Palestinian Perineum and Birth Complication Study

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.

Conditions

• Complication of Labor and Delivery

Interventions

BEHAVIORAL

Education by animated training video

Training performed by watching an animated educational video.

PROCEDURE

Interactive hands-on bedside training

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

Sponsors & Collaborators

• Croydon University Hospital

  collaborator OTHER

• University of Oslo

  collaborator OTHER

• Birzeit University Palestine

  collaborator UNKNOWN

• University of Birmingham

  collaborator OTHER

• Oslo University Hospital

  lead OTHER

Principal Investigators

• Åse Vikanes, PhD · Oslo University Hospital

• Erik Fosse, PhD · Oslo University Hospital, University of Oslo

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

CROSSOVER

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-02-28

Primary Completion

2017-12-31

Completion

2018-12-31

Countries

• Palestinian Territories

Study Locations