Complication of Labor and DeliveryPPSNCT02427854
Palestinian Perineum and Birth Complication Study
A study testing Education by animated training video and Interactive hands-on bedside training in people with Complication of Labor and Delivery, run by Oslo University Hospital at 4 sites in Palestinian Territories.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Complication of Labor and Delivery
- What is being tested?
- Education by animated training video and Interactive hands-on bedside training
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51,041 participants
- Where
- 4 sitesPalestinian Territories
- Study dates
- Feb 2015to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- no exclusion criteria, the study aim is the education of the staff, and hospitals are compared as units.
Trial locations and contacts
4 sites in 1 country.
Palestinian Territories4 sites
AL Aqsa
Gaza
Shift
Gaza
Hebron
Hebron
Palestinian Medical Complex
Ramallah, West Bank
About this study
Official title: 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.
Read more
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.
Read the 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.
- 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.
- Conditions
- Complication of Labor and Delivery
- Being tested
- Education by animated training video, Interactive hands-on bedside training
- Keywords
- Major delivery complications, Perineal injuries, episiotomy
- Medical subject headings
- Obstetric Labor Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education by animated training videoBehavioural
Training performed by watching an animated educational video.
Interactive hands-on bedside trainingProcedure or surgery
Training performed as a traditional bedside training supported by a trainer in person.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Education by animated training video |
| 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. Receives: Procedure: Interactive hands-on bedside training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of obstetric perineal injuries
All degrees of perineal injuries, including episiotomies, before and after intervention (education of the labour room staff)
Measured: 24 months
Secondary outcomes (2)
Occurrence of major delivery complications
Severe maternal complications during labor and delivery, such as excessive bleeding, uterine rupture, infections, seizures.
Measured: 24 months
Occurrence of perineal injuries after education of the staff on diagnostics and repair
Effect of education on the anatomy of female pelvic floor, and a course on repair of injuries.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completion31 Dec 2017
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Complication of Labor and DeliveryStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 51,041 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Croydon University Hospital, University of Oslo, Birzeit University Palestine, University of Birmingham
- Responsible party
- Principal investigator, Erik Fosse, Oslo University Hospital
- Investigators
- Åse Vikanes, PhD, Study director, Oslo University HospitalErik Fosse, PhD, Principal investigator, Oslo University Hospital, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427854
- Sponsor's protocol ID
- 2014/1727
- Acronym
- PPS
- Status last verified
- Feb 2017
- First submitted
- 9 Mar 2015
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 18448735Laine 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.
PubMed 19482405Laine 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.
PubMed 23075573Hals 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.
PubMed 20859154Raisanen 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.
PubMed 23955189Raisanen 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.
PubMed 19852569Laine 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.
PubMed 23034015Stedenfeldt 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.
PubMed 23682573Raisanen 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.
PubMed 21182773Raisanen 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.
PubMed 25004348Raisanen 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.
PubMed 24938307Al-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.
PubMed 20236103Zimmo 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.
PubMed 36461037Hassan 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.
PubMed 31807087Ali-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.
PubMed 30510580
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Perineal Tears and Obstetric Anal Sphincter Injuries in Palestine be Prevented? A Study of Two Different Interventions
- ClinicalTrials.gov ID
- NCT02427854
- Acronym / sponsor ID
- PPS / 2014/1727
- Conditions
- Complication of Labor and Delivery
- Keywords
- Major delivery complications, Perineal injuries, episiotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51,041 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Croydon University Hospital, University of Oslo, Birzeit University Palestine, University of Birmingham
- Study start
- Feb 2015
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 28 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Education by animated training videoIncidence 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 | Procedure: Interactive hands-on bedside trainingIncidence 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- no exclusion criteria, the study aim is the education of the staff, and hospitals are compared as units.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education by animated training videoTraining performed by watching an animated educational video. | Behavioural | Education by animated training video |
| Interactive hands-on bedside trainingTraining performed as a traditional bedside training supported by a trainer in person. | Procedure or surgery | Interactive hands on bedside training |
Primary outcome
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)
2 secondary outcomes
Occurrence of major delivery complications
Time frame: 24 months
Occurrence of perineal injuries after education of the staff on diagnostics and repair
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Background: PubMed 18448735Laine 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.
- Background: PubMed 19482405Laine 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.
- Background: PubMed 23075573Laine 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.
- Background: PubMed 20859154Hals 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.
- Background: PubMed 23955189Raisanen 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.
- Background: PubMed 19852569Raisanen 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.
- Background: PubMed 23034015Laine 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.
- Background: PubMed 23682573Stedenfeldt 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.
- Background: PubMed 21182773Raisanen 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.
- Background: PubMed 25004348Raisanen 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.
- Background: PubMed 24938307Raisanen 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.
- Background: PubMed 20236103Al-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Åse Vikanes, PhD study director
Oslo University Hospital
Erik Fosse, PhD principal investigator
Oslo University Hospital, University of Oslo
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education by animated training video and Interactive hands-on bedside training in people with Complication of Labor and Delivery, run by Oslo University Hospital at 4 sites in Palestinian Territories.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Palestinian Territories. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of obstetric perineal injuries (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02427854, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.