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Completed

NCT Number: NCT02427854

Palestinian Perineum and Birth Complication Study

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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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Palestinian Medical Complex, Ramallah, West Bank, Palestinian Territories

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Education by animated training video

Behavioral

Training performed by watching an animated educational video.

Interactive hands-on bedside training

Procedure

Training performed as a traditional bedside training supported by a trainer in person.

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: PPS

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Apr 28, 2015
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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