Anal Sphincter InjuryNCT05436171
Prevalence of Obstetric Anal Sphincter Injury With a Reducing Episiotomy Rate
An observational study of Anal Sphincter Injury, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Obstetric anal sphincter injury (OASIS) is a serious complication of a vaginal delivery. High proportion of women, 40-59%, suffer from faecal incontinence (FI) after this type of injury.1-3 OASIS and FI have a negative impact on women's quality of life.4 The rate of elective caesarean section at second birth was much… Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Anal Sphincter Injury
- How many people
- 6,700 participants
- Where
- 1 siteHong Kong
- Study dates
- 11 Aug 2022to 31 May 2023
- Phase
- Observational
- 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 18 to 99 years
- Women only
- Adult, Older adult
Study population: The target sample size will be about 67,000 women who had delivered in our unit from 2011 to 2021. Among them, it is expected that 75-80% had vaginal deliveries, either normal vaginal delivery or instrumental delivery. 53,600 will be recruited in study site.
Who may be able to join
- All deliveries conducted from 2011 to 2021 in Prince of Wales Hospital
Who cannot join
- Deliveries with Caesarean Section
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong
Hong Kong, 852
Yan Yan Lau, 5569 9272, yanyanlau@cuhk.edu.hk
About this study
Obstetric anal sphincter injury (OASIS) is a serious complication of a vaginal delivery. High proportion of women, 40-59%, suffer from faecal incontinence (FI) after this type of injury.1-3 OASIS and FI have a negative impact on women's quality of life.4 The rate of elective caesarean section at second birth was much higher in women with OASIS at first birth compared with women without the injury (adjusted odds ratio 18.3, 95% CI 16.4-20.4).5 Primiparity has an increased risk of OASIS (odds ratio (OR) 2.39-8.34).6,7 Other factors are macrosomia and instrumental vaginal delivery.6,7 The role of episiotomy on OASIS has also been widely studied but there are controversial results.
There were around 500-7000 deliveries at Prince of Wales Hospital annually. Among them, 50-55% was nulliparous women. About 65 -70% of women had normal vaginal delivery and another 5-10% had instrumental delivery. There was a change from 'routine episiotomy' to a more restrictive use of episiotomy in normal vaginal delivery during the last 10 years, with a reduction of rate of episiotomy from 90% to about 50% (from Dept.'s internal audit). The objective of this study is to evaluate the prevalence of OASIS in the era of a reduction of episiotomy.
Read the detailed description
Obstetric anal sphincter injury (OASIS) is a serious complication of a vaginal delivery. High proportion of women, 40-59%, suffer from faecal incontinence (FI) after this type of injury.1-3 OASIS and FI have a negative impact on women's quality of life.4 The rate of elective caesarean section at second birth was much higher in women with OASIS at first birth compared with women without the injury (adjusted odds ratio 18.3, 95% CI 16.4-20.4).5 Primiparity has an increased risk of OASIS (odds ratio (OR) 2.39-8.34).6,7 Other factors are macrosomia and instrumental vaginal delivery.6,7 The role of episiotomy on OASIS has also been widely studied but there are controversial results.
Episiotomy is a surgical enlargement of the vaginal orifice by an incision to the perineum during the last part of the second stage of labour or delivery.8 It is accepted that episiotomy facilitates delivery, prevents perineal lacerations and undue stretching of the pelvic floor.9 It is also believed that an episiotomy is easier to repair and heals better than a tear.10 Mediolateral episiotomy is the most frequently used type of episiotomy in Hong Kong. Some obstetric units perform episiotomy more liberally on a routine basis; while others adopt a more restrictive policy. Cochrane review identified eight randomized controlled trials (RCT) comparing routine episiotomy and restrictive episiotomy. 9,10-17 The restrictive use of episiotomy shows a lower risk of severe perineal trauma (relative risk (RR) 0.67, 95% CI 0.49-0.91), posterior perineal trauma (RR 0.88, 95% CI 0.84-0.92), need for suturing perineal trauma (RR 0.71, 95% CI 0.61-0.81), and healing complications at seven days (RR 0.69, 95% CI 0.56-0.85).13 No difference is shown in the incidence of major outcomes such as severe vaginal and perineal trauma (when both vaginal and perineal trauma are counted) nor in pain, dyspareunia or urinary incontinence. However, the restrictive use of episiotomy has an increased risk of anterior perineal trauma (RR 1.84, 95% CI 1.61-2.10).13 Therefore, it is not advised to practice routine episiotomy.
