Clinical trial NCT02427854: Palestinian Perineum and Birth Complication Study
Official title: Can Perineal Tears and Obstetric Anal Sphincter Injuries in Palestine be Prevented? A Study of Two Different Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complication of Labor and Delivery
Keywords: Major delivery complications
Perineal injuries
episiotomy
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Croydon University Hospital
name: University of Oslo
name: Birzeit University Palestine
name: University of Birmingham
First posted: 2015-04-28
Enrollment: 51041
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: Incidence of obstetric perineal injuries
timeFrame: 24 months
Secondary outcomes:
measure: Occurrence of major delivery complications
timeFrame: 24 months
measure: Occurrence of perineal injuries after education of the staff on diagnostics and repair
timeFrame: 24 months
Other outcomes:
measure: Number of Participants with Adverse fetal outcome as a Measure of Safety and Tolerability
timeFrame: 24 months
measure: Number of participants with chronic diseases among delivering women in Palestine
timeFrame: 24 months
measure: Duration of delivery laboring women as a Measure of Safety and Tolerability
timeFrame: 24 months
measure: Number of Participants with obstetric intervention among laboring women in Palestine
timeFrame: 24 months
measure: Number of Participants with operative deliveries among laboring women in Palestine
timeFrame: 24 months
Locations:
city: Ramallah
country: Palestinian Territory, occupied
facility: Palestinian Medical Complex
state: West Bank
city: Gaza City
country: Palestinian Territory, occupied
facility: Shift
city: Gaza
country: Palestinian Territory, occupied
facility: AL Aqsa
city: Hebron
country: Palestinian Territory, occupied
facility: Hebron
Study officials:
affiliation: Oslo University Hospital
name: Åse Vikanes, PhD
role: STUDY_DIRECTOR
affiliation: Oslo University Hospital, University of Oslo
name: Erik Fosse, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Laine K, Pirhonen T, Rolland R, Pirhonen J. Decreasing the incidence of anal sphincter tears during delivery. Obstet Gynecol. 2008 May;111(5):1053-7. doi: 10.1097/AOG.0b013e31816c4402.
citation: Laine K, Gissler M, Pirhonen J. Changing incidence of anal sphincter tears in four Nordic countries through the last decades. Eur J Obstet Gynecol Reprod Biol. 2009 Sep;146(1):71-5. doi: 10.1016/j.ejogrb.2009.04.033. Epub 2009 May 30.
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citation: Zimmo MW, Laine K, Hassan S, Bottcher B, Fosse E, Ali-Masri H, Zimmo K, Falk RS, Lieng M, Vikanes A. Exploring the impact of indication on variation in rates of intrapartum caesarean section in six Palestinian hospitals: a prospective cohort study. BMC Pregnancy Childbirth. 2022 Dec 2;22(1):892. doi: 10.1186/s12884-022-05196-8.
citation: Hassan S, Laine K, Fosse E, Abu-Rmeileh NM, Ali-Masri HY, Zimmo M, Zimmo K, Vikanes A, Ismail KM. Induction Of Labor Among Singleton Pregnancies In Six Palestinian Governmental Hospitals: A Population-Based Cohort Study. Int J Womens Health. 2019 Nov 7;11:597-605. doi: 10.2147/IJWH.S215781. eCollection 2019.
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citation: Zimmo MW, Laine K, Hassan S, Bottcher B, Fosse E, Ali-Masri H, Zimmo K, Sorum Falk R, Lieng M, Vikanes A. Caesarean section in Palestine using the Robson Ten Group Classification System: a population-based birth cohort study. BMJ Open. 2018 Oct 24;8(10):e022875. doi: 10.1136/bmjopen-2018-022875.
citation: Zimmo K, Laine K, Fosse E, Zimmo M, Ali-Masri H, Zucknick M, Vikanes A, Hassan S. Episiotomy practice in six Palestinian hospitals: a population-based cohort study among singleton vaginal births. BMJ Open. 2018 Jul 16;8(7):e021629. doi: 10.1136/bmjopen-2018-021629.
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citation: Ali-Masri H, Hassan S, Ismail K, Zimmo K, Zimmo M, Fosse E, Vikanes A, Laine K. Enhancing recognition of obstetric anal sphincter injuries in six maternity units in Palestine: an interventional quality improvement study. BMJ Open. 2018 Jun 19;8(6):e020983. doi: 10.1136/bmjopen-2017-020983.
citation: Zimmo M, Laine K, Hassan S, Fosse E, Lieng M, Ali-Masri H, Zimmo K, Anti M, Bottcher B, Sorum Falk R, Vikanes A. Differences in rates and odds for emergency caesarean section in six Palestinian hospitals: a population-based birth cohort study. BMJ Open. 2018 Mar 2;8(3):e019509. doi: 10.1136/bmjopen-2017-019509.
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citation: Zimmo K, Laine K, Vikanes A, Fosse E, Zimmo M, Ali H, Thakar R, Sultan AH, Hassan S. Diagnosis and repair of perineal injuries: knowledge before and after expert training-a multicentre observational study among Palestinian physicians and midwives. BMJ Open. 2017 Apr 7;7(4):e014183. doi: 10.1136/bmjopen-2016-014183.
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