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Postpartum HemorrhageBakriNCT01980173

Medico-economic Comparison of Postpartum Hemorrhage Management Using the Bakri Balloon and Standard Care

A study testing Routine care and Bakri balloon in people with Postpartum Hemorrhage, run by Centre Hospitalier Universitaire de Nīmes at 7 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study concerns women diagnosed with postpartum hemorrhage and requiring sulprostone therapy. Included patients are randomized to two arms: the "Sulprostone + Bakri balloon" arm versus the "Sulprostone alone" arm. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Postpartum Hemorrhage
What is being tested?
Routine care and Bakri balloon
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
7 sitesFrance
Study dates
5 Sep 2014to 30 Mar 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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient, her person-of-trust, must have given his/her consent and signed the consent form / inclusion decision made by the investigator when a person-of-trust is absent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient is able to fluently read and speak French
  • Blood loss > 500ml and sulprostone treatment is insufficient at 20 minutes
  • Duration of pregnancy > 32 weeks of amenorrhea
  • Uterine atony

Who cannot join

  • The patient is participating in another study except for the followin studies: ElastoMAP, ElastoDéclench, Papillo PMA, GrossPath, LXRs, DGPostPartum
  • The patient is in an exclusion period determined by a previous study
  • The patient is under judicial protection, under tutorship or curatorship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • The patient cannot read French
Show all 10Show fewer
  • The patient was transferred to another center not among the centers participating in this study
  • The patient has a contraindication for a treatment used in this study (Sulprostone), or an incompatible treatment combination
  • The patient has a contraindication for third level techniques
  • The patient has at least one of the following conditions: chorioamnionitis, cervical cancer, uterine rupture, anatomical abnormality preventing the introduction of the device, purulent infection of the vagina, cervix or uterus.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

France7 sites

  • CHU d'Angers - Hôtel-Dieu

    Angers, 49933

  • APHP - Hôpital Antoine Beclere

    Clamart, 92141

  • APHP - Centre Hospitalier Universitaire de Bicêtre

    Le Kremlin-Bicêtre, 94275

  • APHM - Hôpital Nord

    Marseille, 13915

  • CHRU de Montpellier - Hôpital Arnaud de Villeneuve

    Montpellier, 34295

  • CHRU de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, 30029

  • CHU de Saint Etienne - Hôpital Nord

    Saint-Priest-en-Jarez, 42270

Other trials in France

About this study

This study concerns women diagnosed with postpartum hemorrhage and requiring sulprostone therapy. Included patients are randomized to two arms: the "Sulprostone + Bakri balloon" arm versus the "Sulprostone alone" arm.

The main objective of this study is to compare the efficiency of a care strategy including the Bakri balloon to that of routine care without the Bakri balloon via a cost-consequence study juxtaposing costs and the necessity of invasive procedures (arterial embolization, ligation of arteries, hysterectomy, intrauterine sutures) for controlling postpartum hemorrhage.

Being tested
Routine care, Bakri balloon
Keywords
Bakri balloon
Medical subject headings
Postpartum Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Routine careProcedure or surgery

    Following diagnosis with post-partum hemorrhage, an initial 30 minute phase corresponding to current recommendations, an injection of sulprostone, a demonstrated inefficacy of sulprostone 20 minutes after the injection and finally randomization, patients in this arm of the study will continue to have routine care.

  • Bakri balloonDevice

    Following diagnosis with post-partum hemorrhage, an initial 30 minute phase corresponding to current recommendations, an injection of sulprostone, a demonstrated inefficacy of sulprostone 20 minutes after the injection and finally randomization, patients in this arm will be treated with the immediate placement of a Bakri balloon, followed by routine care if necessary.

Study groups in NCT01980173
Study groupRoleWhat they receive
With Bakri balloonExperimentalPatients randomized to this arm will be treated using the Bakri balloon. Intervention: Bakri balloon
Receives: Device: Bakri balloon
Without Bakri balloonActive comparatorPatients randomized to this arm will receive routine care not including the Bakri Balloon. Intervention: Routine Care
Receives: Procedure: Routine care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The % of patients requiring invasive measures for postpartum hemorrhage control.

    Measured: Hospital stay (expected max of 15 days).

  2. The total cost (€) associated with the postpartum hemorrhage management strategy.

    Measured: Hospital stay (expected max of 15 days).

Secondary outcomes (63)

  1. The delay required to stop bleeding post-delivery (min)

    Measured: post-partum (expected maximum of a few hours)

  2. The delay required to stop bleeding post-diagnosis (min)

    Measured: post-partum (expected maximum of a few hours)

  3. The percentage of patients still bleeding 30 minutes after sulprostone injection

    Measured: 30 minutes after sulprostone injection (day 0)

  4. Blood loss (ml) 30 minutes after diagnosis

    Measured: 30 minutes after diagnosis (day 0)

  5. Blood loss (ml) 1 hour after diagnosis

    Measured: 1 hour after diagnosis (day 0)

  6. Blood loss (ml) 2 hours after diagnosis

    Measured: 2 hours after diagnosis (day 0)

  7. Blood loss (ml) 24 hours after diagnosis

    Measured: 24 hours after diagnosis (day 1)

  8. Blood pressure

    Measured: Upon diagnosis (day 0)

  9. Blood pressure

    Measured: 30 minutes after diagnosis (day 0)

  10. Blood pressure

    Measured: 120 minutes after diagnosis (day 0)

  11. Blood pressure

    Measured: 24 hours after diagnosis (day 1)

  12. Blood pressure

    Measured: upon sulprostone injection (day 0)

  13. Blood pressure

    Measured: when placing the Bakri balloon (day 0)

  14. Blood pressure

    Measured: when performing invasive techniques (expected day 0 or 1)

  15. Heart rate

    Measured: Upon diagnosis (day 0)

  16. Heart rate

    Measured: 30 minutes after diagnosis (day 0)

  17. Heart rate

    Measured: 120 minutes after diagnosis (day 0)

  18. Heart rate

    Measured: 24 hours after diagnosis (day 1)

  19. Heart rate

    Measured: upon sulprostone injection (day 0)

  20. Heart rate

    Measured: when placing the Bakri balloon (day 0)

  21. Heart rate

    Measured: when performing invasive techniques (expected day 0 or 1)

  22. The % of patients requiring blood transfusion.

    Measured: Hospital stay (expected max of 15 days).