From a large retrospective studies conducted in Caucasian countries, mediolateral episiotomy has been shown to protect women from OASIS (OR 0.21-0.54). 6,7,18 Besides, there was also evidence showing that Asian women delivered in Caucasian countries with a low episiotomy rate had a high risk of OASIS.19,20 Furthermore, ethnical difference in pelvic connective tissues have been reported.21 And pregnant Chinese women has been shown to smaller genital hiatus and less mobility of pelvic organs than pregnant Caucasian women.22 This may lead to a different outcome in perineal trauma in Asian women with or without episiotomy during vaginal delivery.
There were around 500-7000 deliveries at Prince of Wales Hospital annually. Among them, 50-55% was nulliparous women. About 65-70% of women had normal vaginal delivery and another 5-10% had instrumental delivery. There was a change from 'routine episiotomy' to a more restrictive use of episiotomy in normal vaginal delivery during the last 10 years, with a reduction of rate of episiotomy from 90% to about 50% (from Dept.'s internal audit). The objective of this study is to evaluate the prevalence of OASIS in the era of a reduction of episiotomy. This would help inform obstetricians and midwives if there is any change in rate of OASIS and the relationship with episiotomy. The information would be useful to counsel our patients.
The protocol of current study complies with Declaration of Helsinki.
The HA CMS OBSCIS is the electronic system that have collected the demographic, pregnancy, delivery and postnatal data of pregnant women. The data was entered by midwives and obstetricians during all consultations and admission of delivery of all pregnant women.
In this study, the following information will be retrieved from the CMS OBSCIS database for all delivery conducted from 2011 to 2021.
- Demographic data: age, parity, body weight and height
- Past obstetric history (if any): mode of delivery, birthweight and sex of infant, use of episiotomy
- Delivery data: gestation at delivery, need of induction of labour, analgesics during labour, duration of labour, mode of delivery, use of episiotomy, any perineal tear, blood loss during delivery, need of transfusion, wound complication, duration of hospital stay; and infant's birthweight, sex and apgar score
- For women with OASIS: the method of repair, the symptom of pelvic floor disorders, such as faecal or flatal incontinence, urinary incontinence, symptoms of prolapse after the delivery.
- Conditions
- Anal Sphincter Injury
- Being tested
- No intervention
- Keywords
- Anal sphincter injury, Episiotomy, Prevalence, OASIS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| All deliveries conducted from 2011 to 2021 in Prince of Wales Hospital | All deliveries conducted from 2011 to 2021 in Prince of Wales Hospital
The target sample size will be about 67,000 women who had delivered in our unit from 2011 to 2021. Among them, it is expected that 75-80% had vaginal deliveries, either normal vaginal delivery or instrumental delivery. 53,600 will be recruited in study site. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of obstetric anal sphincter injury (third or fourth degree tear) detected clinically immediately after delivery
Prevalence of obstetric anal sphincter injury (third or fourth degree tear) detected clinically immediately after delivery
Measured: Immediately after delivery
Secondary outcomes (1)
The factors associated with OASIS
Linear regression will be used to assess the correlations between factors e.g. mode of delivery, episiotomy, perineal/vaginal tear, duration of labour, birthweight and OASIS. Univariate and multivariate analysis will be used to look for potential factors of OASIS.
Measured: Immediately after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start11 Aug 2022
- Primary completion31 May 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Anal Sphincter InjuryStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 6,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LAU Yan Yan, Chinese University of Hong Kong
- Investigators
- Yan Yan Lau, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436171
- Sponsor's protocol ID
- CRE 2022.259
- Status last verified
- Aug 2022
- First submitted
- 23 Jun 2022
- Last updated
- 15 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Undecided
Publications
Norderval S, Nsubuga D, Bjelke C, Frasunek J, Myklebust I, Vonen B. Anal incontinence after obstetric sphincter tears: incidence in a Norwegian county. Acta Obstet Gynecol Scand. 2004 Oct;83(10):989-94. doi: 10.1111/j.0001-6349.2004.00647.x.
