Obstetric ComplicationCOMPaRENCT05935371
Consequences of Obstetric Anal Sphincter Injuries on Maternal Psychology and Relationship Experience
An observational study of Obstetric Complication and Obstetric Trauma, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
The aim is to ascertain whether sustaining an Obstetric Anal Sphincter Injury negatively impacts intra-family relationships and increases the risk of mental health conditions, including a women's perception of herself and her self-esteem. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Obstetric Complication, Obstetric Trauma, Perineal Tear
- How many people
- 87 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Oct 2023to Oct 2025
- 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 60 years
- Women only
- Adult
Study population: English-speaking women, over the age of 18, with capacity to consent (able to comprehend and retain information, weight out the risks and benefits and communicate a decision back to the researcher) and who have had a vaginal delivery are eligible to participate in this study.
Who may be able to join
- as aforementioned previously
- Adult women who have had a vaginal delivery
- ≥ 18 years
- Capacity to consent
- English-speaking
- Primiparous/multi-parous
Who cannot join
- Women who have had a caesarean section
- Women who are unable to consent
- Patient who do not speak English
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
London Northwest Healthcare NHS Trust
London, Brent, NW107NS
Sunder CHITA, 0208 8695829, sunderchita@nhs.net
NADA ELSAID, n.elsaid@nhs.net
About this study
Official title: The Impact of Severe Perineal Trauma on Maternal Mental Health and Intra-family Relationships
The aim is to ascertain whether sustaining an Obstetric Anal Sphincter Injury negatively impacts intra-family relationships and increases the risk of mental health conditions, including a women's perception of herself and her self-esteem. Research in this field will ensure that the correct care and adequate support is provided for these patients in the post-natal period and beyond. Recognition of these conditions and the provision of support for these patients may improve relationships, leading to improved parenting and positive outcomes for the child. It ought to be highlighted that the sequelae of obstetric anal sphincter injuries, including anal incontinence, may manifest later on in the female life course and therefore life-long accessibility to help and therapies is advocated for these women.
Read the detailed description
Obstetric anal sphincter injuries encompass grade 3 and 4 perineal tears and effect the integrity of the anorectal sphincter complex, with or without involvement of the anorectal mucosa. Obstetric anal sphincter injuries occur following a vaginal delivery and are more common in primiparae women, occurring with an incidence in the UK of 6.1% compared to 1.7% in those who are multiparae. Although obstetric anal sphincter injuries is fairly uncommon, the rate of these injuries in singleton, cephalic and first vaginal deliveries, has reportedly tripled from 1.8% to 5.9% from 2000 to 2012. This may, however, be secondary to better detection of these injuries following improvements in education, training and the utilization of a standardized classification system for perineal tears. To address the rising obstetric anal sphincter injury rates, the obstetric anal sphincter injury care bundle was introduced which primarily focused on interventions in the antenatal period to reduce the incidence of these injuries. Prevention of these injuries, however, will not always be possible, even with the best efforts of care. Therefore, focus should also be placed on the optimal management of these patients post-partum. This is especially important as these injuries may be associated with a myriad of devastating and stigmatizing sequelae, including faecal and urinary incontinence, dyspareunia, rectovaginal fistulae, perineal pain and pelvic organ prolapse. It is not surprising, therefore, that sustaining such an injury may impact a woman's decision to have another baby. Severe perineal trauma, with or without complications may, understandably, cause a negative impact on the mental health of afflicted mothers.
Suffering from the complications of these injuries may impact on an individual's quality of life and day-to-day functioning, further augmenting the psychological impact of obstetric anal sphincter injuries. Research has highlighted obstetric anal sphincter injuries to be a risk factor for the development of post traumatic stress disorder symptoms. At present, mothers with these injuries are not routinely screened for these conditions in the post-natal period. Preliminary research has shown that acquiring such an injury negatively affects the relationship between a mother and her child, which invariably has a deleterious effect on a child's development.
This study delivers a questionnaire which incorporates existing, screening tools including the Patient Health Questionnaire-9 (PHQ-9), Generalised Anxiety Disorder-7 (GAD-7), Post-traumatic stress disorder checklist (PCL-5), Rosenberg self-esteem score, Arizona sexual experiences scale, Dyadic Adjustment Scale and the Mother infant bonding scale (MIBS) to assess the impact of these injuries on a women's mental health and intra-family relationships. The PHQ-9 has been shown to be on par with the Edinburgh postnatal depression scale in screening for depression in the perinatal period.
