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| Name | Class |
|---|---|
| Croydon University Hospital | OTHER |
| University of Oslo | OTHER |
| Birzeit University Palestine | UNKNOWN |
| University of Birmingham |
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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No training | No Intervention | Incidence of obstetric perineal injuries in the participating hospitals before implementation of the manual perineal protection method. | |
| Education by animated training video | Active Comparator | 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. |
|
| Interactive hands on bedside training | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education by animated training video | Behavioral | Training performed by watching an animated educational video. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of obstetric perineal injuries | All degrees of perineal injuries, including episiotomies, before and after intervention (education of the labour room staff) | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of major delivery complications | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse fetal outcome as a Measure of Safety and Tolerability | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ã…se Vikanes, PhD | Oslo University Hospital | Study Director |
| Erik Fosse, PhD | Oslo University Hospital, University of Oslo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palestinian Medical Complex | Ramallah | West Bank | Palestinian Territories | |||
| AL Aqsa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18448735 | Background | 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. | |
| 19482405 | Background | 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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| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| OTHER |
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| Interactive hands-on bedside training | Procedure | Training performed as a traditional bedside training supported by a trainer in person. |
|
Effect of education on the anatomy of female pelvic floor, and a course on repair of injuries. |
| 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 | Duration of delivery | 24 months |
| Number of Participants with obstetric intervention among laboring women in Palestine | Obstetric intervention during delivery | 24 months |
| Number of Participants with operative deliveries among laboring women in Palestine | Operative delivery | 24 months |
| Gaza |
| Palestinian Territories |
| Shift | Gaza | Palestinian Territories |
| Hebron | Hebron | Palestinian Territories |
| 23075573 | Background | Laine K, Skjeldestad FE, Sandvik L, Staff AC. Incidence of obstetric anal sphincter injuries after training to protect the perineum: cohort study. BMJ Open. 2012 Oct 17;2(5):e001649. doi: 10.1136/bmjopen-2012-001649. Print 2012. |
| 20859154 | Background | Hals E, Oian P, Pirhonen T, Gissler M, Hjelle S, Nilsen EB, Severinsen AM, Solsletten C, Hartgill T, Pirhonen J. A multicenter interventional program to reduce the incidence of anal sphincter tears. Obstet Gynecol. 2010 Oct;116(4):901-908. doi: 10.1097/AOG.0b013e3181eda77a. |
| 23955189 | Background | Raisanen S, Cartwright R, Gissler M, Kramer MR, Laine K, Jouhki MR, Heinonen S. Changing associations of episiotomy and anal sphincter injury across risk strata: results of a population-based register study in Finland 2004-2011. BMJ Open. 2013 Aug 17;3(8):e003216. doi: 10.1136/bmjopen-2013-003216. |
| 19852569 | Background | Raisanen SH, Vehvilainen-Julkunen K, Gissler M, Heinonen S. Lateral episiotomy protects primiparous but not multiparous women from obstetric anal sphincter rupture. Acta Obstet Gynecol Scand. 2009;88(12):1365-72. doi: 10.3109/00016340903295626. |
| 23034015 | Background | Laine K, Rotvold W, Staff AC. Are obstetric anal sphincter ruptures preventable?-- large and consistent rupture rate variations between the Nordic countries and between delivery units in Norway. Acta Obstet Gynecol Scand. 2013 Jan;92(1):94-100. doi: 10.1111/aogs.12024. Epub 2012 Dec 5. |
| 23682573 | Background | Stedenfeldt M, Oian P, Gissler M, Blix E, Pirhonen J. Risk factors for obstetric anal sphincter injury after a successful multicentre interventional programme. BJOG. 2014 Jan;121(1):83-91. doi: 10.1111/1471-0528.12274. Epub 2013 May 20. |
| 21182773 | Background | Raisanen S, Vehvilainen-Julkunen K, Gissler M, Heinonen S. Up to seven-fold inter-hospital differences in obstetric anal sphincter injury rates- A birth register-based study in Finland. BMC Res Notes. 2010 Dec 23;3:345. doi: 10.1186/1756-0500-3-345. |
| 25004348 | Background | Raisanen S, Kancherla V, Kramer MR, Gissler M, Heinonen S. Placenta previa and the risk of delivering a small-for-gestational-age newborn. Obstet Gynecol. 2014 Aug;124(2 Pt 1):285-291. doi: 10.1097/AOG.0000000000000368. |
| 24938307 | Background | Raisanen S, Kancherla V, Gissler M, Kramer MR, Heinonen S. Adverse perinatal outcomes associated with moderate or severe maternal anaemia based on parity in Finland during 2006-10. Paediatr Perinat Epidemiol. 2014 Sep;28(5):372-80. doi: 10.1111/ppe.12134. Epub 2014 Jun 17. |
| 20236103 | Background | Al-Zirqi I, Stray-Pedersen B, Forsen L, Vangen S. Uterine rupture after previous caesarean section. BJOG. 2010 Jun;117(7):809-20. doi: 10.1111/j.1471-0528.2010.02533.x. Epub 2010 Mar 24. |
| 36461037 | Background | 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. |
| 31807087 | Background | 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. |
| 30510580 | Background | Ali-Masri HY, Hassan SJ, Zimmo KM, Zimmo MW, Ismail KMK, Fosse E, Alsalman H, Vikanes A, Laine K. Evaluation of Accuracy of Episiotomy Incision in a Governmental Maternity Unit in Palestine: An Observational Study. Obstet Gynecol Int. 2018 Oct 29;2018:6345497. doi: 10.1155/2018/6345497. eCollection 2018. |
| 30419884 | Background | Ali-Masri H, Hassan S, Fosse E, Zimmo KM, Zimmo M, Ismail KMK, Vikanes A, Laine K. Impact of electronic and blended learning programs for manual perineal support on incidence of obstetric anal sphincter injuries: a prospective interventional study. BMC Med Educ. 2018 Nov 12;18(1):258. doi: 10.1186/s12909-018-1363-3. |
| 30361403 | Background | 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. |
| 30012790 | Background | 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. |
| 30008080 | Background | Zimmo KM, Laine K, Fosse E, Zimmo M, Ali-Masri H, Bottcher B, Zucknick M, Vikanes A, Hassan S. Impact of animated instruction on tablets and hands-on training in applying bimanual perineal support on episiotomy rates: an intervention study. Int Urogynecol J. 2019 Aug;30(8):1343-1350. doi: 10.1007/s00192-018-3711-6. Epub 2018 Jul 14. |
| 29921684 | Background | 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. |
| 29500211 | Background | 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. |
| 28399841 | Background | Hassan S, Vikanes A, Laine K, Zimmo K, Zimmo M, Bjertness E, Fosse E. Building a research registry for studying birth complications and outcomes in six Palestinian governmental hospitals. BMC Pregnancy Childbirth. 2017 Apr 11;17(1):112. doi: 10.1186/s12884-017-1296-6. |
| 28389490 | Background | 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. |
| 28171679 | Background | Ali HY, Vikanes A, Anti M, Hassan S, Ismail KM, Zimmo K, Zimmo M, Fosse E, Laine K. Evaluation of an animated instructional video as a training tool for manual perineum support during vaginal delivery. Int J Gynaecol Obstet. 2017 May;137(2):213-219. doi: 10.1002/ijgo.12115. Epub 2017 Feb 27. |