PubMed 15453900Sultan AH, Kamm MA, Hudson CN, Bartram CI. Third degree obstetric anal sphincter tears: risk factors and outcome of primary repair. BMJ. 1994 Apr 2;308(6933):887-91. doi: 10.1136/bmj.308.6933.887.
PubMed 8173367Sangalli MR, Floris L, Faltin D, Weil A. Anal incontinence in women with third or fourth degree perineal tears and subsequent vaginal deliveries. Aust N Z J Obstet Gynaecol. 2000 Aug;40(3):244-8. doi: 10.1111/j.1479-828x.2000.tb03330.x.
PubMed 11065029Tucker J, Clifton V, Wilson A. Teetering near the edge; women's experiences of anal incontinence following obstetric anal sphincter injury: an interpretive phenomenological research study. Aust N Z J Obstet Gynaecol. 2014 Aug;54(4):377-81. doi: 10.1111/ajo.12230.
PubMed 25117190Edozien LC, Gurol-Urganci I, Cromwell DA, Adams EJ, Richmond DH, Mahmood TA, van der Meulen JH. Impact of third- and fourth-degree perineal tears at first birth on subsequent pregnancy outcomes: a cohort study. BJOG. 2014 Dec;121(13):1695-703. doi: 10.1111/1471-0528.12886. Epub 2014 Jul 9.
PubMed 25040835de Leeuw JW, Struijk PC, Vierhout ME, Wallenburg HC. Risk factors for third degree perineal ruptures during delivery. BJOG. 2001 Apr;108(4):383-7. doi: 10.1111/j.1471-0528.2001.00090.x.
PubMed 11305545Aukee P, Sundstrom H, Kairaluoma MV. The role of mediolateral episiotomy during labour: analysis of risk factors for obstetric anal sphincter tears. Acta Obstet Gynecol Scand. 2006;85(7):856-60. doi: 10.1080/00016340500408283.
PubMed 16817086Thacker SB, Banta HD. Benefits and risks of episiotomy: an interpretative review of the English language literature, 1860-1980. Obstet Gynecol Surv. 1983 Jun;38(6):322-38.
PubMed 6346168Harrison RF, Brennan M, North PM, Reed JV, Wickham EA. Is routine episiotomy necessary? Br Med J (Clin Res Ed). 1984 Jun 30;288(6435):1971-5. doi: 10.1136/bmj.288.6435.1971.
PubMed 6428627House MJ, Cario G, Jones MH. Episiotomy and the perineum: a random controlled trial. J Obstet Gynaecol 1986;7:107-110
Klein MC, Gauthier RJ, Jorgensen SH, Robbins JM, Kaczorowski J, Johnson B, Corriveau M, Westreich R, Waghorn K, Gelfand MM, et al. Does episiotomy prevent perineal trauma and pelvic floor relaxation? Online J Curr Clin Trials. 1992 Jul 1;Doc No 10:[6019 words; 65 paragraphs]. doi: 10.1097/00006254-199404000-00008.
PubMed 1343606Rodriguez A, Arenas EA, Osorio AL, Mendez O, Zuleta JJ. Selective vs routine midline episiotomy for the prevention of third- or fourth-degree lacerations in nulliparous women. Am J Obstet Gynecol. 2008 Mar;198(3):285.e1-4. doi: 10.1016/j.ajog.2007.11.007. Epub 2008 Jan 25.
PubMed 18221925Carroli G, Mignini L. Episiotomy for vaginal birth. Cochrane Database Syst Rev. 2009 Jan 21;(1):CD000081. doi: 10.1002/14651858.CD000081.pub2.
PubMed 19160176Routine vs selective episiotomy: a randomised controlled trial. Argentine Episiotomy Trial Collaborative Group. Lancet. 1993 Dec 18-25;342(8886-8887):1517-8.