  23. The % of patients requiring intravenous iron.

    Measured: Hospital stay (expected max of 15 days).

  24. The quantity of packed red cells, platelet concentrate and fresh frozen plasma consumed

    Measured: Hospital stay (expected max of 15 days).

  25. Fibrinogen (g / l)

    Measured: Upon diagnosis (day 0)

  26. Fibrinogen (g / l)

    Measured: Day 1

  27. Fibrinogen (g / l)

    Measured: Day 3

  28. Hematocrit (%)

    Measured: Upon diagnosis (day 0)

  29. Hematocrit (%)

    Measured: Day 1

  30. Hematocrit (%)

    Measured: Day 3

  31. Hematocrit (%)

    Measured: the month preceding delivery

  32. Hemoglobin (g/dl)

    Measured: Upon diagnosis (day 0)

  33. Hemoglobin (g/dl)

    Measured: Day 1

  34. Hemoglobin (g/dl)

    Measured: Day 3

  35. Hemoglobin (g/dl)

    Measured: the month preceding delivery

  36. Prothrombin (%)

    Measured: the month preceding delivery

  37. Prothrombin (%)

    Measured: Upon diagnosis (day 0)

  38. Prothrombin (%)

    Measured: Day 1

  39. Prothrombin (%)

    Measured: Day 3

  40. Activated partial thromboplastin time (s)

    Measured: the month preceding delivery

  41. Activated partial thromboplastin time (s)

    Measured: Upon diagnosis (day 0)

  42. Activated partial thromboplastin time (s)

    Measured: Day 1

  43. Activated partial thromboplastin time (s)

    Measured: Day 2

  44. Length of hospital stay (days)

    Measured: Expected max of 15 days

  45. Length of ICU stay

    Measured: expected max of 15 days

  46. Antimullerian hormone level

    Measured: Upon diagnosis (Day 0)

  47. Antimullerian hormone level

    Measured: 2 months after restart of menses

  48. Amenorrhea at 3 months? yes/no

    (Excluding breastfeeding women)

    Measured: 3 months

  49. The presence of adhesions detected at hysteroscopy

    Measured: 3 months after delivery if menses have restarted, or 2 months after the restart of menses (maximum of 1 year after inclusion)

  50. pain will be assessed in both arms via a visual analog scale, duration, location, and use of analgesics

    Measured: Day 1

  51. pain will be assessed in both arms via a visual analog scale, duration, location, and use of analgesics

    Measured: Day 3

  52. temperature (°C)

    Measured: Daily while in hospital (expected maximum of 15 days)

  53. FSFI questionnaire (Female Sexual Function Index)

    Measured: 6 months

  54. Doppler ultrasound: intrauterine pressure

    Measured: when placing the Bakri balloon; day 0

  55. Doppler ultrasound: thickness of the uterine wall

    Measured: when placing the Bakri balloon; day 0

  56. Doppler ultrasound: inversed diastolic flow

    Measured: when placing the Bakri balloon; day 0

  57. Doppler ultrasound: intraluminal pressure

    Measured: when placing the Bakri balloon; day 0

  58. Doppler ultrasound: uterine artery perfusion pressure

    Measured: when placing the Bakri balloon; day 0

  59. Doppler ultrasound: uterine artery pulsatility index

    Measured: when placing the Bakri balloon; day 0

  60. IES-R scale (symptoms of post-traumatic stress)

    Measured: 6 months

  61. Vascular filling required? yes/no

    Measured: Day 0

  62. If vascular filling is required, volume and type of solution used.

    Measured: Day 0

  63. Were amines required? yes/no

    Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2013 (estimated)
  2. Study start5 Sep 2014
  3. Primary completion26 Sep 2016
  4. Study completion30 Mar 2017

Why it stopped: recruitment difficulties

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01980173
Sponsor's protocol ID
LOCAL/2012/VL-04
Other IDs
2013-A00914-41
Acronym
Bakri
Status last verified
Sep 2016
First submitted
29 Oct 2013
Last updated
11 May 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Kellie FJ, Wandabwa JN, Mousa HA, Weeks AD. Mechanical and surgical interventions for treating primary postpartum haemorrhage. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013663. doi: 10.1002/14651858.CD013663.

    PubMed 32609374

Questions about this trial

What is this clinical trial studying?

A study testing Routine care and Bakri balloon in people with Postpartum Hemorrhage, run by Centre Hospitalier Universitaire de Nīmes at 7 sites in France.

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 10 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: stopped early, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in France. 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 was stopped early (reason given: recruitment difficulties). Results are not available in the source record.

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?

The % of patients requiring invasive measures for postpartum hemorrhage control. (time frame: Hospital stay (expected max of 15 days).). The study lists 2 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 NCT01980173, which also lists 1 linked publication.

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 11 May 2018.

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