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Palestinian Perineum and Birth Complication Study (PPS)

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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
Sponsor:
Collaborators:
Croydon University Hospital
University of Oslo
Birzeit University Palestine
University of Birmingham
Information provided by (Responsible Party):
Erik Fosse, Oslo University Hospital

Brief 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.


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70000 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Occurrence of major delivery complications [ Time Frame: 24 months ]
    Severe maternal complications during labor and delivery, such as excessive bleeding, uterine rupture, infections, seizures.

  2. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. Duration of delivery laboring women as a Measure of Safety and Tolerability [ Time Frame: 24 months ]
    Duration of delivery

  4. Number of Participants with obstetric intervention among laboring women in Palestine [ Time Frame: 24 months ]
    Obstetric intervention during delivery

  5. Number of Participants with operative deliveries among laboring women in Palestine [ Time Frame: 24 months ]
    Operative delivery



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Erik Fosse, PhD +47 23070116 erik.fosse@medisin.uio.no
Contact: Åse Vikanes, PhD +47 91318402 vikanes.se8@gmail.com

Locations
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Palestinian Territory, occupied
Palestinian Medical Complex Recruiting
Ramallah, West Bank, Palestinian Territory, occupied
Shift Recruiting
Gaza City, Palestinian Territory, occupied
AL Aqsa Recruiting
Gaza, Palestinian Territory, occupied
Hebron Recruiting
Hebron, Palestinian Territory, occupied
Sponsors and Collaborators
Oslo University Hospital
Croydon University Hospital
University of Oslo
Birzeit University Palestine
University of Birmingham
Investigators
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Study Director: Åse Vikanes, PhD Oslo University Hospital
Principal Investigator: Erik Fosse, PhD Oslo University Hospital, University of Oslo

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Erik Fosse, Professor, Head of Department, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02427854     History of Changes
Other Study ID Numbers: 2014/1727
First Posted: April 28, 2015    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017

Keywords provided by Erik Fosse, Oslo University Hospital:
Major delivery complications
Perineal injuries
episiotomy

Additional relevant MeSH terms:
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Obstetric Labor Complications
Pregnancy Complications