Postpartum Haemorrhage (PPH)NCT02692287
The Postpartum Haemorrhage (PPH) Butterfly Work Package 3
A study testing The PPH Butterfly in people with Postpartum Haemorrhage (PPH), run by Andrew Weeks MD MRCOG at 1 site in United Kingdom.
Trial summary
The Postpartum Haemorrhage (PPH) Butterfly is a simple, low-cost device which has been developed as a treatment method for PPH. It will be used to stop the bleeding through compression of the uterus of women having a PPH. Read more about this study
- Who is it for?
- Ages 16 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Haemorrhage (PPH)
- What is being tested?
- The PPH Butterfly
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2016to 1 Apr 2017
- 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 16 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Women who have a vaginal delivery following induction of labour and who are within 72 hours of delivery.
Who cannot join
- Women assessed antenatally to have learning difficulties that may have the potential to impair their decision making
- Women aged < 16 years of age
- Women who cannot read or understand the level of English used in the study documentation
- Women who've had a stillbirth (in this pregnancy)
- Women who have undergone Female Genital Mutilation/vaginal surgery which is unreversed (assessed antenatally)
- Women with clotting disorders; either longstanding or following intrapartum events
Show all 9Show fewer
- Women who have just had, or are having an ongoing PPH
- Women in whom the third stage of labour is not complete (placenta remains in situ).
- Women who have had a caesarean section
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Liverpool Womens Hospital
Liverpool, Merseyside, L8 7SS
About this study
Official title: The Postpartum Haemorrhage (PPH) Butterfly Work Package 3, Phase I in Vivo Testing
The Postpartum Haemorrhage (PPH) Butterfly is a simple, low-cost device which has been developed as a treatment method for PPH. It will be used to stop the bleeding through compression of the uterus of women having a PPH. It will be markedly easier to undertake than traditional bimanual compression, whilst also being significantly more acceptable to women themselves. Use of the PPH Butterfly will provide an alternative management option for PPH and in some cases should avoid the need for women to have to go to theatre for treatment. This research will allow the investigators to determine if they have the optimum size and shape of the device, that it will operate as intended when compressing the uterus, and to gauge its acceptability to participants and users. In phase I the investigators will recruit "healthy volunteers" i.e. women who have delivered their baby vaginally following Induction of labour (IOL) however these women will not be experiencing a PPH. The device is to be assessed purely on size, usability and acceptability not for diagnosis or as a treatment method. Following the delivery participants will be invited to have the PPH Butterfly inserted vaginally for an average of 2 minutes. It is through this that the investigators will assess the suitability of the device in its current design, when it is in practice. The clinician who operates the device will complete a Likert scale questionnaire along with some open questions following each administration. Participants will also answer a short questionnaire. .
Read the detailed description
The study will involve 5-10 healthy women who deliver their baby vaginally following Induction of Labour (IOL). The women will be given a short leaflet regarding the study. During their time on the Induction of Labour (IOL) Suite, women will be seen by a member of the research team, the research will be discussed with them and they will receive a Participant Information Sheet if they desire. The woman will also be shown a short video regarding the Postpartum Haemorrhage (PPH)Butterfly which is specifically for members of the public. After a discussion of the research, women will be asked to indicate in writing whether they may consider participation, whether they do not want to participate, or whether they are undecided but are happy to be asked again. Only those women who are considering participation, or who are happy to be asked again will be approached post-delivery. All of the women can be approached up to 72 hours post-delivery and asked if they wish to participate. If a woman has a vaginal delivery, a member of the research team will then attend the Delivery Suite, maternity theatre (the woman may have had an instrumental delivery in theatre) or the postnatal ward once informed by the midwife caring for her. They will clarify with the woman if she wishes to participate. Assuming the woman wishes to participate, informed, signed consent will be sought at this point and the device will be used, with a speculum examination taking place before and after use of the device.
If the device is of an incorrect size, then the device size will be changed before repeating the process with 5-10 more women. In this way the final recruitment number may be more than 10 in total.
- Conditions
- Postpartum Haemorrhage (PPH)
- Being tested
- The PPH Butterfly
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The PPH ButterflyDevice
The PPH Butterfly is a simple, low cost device that has been developed to facilitate less invasive compression of the uterus in a PPH
| Study group | Role | What they receive |
|---|---|---|
| Use of the PPH Butterfly | Other | The PPH Butterfly will be inserted into the vagina of a healthy postnatal woman Receives: Device: The PPH Butterfly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants for whom the PPH Butterfly is the correct size
This outcome measure will be assessed through the use of a Likert scale questionnaire
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study start1 Mar 2016
- Primary completion1 Mar 2017
- Study completion1 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Haemorrhage (PPH)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- If the device is not of the correct size, then the device is changed and the recruitment process is repeated until the correct size is obtained.
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrew Weeks MD MRCOG
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Liverpool Women's NHS Foundation Trust
- Responsible party
- Sponsor-investigator, Andrew Weeks MD MRCOG, University of Liverpool
- Investigators
- Andrew Weeks, Principal investigator, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692287
- Sponsor's protocol ID
- V.2.4
- Status last verified
- Mar 2018
- First submitted
- 12 Feb 2016
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Postpartum Haemorrhage (PPH) Butterfly Work Package 3, Phase I in Vivo Testing
- ClinicalTrials.gov ID
- NCT02692287
- Acronym / sponsor ID
- V.2.4
- Conditions
- Postpartum Haemorrhage (PPH)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Andrew Weeks MD MRCOGUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Liverpool Women's NHS Foundation Trust
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 26 Feb 2016 (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.
