The Postpartum Haemorrhage (PPH) Butterfly Work Package 3

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. .

Study Overview

• Status: Completed
• Conditions: Postpartum Haemorrhage (PPH)
• Intervention / Treatment: Device: The PPH Butterfly

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 Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Merseyside
    • Liverpool, Merseyside, United Kingdom, L8 7SS
      • Liverpool Womens Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 50 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women who have a vaginal delivery following induction of labour and who are within 72 hours of delivery.

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Use of the PPH Butterfly; The PPH Butterfly will be inserted into the vagina of a healthy postnatal woman	Device: The PPH Butterfly; The PPH Butterfly is a simple, low cost device that has been developed to facilitate less invasive compression of the uterus in a PPH

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 8 weeks

Collaborators and Investigators

• Sponsor: Andrew Weeks MD MRCOG
• Collaborators: National Institute for Health Research, United Kingdom; Liverpool Women's NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: February 12, 2016
• First Submitted That Met QC Criteria: February 25, 2016
• First Posted (Estimate): February 26, 2016

Study Record Updates

• Last Update Posted (Actual): March 6, 2018
• Last Update Submitted That Met QC Criteria: March 3, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage
• Other Study ID Numbers: V.2.4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No