Palestinian Perineum and Birth Complication Study (PPS)

November 24, 2023 updated by: Erik Fosse, Oslo University Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

  1. 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.
  2. To assess the present treatment of obstetric anal sphincter tears in Palestine.
  3. 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.
  4. 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.
  5. To compare results between the two different training methods.
  6. 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:

  1. Intervention 1 (1 month):

    Education in diagnosis and repair of perineal injuries and implementation of system to register data.

  2. Observation 1 (6 months):

    Data-registration baseline.

  3. 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.

  4. Observation 2 (12 months):

There will be a one year observational period where all data is collected.

Study Type

Interventional

Enrollment (Actual)

51041

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Palestinian Territory, occupied
      • Gaza, Palestinian Territory, occupied
        • AL Aqsa
      • Gaza City, Palestinian Territory, occupied
        • Shift
      • Hebron, Palestinian Territory, occupied
        • Hebron
    • West Bank
      • Ramallah, West Bank, Palestinian Territory, occupied
        • Palestinian Medical Complex

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of major delivery complications
Time Frame: 24 months
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
Time Frame: 24 months
Effect of education on the anatomy of female pelvic floor, and a course on repair of injuries.
24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months
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.
24 months
Duration of delivery laboring women as a Measure of Safety and Tolerability
Time Frame: 24 months
Duration of delivery
24 months
Number of Participants with obstetric intervention among laboring women in Palestine
Time Frame: 24 months
Obstetric intervention during delivery
24 months
Number of Participants with operative deliveries among laboring women in Palestine
Time Frame: 24 months
Operative delivery
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

University of Oslo
University of Birmingham
Croydon University Hospital
Birzeit University Palestine

Investigators

  • Study Director: Åse Vikanes, PhD, Oslo University Hospital
  • Principal Investigator: Erik Fosse, PhD, Oslo University Hospital, University of Oslo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

March 9, 2015

First Submitted That Met QC Criteria

April 27, 2015

First Posted (Estimated)

April 28, 2015

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 24, 2023

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/1727

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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