Recognition of mental health dysfunction within this cohort, if present, would facilitate early intervention which may in turn reduce the long-term consequences of a traumatic child birth.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case group - women with obstetric anal sphincter injuries | * Adult women who have had a vaginal delivery * ≥ 18 years * Capacity to consent * English-speaking * Primiparous/multi-parous | |
| Control group - women without perineal tears | * Adult women who have had a vaginal delivery * ≥ 18 years * Capacity to consent * English-speaking * Primiparous/multi-parous |
What is being measured
The primary outcome is the main question the study is designed to answer.
the impact of an obstetric anal sphincter injury on
the incidence of depression using the patient health questionnaire-9 screening tool. The binary outcome cut off is 10 for this questionnaire. The higher the score the worse the outcome. Mininum score 0. Maximum score 27.
Measured: study to be completed within 12 months
the impact of an obstetric anal sphincter injury on
the presence and severity of post-traumatic stress disorder using the post-traumatic stress disorder checklist (PCL-5) screening tool. Outcome is continuous. The higher the score, the worse the outcome. Minimum score 0. Maximum score 80.
Measured: study to be completed within 12 months
the impact of an obstetric anal sphincter injury on
patient self-esteem using the rosenberg self-esteem scale. The binary outcome cut off is 15. Range is 0-30. Scores below 15 suggest low self esteem.
Measured: study to be completed within 12 months
the impact of an obstetric anal sphincter injury on
sexual dysfunction (quantifying sex drive, arousal, vaginal lubrication/penile erection, ability to reach and satisfaction from orgasm) using the arizona sexual experiences scale. Range of score from 5-30. A total score > or equal to 19 or any 1 item with an individual score of more than or equal to 5 or any 3 items with individual scores of more than or equal to 4 are highly correlated with the presence of sexual dysfunction.
Measured: study to be completed within 12 months
the impact of an obstetric anal sphincter injury on
quality of a relationship within an intact couple using the abbreviated dyadic adjustment scale (DAS-4). A score of 14 is the binary outcome cut off.0-21 range. Higher the score the better the relationship.
Measured: study to be completed within 12 months
the impact of an obstetric anal sphincter injury on
anxiety using the generalised anxiety disorder-7 screening tool. The binary outcome cut off is 10. Range is 0-21. The higher the score, the greater the anxiety.
Measured: study to be completed within 12 months
the impact of an obstetric anal sphincter injury on
mother to infant bonding using the mother to infant bonding scale. Range score 0-24. The higher the score, the more likely bonding is disrupted.
Measured: study to be completed within 12 months
Secondary outcomes (6)
The influence of the following factor in predicting severity and risk of mental health disorders and relationship dysfunction (specifically pertaining to relationship with partner and child):
age
Measured: study to be completed over a 12 month period
The influence of the following factor in predicting severity and risk of mental health disorders and relationship dysfunction (specifically pertaining to relationship with partner and child):
type of delivery (e.g. instrumental/assisted or spontaneous vaginal delivery)
Measured: study to be completed over a 12 month period
The influence of the following factor in predicting severity and risk of mental health disorders and relationship dysfunction (specifically pertaining to relationship with partner and child):
number of vaginal births
Measured: study to be completed over a 12 month period
The influence of the following factor in predicting severity and risk of mental health disorders and relationship dysfunction (specifically pertaining to relationship with partner and child):
history of previous obstetric anal sphincter injury. The researchers will attempt to obtain this information by reviewing the patient's medical records and asking the patient if they have been previously diagnosed with an obstetric anal sphincter injury.
Measured: study to be completed over a 12 month period
The influence of the following factor in predicting severity and risk of mental health disorders and relationship dysfunction (specifically pertaining to relationship with partner and child):
grade of tear (assessed clinically or radiologically)
Measured: study to be completed over a 12 month period
The influence of the following factor in predicting severity and risk of mental health disorders and relationship dysfunction (specifically pertaining to relationship with partner and child):
Obstetric Anal sphincter Injury (OASI) induced incontinence and severity (as assessed by St Mark's incontinence scale). St Mark's score ranges from 0-24. Abnormal is scores more than 5. The greater the score, the greater the incontinence score.
