The Postpartum Haemorrhage (PPH) Butterfly Work Package 3

NCT02692287 | Completed DMC

• 1 other identifier: V.2.4
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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. 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. .

Conditions

Postpartum Haemorrhage (PPH)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Use of the PPH Butterfly

OTHER

The PPH Butterfly will be inserted into the vagina of a healthy postnatal woman

Device: The PPH Butterfly

Interventions

The PPH Butterfly DEVICE

The PPH Butterfly is a simple, low cost device that has been developed to facilitate less invasive compression of the uterus in a PPH

Use of the PPH Butterfly

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Liverpool Womens Hospital

Liverpool, Merseyside, L8 7SS, United Kingdom

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew Weeks

  University of Liverpool

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of International Maternal Health

Model Details: 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.

Study Record Dates

• First Submitted: February 12, 2016
• First Posted: February 26, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: April 1, 2017
• Last Updated: March 6, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)