The Postpartum Haemorrhage (PPH) Butterfly is a simple, low-cost device which has been developed as a treatment method for PPH. It will be used to stop the bleeding through compression of the uterus of women having a PPH. It will be markedly easier to undertake than traditional bimanual compression, whilst also being significantly more acceptable to women themselves. Use of the PPH Butterfly will provide an alternative management option for PPH and in some cases should avoid the need for women to have to go to theatre for treatment. This research will allow the investigators to determine if they have the optimum size and shape of the device, that it will operate as intended when compressing the uterus, and to gauge its acceptability to participants and users. In phase I the investigators will recruit "healthy volunteers" i.e. women who have delivered their baby vaginally following Induction of labour (IOL) however these women will not be experiencing a PPH. The device is to be assessed purely on size, usability and acceptability not for diagnosis or as a treatment method. Following the delivery participants will be invited to have the PPH Butterfly inserted vaginally for an average of 2 minutes. It is through this that the investigators will assess the suitability of the device in its current design, when it is in practice. The clinician who operates the device will complete a Likert scale questionnaire along with some open questions following each administration. Participants will also answer a short questionnaire. .
Detailed description
The study will involve 5-10 healthy women who deliver their baby vaginally following Induction of Labour (IOL). The women will be given a short leaflet regarding the study. During their time on the Induction of Labour (IOL) Suite, women will be seen by a member of the research team, the research will be discussed with them and they will receive a Participant Information Sheet if they desire. The woman will also be shown a short video regarding the Postpartum Haemorrhage (PPH)Butterfly which is specifically for members of the public. After a discussion of the research, women will be asked to indicate in writing whether they may consider participation, whether they do not want to participate, or whether they are undecided but are happy to be asked again. Only those women who are considering participation, or who are happy to be asked again will be approached post-delivery. All of the women can be approached up to 72 hours post-delivery and asked if they wish to participate. If a woman has a vaginal delivery, a member of the research team will then attend the Delivery Suite, maternity theatre (the woman may have had an instrumental delivery in theatre) or the postnatal ward once informed by the midwife caring for her. They will clarify with the woman if she wishes to participate. Assuming the woman wishes to participate, informed, signed consent will be sought at this point and the device will be used, with a speculum examination taking place before and after use of the device.
If the device is of an incorrect size, then the device size will be changed before repeating the process with 5-10 more women. In this way the final recruitment number may be more than 10 in total.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- If the device is not of the correct size, then the device is changed and the recruitment process is repeated until the correct size is obtained.
| Arm | Type | Receives |
|---|---|---|
| Use of the PPH Butterfly | Other | Device: The PPH ButterflyThe PPH Butterfly will be inserted into the vagina of a healthy postnatal woman |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Women who have a vaginal delivery following induction of labour and who are within 72 hours of delivery.
Key exclusion criteria (9 listed)
- Women assessed antenatally to have learning difficulties that may have the potential to impair their decision making
- Women aged < 16 years of age
- Women who cannot read or understand the level of English used in the study documentation
- Women who've had a stillbirth (in this pregnancy)
- Women who have undergone Female Genital Mutilation/vaginal surgery which is unreversed (assessed antenatally)
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 |
|---|---|---|
| The PPH ButterflyThe PPH Butterfly is a simple, low cost device that has been developed to facilitate less invasive compression of the uterus in a PPH | Device | Use of the PPH Butterfly |
Primary outcome
Number of participants for whom the PPH Butterfly is the correct size
Time frame: Up to 8 weeks
This outcome measure will be assessed through the use of a Likert scale questionnaire
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 6 Mar 2018.
- Individual participant dataSharing planned: No
Related trials for Postpartum Haemorrhage (PPH)
RecruitingObservational study
Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
Postpartum Hemorrhage, Treatment Outcome
Not yet recruiting
Comparing Simulated Patients and Manikin Based Simulation in Obstetrics
PPH - Postpartum Hemorrhage, Eclampsia
Active, not recruitingObservational study
Intact Cord Placental Delivery vs Delayed Cord Clamping
Intact Cord Placental Delivery, Delayed Cord Clamping
RecruitingEarly Phase 1
Topical Tranexamic Acid to Reduce Blood Loss During Cesarean Delivery
Cesarean Delivery, Postpartum Hemorrhage (PPH)
RecruitingObservational study
Prediction of Platelet Function Using Viscoelastic Test (ROTEM® Sigma) in Obstetric Anesthesia.
Thrombocytopenia, Postpartum Haemorrhage (PPH)
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.
Andrew Weeks principal investigator
University of Liverpool
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The PPH Butterfly in people with Postpartum Haemorrhage (PPH), run by Andrew Weeks MD MRCOG 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 1 inclusion and 9 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 6 Mar 2018. 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?
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?
Number of participants for whom the PPH Butterfly is the correct size (time frame: Up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2018.