Measured: study to be completed over a 12 month period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start26 Oct 2023
- Primary completionOct 2024 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Obstetric ComplicationStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London North West Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935371
- Sponsor's protocol ID
- 327802
- Acronym
- COMPaRE
- Status last verified
- Jun 2023
- First submitted
- 4 Jun 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Skari H, Skreden M, Malt UF, Dalholt M, Ostensen AB, Egeland T, Emblem R. Comparative levels of psychological distress, stress symptoms, depression and anxiety after childbirth--a prospective population-based study of mothers and fathers. BJOG. 2002 Oct;109(10):1154-63. doi: 10.1111/j.1471-0528.2002.00468.x.
PubMed 12387470Ertan D, Hingray C, Burlacu E, Sterle A, El-Hage W. Post-traumatic stress disorder following childbirth. BMC Psychiatry. 2021 Mar 16;21(1):155. doi: 10.1186/s12888-021-03158-6.
PubMed 33726703Thornton C, Schmied V, Dennis CL, Barnett B, Dahlen HG. Maternal deaths in NSW (2000-2006) from nonmedical causes (suicide and trauma) in the first year following birth. Biomed Res Int. 2013;2013:623743. doi: 10.1155/2013/623743. Epub 2013 Aug 19.
PubMed 24024205Garthus-Niegel S, Horsch A, Handtke E, von Soest T, Ayers S, Weidner K, Eberhard-Gran M. The Impact of Postpartum Posttraumatic Stress and Depression Symptoms on Couples' Relationship Satisfaction: A Population-Based Prospective Study. Front Psychol. 2018 Sep 19;9:1728. doi: 10.3389/fpsyg.2018.01728. eCollection 2018.
PubMed 30283380Bick Obe D, Hall J, Keighley MRB. The impact of severe perineal trauma on a woman's relationship with her child: a hidden consequence. Midwifery. 2022 May;108:103323. doi: 10.1016/j.midw.2022.103323. Epub 2022 Mar 22. No abstract available.
PubMed 35366595Shonkoff M, Duncan GJ, Yoshikawa H, et al. Maternal depression can undermine the development of young children. Centre on the developing child, Harvard University; 2009.
Sabourin S, Valois P, Lussier Y. Development and validation of a brief version of the dyadic adjustment scale with a nonparametric item analysis model. Psychol Assess. 2005 Mar;17(1):15-27. doi: 10.1037/1040-3590.17.1.15.
PubMed 15769225
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Severe Perineal Trauma on Maternal Mental Health and Intra-family Relationships
- ClinicalTrials.gov ID
- NCT05935371
- Acronym / sponsor ID
- COMPaRE / 327802
- Conditions
- Obstetric Complication, Obstetric Trauma, Perineal Tear, Incontinence, Mental Health Impairment, Relation, Family
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- London North West Healthcare NHS TrustUniversity, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust
- Study start
- 26 Oct 2023 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 7 Jul 2023 (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.
The aim is to ascertain whether sustaining an Obstetric Anal Sphincter Injury negatively impacts intra-family relationships and increases the risk of mental health conditions, including a women's perception of herself and her self-esteem. Research in this field will ensure that the correct care and adequate support is provided for these patients in the post-natal period and beyond. Recognition of these conditions and the provision of support for these patients may improve relationships, leading to improved parenting and positive outcomes for the child. It ought to be highlighted that the sequelae of obstetric anal sphincter injuries, including anal incontinence, may manifest later on in the female life course and therefore life-long accessibility to help and therapies is advocated for these women.