PubMed 7902901Dannecker C, Hillemanns P, Strauss A, Hasbargen U, Hepp H, Anthuber C. Episiotomy and perineal tears presumed to be imminent: randomized controlled trial. Acta Obstet Gynecol Scand. 2004 Apr;83(4):364-8. doi: 10.1111/j.0001-6349.2004.00366.x.
PubMed 15005784
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Obstetric Anal Sphincter Injury With a Reducing Episiotomy Rate
- ClinicalTrials.gov ID
- NCT05436171
- Acronym / sponsor ID
- CRE 2022.259
- Conditions
- Anal Sphincter Injury
- Keywords
- Anal sphincter injury, Episiotomy, Prevalence, OASIS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,700 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 29 Jun 2022 (actual)
- 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.
Obstetric anal sphincter injury (OASIS) is a serious complication of a vaginal delivery. High proportion of women, 40-59%, suffer from faecal incontinence (FI) after this type of injury.1-3 OASIS and FI have a negative impact on women's quality of life.4 The rate of elective caesarean section at second birth was much higher in women with OASIS at first birth compared with women without the injury (adjusted odds ratio 18.3, 95% CI 16.4-20.4).5 Primiparity has an increased risk of OASIS (odds ratio (OR) 2.39-8.34).6,7 Other factors are macrosomia and instrumental vaginal delivery.6,7 The role of episiotomy on OASIS has also been widely studied but there are controversial results.
There were around 500-7000 deliveries at Prince of Wales Hospital annually. Among them, 50-55% was nulliparous women. About 65 -70% of women had normal vaginal delivery and another 5-10% had instrumental delivery. There was a change from 'routine episiotomy' to a more restrictive use of episiotomy in normal vaginal delivery during the last 10 years, with a reduction of rate of episiotomy from 90% to about 50% (from Dept.'s internal audit). The objective of this study is to evaluate the prevalence of OASIS in the era of a reduction of episiotomy.
Detailed description
Obstetric anal sphincter injury (OASIS) is a serious complication of a vaginal delivery. High proportion of women, 40-59%, suffer from faecal incontinence (FI) after this type of injury.1-3 OASIS and FI have a negative impact on women's quality of life.4 The rate of elective caesarean section at second birth was much higher in women with OASIS at first birth compared with women without the injury (adjusted odds ratio 18.3, 95% CI 16.4-20.4).5 Primiparity has an increased risk of OASIS (odds ratio (OR) 2.39-8.34).6,7 Other factors are macrosomia and instrumental vaginal delivery.6,7 The role of episiotomy on OASIS has also been widely studied but there are controversial results.
Episiotomy is a surgical enlargement of the vaginal orifice by an incision to the perineum during the last part of the second stage of labour or delivery.8 It is accepted that episiotomy facilitates delivery, prevents perineal lacerations and undue stretching of the pelvic floor.9 It is also believed that an episiotomy is easier to repair and heals better than a tear.10 Mediolateral episiotomy is the most frequently used type of episiotomy in Hong Kong. Some obstetric units perform episiotomy more liberally on a routine basis; while others adopt a more restrictive policy. Cochrane review identified eight randomized controlled trials (RCT) comparing routine episiotomy and restrictive episiotomy. 9,10-17 The restrictive use of episiotomy shows a lower risk of severe perineal trauma (relative risk (RR) 0.67, 95% CI 0.49-0.91), posterior perineal trauma (RR 0.88, 95% CI 0.84-0.92), need for suturing perineal trauma (RR 0.71, 95% CI 0.61-0.81), and healing complications at seven days (RR 0.69, 95% CI 0.56-0.85).13 No difference is shown in the incidence of major outcomes such as severe vaginal and perineal trauma (when both vaginal and perineal trauma are counted) nor in pain, dyspareunia or urinary incontinence. However, the restrictive use of episiotomy has an increased risk of anterior perineal trauma (RR 1.84, 95% CI 1.61-2.10).13 Therefore, it is not advised to practice routine episiotomy.
