Palestinian Perineum and Birth Complication Study (PPS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02427854|
Recruitment Status : Unknown
Verified February 2017 by Erik Fosse, Oslo University Hospital.
Recruitment status was: Recruiting
First Posted : April 28, 2015
Last Update Posted : March 1, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Complication of Labor and Delivery||Behavioral: Education by animated training video Procedure: Interactive hands-on bedside training||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70000 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Can Perineal Tears and Obstetric Anal Sphincter Injuries in Palestine be Prevented? A Study of Two Different Interventions|
|Study Start Date :||February 2015|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2018|
No Intervention: No training
Incidence of obstetric perineal injuries in the participating hospitals before implementation of the manual perineal protection method.
Active Comparator: Education by animated training video
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
Training performed by watching an animated educational video.
Active Comparator: Interactive hands on bedside training
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
Training performed as a traditional bedside training supported by a trainer in person.
- Incidence of obstetric perineal injuries [ Time Frame: 24 months ]All degrees of perineal injuries, including episiotomies, before and after intervention (education of the labour room staff)
- Occurrence of major delivery complications [ Time Frame: 24 months ]Severe maternal complications during labor and delivery, such as excessive bleeding, uterine rupture, infections, seizures.
- Occurrence of perineal injuries after education of the staff on diagnostics and repair [ Time Frame: 24 months ]Effect of education on the anatomy of female pelvic floor, and a course on repair of injuries.
- Number of Participants with Adverse fetal outcome as a Measure of Safety and Tolerability [ Time Frame: 24 months ]Adverse fetal outcome Morbidity and mortality of the fetus/newborn. Number of fetuses.
- Number of participants with chronic diseases among delivering women in Palestine [ Time Frame: 24 months ]Maternal pre-labor co-morbidity before pregnancy, during pregnancy and during delivery, such as diabetes, epilepsy, anemia, hypertensive conditions, medication.
- Duration of delivery laboring women as a Measure of Safety and Tolerability [ Time Frame: 24 months ]Duration of delivery
- Number of Participants with obstetric intervention among laboring women in Palestine [ Time Frame: 24 months ]Obstetric intervention during delivery
- Number of Participants with operative deliveries among laboring women in Palestine [ Time Frame: 24 months ]Operative delivery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02427854
|Contact: Erik Fosse, PhD||+47 email@example.com|
|Contact: Åse Vikanes, PhD||+47 firstname.lastname@example.org|
|Palestinian Territory, occupied|
|Palestinian Medical Complex||Recruiting|
|Ramallah, West Bank, Palestinian Territory, occupied|
|Gaza City, Palestinian Territory, occupied|
|Gaza, Palestinian Territory, occupied|
|Hebron, Palestinian Territory, occupied|
|Study Director:||Åse Vikanes, PhD||Oslo University Hospital|
|Principal Investigator:||Erik Fosse, PhD||Oslo University Hospital, University of Oslo|