Detailed description
Obstetric anal sphincter injuries encompass grade 3 and 4 perineal tears and effect the integrity of the anorectal sphincter complex, with or without involvement of the anorectal mucosa. Obstetric anal sphincter injuries occur following a vaginal delivery and are more common in primiparae women, occurring with an incidence in the UK of 6.1% compared to 1.7% in those who are multiparae. Although obstetric anal sphincter injuries is fairly uncommon, the rate of these injuries in singleton, cephalic and first vaginal deliveries, has reportedly tripled from 1.8% to 5.9% from 2000 to 2012. This may, however, be secondary to better detection of these injuries following improvements in education, training and the utilization of a standardized classification system for perineal tears. To address the rising obstetric anal sphincter injury rates, the obstetric anal sphincter injury care bundle was introduced which primarily focused on interventions in the antenatal period to reduce the incidence of these injuries. Prevention of these injuries, however, will not always be possible, even with the best efforts of care. Therefore, focus should also be placed on the optimal management of these patients post-partum. This is especially important as these injuries may be associated with a myriad of devastating and stigmatizing sequelae, including faecal and urinary incontinence, dyspareunia, rectovaginal fistulae, perineal pain and pelvic organ prolapse. It is not surprising, therefore, that sustaining such an injury may impact a woman's decision to have another baby. Severe perineal trauma, with or without complications may, understandably, cause a negative impact on the mental health of afflicted mothers.
Suffering from the complications of these injuries may impact on an individual's quality of life and day-to-day functioning, further augmenting the psychological impact of obstetric anal sphincter injuries. Research has highlighted obstetric anal sphincter injuries to be a risk factor for the development of post traumatic stress disorder symptoms. At present, mothers with these injuries are not routinely screened for these conditions in the post-natal period. Preliminary research has shown that acquiring such an injury negatively affects the relationship between a mother and her child, which invariably has a deleterious effect on a child's development.
This study delivers a questionnaire which incorporates existing, screening tools including the Patient Health Questionnaire-9 (PHQ-9), Generalised Anxiety Disorder-7 (GAD-7), Post-traumatic stress disorder checklist (PCL-5), Rosenberg self-esteem score, Arizona sexual experiences scale, Dyadic Adjustment Scale and the Mother infant bonding scale (MIBS) to assess the impact of these injuries on a women's mental health and intra-family relationships. The PHQ-9 has been shown to be on par with the Edinburgh postnatal depression scale in screening for depression in the perinatal period.
Recognition of mental health dysfunction within this cohort, if present, would facilitate early intervention which may in turn reduce the long-term consequences of a traumatic child birth.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group - women with obstetric anal sphincter injuries | – | –* Adult women who have had a vaginal delivery * ≥ 18 years * Capacity to consent * English-speaking * Primiparous/multi-parous |
| Control group - women without perineal tears | – | –* Adult women who have had a vaginal delivery * ≥ 18 years * Capacity to consent * English-speaking * Primiparous/multi-parous |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- English-speaking women, over the age of 18, with capacity to consent (able to comprehend and retain information, weight out the risks and benefits and communicate a decision back to the researcher) and who have had a vaginal delivery are eligible to participate in this study.
Key inclusion criteria (6 listed)
- as aforementioned previously
Key exclusion criteria (3 listed)
- Women who have had a caesarean section
- Women who are unable to consent
- Patient who do not speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the impact of an obstetric anal sphincter injury on
Time frame: study to be completed within 12 months
the incidence of depression using the patient health questionnaire-9 screening tool. The binary outcome cut off is 10 for this questionnaire. The higher the score the worse the outcome. Mininum score 0. Maximum score 27.
the impact of an obstetric anal sphincter injury on
Time frame: study to be completed within 12 months
the presence and severity of post-traumatic stress disorder using the post-traumatic stress disorder checklist (PCL-5) screening tool. Outcome is continuous. The higher the score, the worse the outcome. Minimum score 0. Maximum score 80.
the impact of an obstetric anal sphincter injury on
Time frame: study to be completed within 12 months
patient self-esteem using the rosenberg self-esteem scale. The binary outcome cut off is 15. Range is 0-30. Scores below 15 suggest low self esteem.
the impact of an obstetric anal sphincter injury on
Time frame: study to be completed within 12 months
sexual dysfunction (quantifying sex drive, arousal, vaginal lubrication/penile erection, ability to reach and satisfaction from orgasm) using the arizona sexual experiences scale. Range of score from 5-30. A total score > or equal to 19 or any 1 item with an individual score of more than or equal to 5 or any 3 items with individual scores of more than or equal to 4 are highly correlated with the presence of sexual dysfunction.
the impact of an obstetric anal sphincter injury on
Time frame: study to be completed within 12 months
quality of a relationship within an intact couple using the abbreviated dyadic adjustment scale (DAS-4). A score of 14 is the binary outcome cut off.0-21 range. Higher the score the better the relationship.
the impact of an obstetric anal sphincter injury on
Time frame: study to be completed within 12 months
anxiety using the generalised anxiety disorder-7 screening tool. The binary outcome cut off is 10. Range is 0-21. The higher the score, the greater the anxiety.
the impact of an obstetric anal sphincter injury on
Time frame: study to be completed within 12 months
mother to infant bonding using the mother to infant bonding scale. Range score 0-24. The higher the score, the more likely bonding is disrupted.
