registration baseline. Intervention 2, (6 months): 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. Observation 2 (12 months): There will be a one year observational period where all data is collected.

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

Conditions
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Complication of Labor and Delivery

Intervention / Treatment
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* Behavioral: Education by animated training video
* Procedure: Interactive hands-on bedside training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all midwives and physicians working on labor ward in the participating hospitals. all women giving birth in the participating hospitals. both genders are included in the staff, and among the newborns Exclusion Criteria: no exclusion criteria, the study aim is the education of the staff, and hospitals are compared as units.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No training<br>Incidence of obstetric perineal injuries in the participating hospitals before implementation of the manual perineal protection method. | |
| Active Comparator: Education by animated training video<br>Incidence of obstetric perineal injuries in the participating hospitals, after the delivery unit staff has been educated and trained to a perineal support by an animated training video only. | Behavioral: Education by animated training video<br>* Training performed by watching an animated educational video.<br>|
| Active Comparator: Interactive hands on bedside training<br>Incidence of obstetric perineal injuries in the participating hospitals, after the delivery unit staff has been educated and trained to a perineal support by an animated training video and additionally by an interactive hands-on bedside training. | Procedure: Interactive hands-on bedside training<br>* Training performed as a traditional bedside training supported by a trainer in person.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of obstetric perineal injuries | All degrees of perineal injuries, including episiotomies, before and after intervention (education of the labour room staff) | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of major delivery complications | Severe maternal complications during labor and delivery, such as excessive bleeding, uterine rupture, infections, seizures. | 24 months | 
| Occurrence of perineal injuries after education of the staff on diagnostics and repair | Effect of education on the anatomy of female pelvic floor, and a course on repair of injuries. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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episiotomy, Major delivery complications, Perineal injuries