From a large retrospective studies conducted in Caucasian countries, mediolateral episiotomy has been shown to protect women from OASIS (OR 0.21-0.54). 6,7,18 Besides, there was also evidence showing that Asian women delivered in Caucasian countries with a low episiotomy rate had a high risk of OASIS.19,20 Furthermore, ethnical difference in pelvic connective tissues have been reported.21 And pregnant Chinese women has been shown to smaller genital hiatus and less mobility of pelvic organs than pregnant Caucasian women.22 This may lead to a different outcome in perineal trauma in Asian women with or without episiotomy during vaginal delivery.
There were around 500-7000 deliveries at Prince of Wales Hospital annually. Among them, 50-55% was nulliparous women. About 65-70% of women had normal vaginal delivery and another 5-10% had instrumental delivery. There was a change from 'routine episiotomy' to a more restrictive use of episiotomy in normal vaginal delivery during the last 10 years, with a reduction of rate of episiotomy from 90% to about 50% (from Dept.'s internal audit). The objective of this study is to evaluate the prevalence of OASIS in the era of a reduction of episiotomy. This would help inform obstetricians and midwives if there is any change in rate of OASIS and the relationship with episiotomy. The information would be useful to counsel our patients.
The protocol of current study complies with Declaration of Helsinki.
The HA CMS OBSCIS is the electronic system that have collected the demographic, pregnancy, delivery and postnatal data of pregnant women. The data was entered by midwives and obstetricians during all consultations and admission of delivery of all pregnant women.
In this study, the following information will be retrieved from the CMS OBSCIS database for all delivery conducted from 2011 to 2021.
- Demographic data: age, parity, body weight and height
- Past obstetric history (if any): mode of delivery, birthweight and sex of infant, use of episiotomy
- Delivery data: gestation at delivery, need of induction of labour, analgesics during labour, duration of labour, mode of delivery, use of episiotomy, any perineal tear, blood loss during delivery, need of transfusion, wound complication, duration of hospital stay; and infant's birthweight, sex and apgar score
- For women with OASIS: the method of repair, the symptom of pelvic floor disorders, such as faecal or flatal incontinence, urinary incontinence, symptoms of prolapse after the delivery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All deliveries conducted from 2011 to 2021 in Prince of Wales Hospital | – | Other: No interventionAll deliveries conducted from 2011 to 2021 in Prince of Wales Hospital The target sample size will be about 67,000 women who had delivered in our unit from 2011 to 2021. Among them, it is expected that 75-80% had vaginal deliveries, either normal vaginal delivery or instrumental delivery. 53,600 will be recruited in study site. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- The target sample size will be about 67,000 women who had delivered in our unit from 2011 to 2021. Among them, it is expected that 75-80% had vaginal deliveries, either normal vaginal delivery or instrumental delivery. 53,600 will be recruited in study site.
Key inclusion criteria (1 listed)
- All deliveries conducted from 2011 to 2021 in Prince of Wales Hospital
Key exclusion criteria (1 listed)
- Deliveries with Caesarean Section
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 |
|---|---|---|
| No interventionNo intervention | Other | All deliveries conducted from 2011 to 2021 in Prince of Wales Hospital |
Primary outcome
Prevalence of obstetric anal sphincter injury (third or fourth degree tear) detected clinically immediately after delivery
Time frame: Immediately after delivery
Prevalence of obstetric anal sphincter injury (third or fourth degree tear) detected clinically immediately after delivery
1 secondary outcome
The factors associated with OASIS
Time frame: Immediately after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
- Background: PubMed 15453900Norderval S, Nsubuga D, Bjelke C, Frasunek J, Myklebust I, Vonen B. Anal incontinence after obstetric sphincter tears: incidence in a Norwegian county. Acta Obstet Gynecol Scand. 2004 Oct;83(10):989-94. doi: 10.1111/j.0001-6349.2004.00647.x.
- Background: PubMed 8173367Sultan AH, Kamm MA, Hudson CN, Bartram CI. Third degree obstetric anal sphincter tears: risk factors and outcome of primary repair. BMJ. 1994 Apr 2;308(6933):887-91. doi: 10.1136/bmj.308.6933.887.
- Background: PubMed 11065029Sangalli MR, Floris L, Faltin D, Weil A. Anal incontinence in women with third or fourth degree perineal tears and subsequent vaginal deliveries. Aust N Z J Obstet Gynaecol. 2000 Aug;40(3):244-8. doi: 10.1111/j.1479-828x.2000.tb03330.x.