6 secondary outcomes
The influence of the following factor in predicting severity and risk of mental health disorders and relationship dysfunction (specifically pertaining to relationship with partner and child):
Time frame: study to be completed over a 12 month period
The influence of the following factor in predicting severity and risk of mental health disorders and relationship dysfunction (specifically pertaining to relationship with partner and child):
Time frame: study to be completed over a 12 month period
The influence of the following factor in predicting severity and risk of mental health disorders and relationship dysfunction (specifically pertaining to relationship with partner and child):
Time frame: study to be completed over a 12 month period
The influence of the following factor in predicting severity and risk of mental health disorders and relationship dysfunction (specifically pertaining to relationship with partner and child):
Time frame: study to be completed over a 12 month period
The influence of the following factor in predicting severity and risk of mental health disorders and relationship dysfunction (specifically pertaining to relationship with partner and child):
Time frame: study to be completed over a 12 month period
The influence of the following factor in predicting severity and risk of mental health disorders and relationship dysfunction (specifically pertaining to relationship with partner and child):
Time frame: study to be completed over a 12 month period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Background: PubMed 12387470Skari H, Skreden M, Malt UF, Dalholt M, Ostensen AB, Egeland T, Emblem R. Comparative levels of psychological distress, stress symptoms, depression and anxiety after childbirth--a prospective population-based study of mothers and fathers. BJOG. 2002 Oct;109(10):1154-63. doi: 10.1111/j.1471-0528.2002.00468.x.
- Background: PubMed 33726703Ertan D, Hingray C, Burlacu E, Sterle A, El-Hage W. Post-traumatic stress disorder following childbirth. BMC Psychiatry. 2021 Mar 16;21(1):155. doi: 10.1186/s12888-021-03158-6.
- Background: PubMed 24024205Thornton C, Schmied V, Dennis CL, Barnett B, Dahlen HG. Maternal deaths in NSW (2000-2006) from nonmedical causes (suicide and trauma) in the first year following birth. Biomed Res Int. 2013;2013:623743. doi: 10.1155/2013/623743. Epub 2013 Aug 19.
- Background: PubMed 30283380Garthus-Niegel S, Horsch A, Handtke E, von Soest T, Ayers S, Weidner K, Eberhard-Gran M. The Impact of Postpartum Posttraumatic Stress and Depression Symptoms on Couples' Relationship Satisfaction: A Population-Based Prospective Study. Front Psychol. 2018 Sep 19;9:1728. doi: 10.3389/fpsyg.2018.01728. eCollection 2018.
- Background: PubMed 35366595Bick Obe D, Hall J, Keighley MRB. The impact of severe perineal trauma on a woman's relationship with her child: a hidden consequence. Midwifery. 2022 May;108:103323. doi: 10.1016/j.midw.2022.103323. Epub 2022 Mar 22. No abstract available.
- BackgroundShonkoff M, Duncan GJ, Yoshikawa H, et al. Maternal depression can undermine the development of young children. Centre on the developing child, Harvard University; 2009.
- Background: PubMed 15769225Sabourin S, Valois P, Lussier Y. Development and validation of a brief version of the dyadic adjustment scale with a nonparametric item analysis model. Psychol Assess. 2005 Mar;17(1):15-27. doi: 10.1037/1040-3590.17.1.15.
- 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.
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 Obstetric Complication and Obstetric Trauma, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
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 6 inclusion and 3 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 13 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 1 site in United Kingdom. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the impact of an obstetric anal sphincter injury on (time frame: study to be completed within 12 months). The study lists 7 primary outcomes in all. 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 NCT05935371, which also lists 7 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 13 Nov 2023.