- Background: PubMed 25117190Tucker J, Clifton V, Wilson A. Teetering near the edge; women's experiences of anal incontinence following obstetric anal sphincter injury: an interpretive phenomenological research study. Aust N Z J Obstet Gynaecol. 2014 Aug;54(4):377-81. doi: 10.1111/ajo.12230.
- Background: PubMed 25040835Edozien LC, Gurol-Urganci I, Cromwell DA, Adams EJ, Richmond DH, Mahmood TA, van der Meulen JH. Impact of third- and fourth-degree perineal tears at first birth on subsequent pregnancy outcomes: a cohort study. BJOG. 2014 Dec;121(13):1695-703. doi: 10.1111/1471-0528.12886. Epub 2014 Jul 9.
- Background: PubMed 11305545de Leeuw JW, Struijk PC, Vierhout ME, Wallenburg HC. Risk factors for third degree perineal ruptures during delivery. BJOG. 2001 Apr;108(4):383-7. doi: 10.1111/j.1471-0528.2001.00090.x.
- Background: PubMed 16817086Aukee P, Sundstrom H, Kairaluoma MV. The role of mediolateral episiotomy during labour: analysis of risk factors for obstetric anal sphincter tears. Acta Obstet Gynecol Scand. 2006;85(7):856-60. doi: 10.1080/00016340500408283.
- Background: PubMed 6346168Thacker SB, Banta HD. Benefits and risks of episiotomy: an interpretative review of the English language literature, 1860-1980. Obstet Gynecol Surv. 1983 Jun;38(6):322-38.
- Background: PubMed 6428627Harrison RF, Brennan M, North PM, Reed JV, Wickham EA. Is routine episiotomy necessary? Br Med J (Clin Res Ed). 1984 Jun 30;288(6435):1971-5. doi: 10.1136/bmj.288.6435.1971.
- BackgroundHouse MJ, Cario G, Jones MH. Episiotomy and the perineum: a random controlled trial. J Obstet Gynaecol 1986;7:107-110
- Background: PubMed 1343606Klein MC, Gauthier RJ, Jorgensen SH, Robbins JM, Kaczorowski J, Johnson B, Corriveau M, Westreich R, Waghorn K, Gelfand MM, et al. Does episiotomy prevent perineal trauma and pelvic floor relaxation? Online J Curr Clin Trials. 1992 Jul 1;Doc No 10:[6019 words; 65 paragraphs]. doi: 10.1097/00006254-199404000-00008.
- Background: PubMed 18221925Rodriguez A, Arenas EA, Osorio AL, Mendez O, Zuleta JJ. Selective vs routine midline episiotomy for the prevention of third- or fourth-degree lacerations in nulliparous women. Am J Obstet Gynecol. 2008 Mar;198(3):285.e1-4. doi: 10.1016/j.ajog.2007.11.007. Epub 2008 Jan 25.
- Individual participant dataSharing planned: No. Undecided
Related trials for Anal Sphincter Injury
Recruiting
Postpartum Health Trajectories the First Year After Obstetric Anal Sphincter Injury and the Impact of a Group-Based Intervention
Obstetric Anal Sphincter Injury
Active, not recruitingPhase 3
Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury
Fecal Incontinence
Enrolling by invitationObservational study
Long-term Pelvic Floor and Sexual Health After Obstetric Anal Sphincter Injury in Finland
Obstetric Anal Sphincter Injury, Sexual Dysfunction and the Mode of Deliveries
Recruiting
Improving Postpartum Quality of Life Through Enhanced Perineal Care Training
Postpartum Quality of Life, Peripartal Maternal Trauma
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
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.
Yan Yan Lau principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anal Sphincter Injury, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 1 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: status not confirmed, as of the sponsor's last update on 15 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Yan Lau (8525569 9272, yanyanlau@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of obstetric anal sphincter injury (third or fourth degree tear) detected clinically immediately after delivery (time frame: Immediately after delivery). 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 NCT05436171, which also lists 22 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 15 Aug 2022.