Intrauterine Tamponade With a Belfort-Dildy Balloon in the Treatment of Immediate Postpartum Hemorrhage

NCT02226731 | Completed DMC

• 1 other identifier: P130914
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the impact of early intrauterine tamponade with a Belfort-Dildy balloon catheter in immediate postpartum hemorrhage(IPPH) after vaginal delivery and refractory to first-line uterotonic treatment, ie performed at the same time as second line uterotonic treatment, as compared tolate intrauterine tamponade performed in case of failure of second line uterotonic treatment, on the final severity of PPH. ).

Conditions

Immediate Postpartum Hemorrhage

Keywords

Immediate postpartum hemorrhage; Intrauterine balloon tamponade

Outcome Measures

Primary Outcomes (1)

• Proportion of women who received at least 3 RBC units for the treatment of PPH and /or who had a calculated peripartum blood loss > 1000 ml.

  With Calculated peripartum blood loss= estimated blood volume × ((prepartum Ht - Day 2postpartum Ht)/prepartum Ht ) and Estimated blood volume (ml) = booking weight (kg) × 85)

  1 day

Secondary Outcomes (17)

• Other markers of severe hemorrhage

  1 day

• Other markers of severe hemorrhage

  24 hours

• Other markers of severe hemorrhage

  8 days

• Other markers of severe hemorrhage

  8 days

• Other markers of severe hemorrhage

  8 days

Study Arms (2)

Early Belfort-Dildy balloon device

EXPERIMENTAL

Device: Early Belfort-Dildy Balloon

Late Belfort-Dildy balloon device

OTHER

Device: Late Belfort-Dildy balloon

Interventions

Early Belfort-Dildy Balloon DEVICE

Intrauterine tamponade with the Belfort-Dildy balloon, performed in the 15 minutes after randomization at the same time as the second line uterotonic treatment.

Early Belfort-Dildy balloon device

Late Belfort-Dildy balloon DEVICE

Intrauterine tamponade with the Belfort-Dildy balloon, performed if failure of second line uterotonic treatment, ie persisting bleeding 30 minutes after the beginning of this infusion.

Late Belfort-Dildy balloon device

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The trial will include women:
• aged 18 years or older,
• who have just had a vaginal delivery
• between 35 and 42 weeks of gestation
• with a PPH persisting 15 minutes after the injection of 5 UI or 10 IU of oxytocin by slow IV and uterine massage,
• Patient beneficiary or affiliated to a health insurance

You may not qualify if:

• The trial will not include women:
• who have just had a cesarean delivery
• with a contraindication to Sulprostone
• with clinical chorioamnionitis or an in utero fetal death
• or a medically-indicated termination of pregnancy
• with PPH secondary to cervicovaginal lacerations without any uterine hemorrhage, uterine rupture, or placenta accreta
• with arterial bleeding requiring embolization
• with a purulent infection of the cervix, vagina or uterus
• with symptoms indicating a hysterectomy
• with cervical cancer
• with a uterine malformation
• or who refuses to sign the informed consent.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

CHI de Poissy Saint Germain en Laye

Poissy, 78303, France

Location

Related Publications (6)

• Rozenberg P, Sentilhes L, Goffinet F, Vayssiere C, Senat MV, Haddad B, Morel O, Garabedian C, Vivanti A, Perrotin F, Kayem G, Azria E, Raynal P, Verspyck E, Sananes N, Gallot D, Bretelle F, Seco A, Winer N, Deneux-Tharaux C; Groupe de Recherche en Obstetrique et Gynecologie. Efficacy of early intrauterine balloon tamponade for immediate postpartum hemorrhage after vaginal delivery: a randomized clinical trial. Am J Obstet Gynecol. 2023 Nov;229(5):542.e1-542.e14. doi: 10.1016/j.ajog.2023.05.014. Epub 2023 May 18.

  PMID: 37209893 BACKGROUND

• Laas E, Bui C, Popowski T, Mbaku OM, Rozenberg P. Trends in the rate of invasive procedures after the addition of the intrauterine tamponade test to a protocol for management of severe postpartum hemorrhage. Am J Obstet Gynecol. 2012 Oct;207(4):281.e1-7. doi: 10.1016/j.ajog.2012.08.028. Epub 2012 Aug 17.

  PMID: 23021688 BACKGROUND

• Georgiou C. Balloon tamponade in the management of postpartum haemorrhage: a review. BJOG. 2009 May;116(6):748-57. doi: 10.1111/j.1471-0528.2009.02113.x.

  PMID: 19432563 BACKGROUND

• Tindell K, Garfinkel R, Abu-Haydar E, Ahn R, Burke TF, Conn K, Eckardt M. Uterine balloon tamponade for the treatment of postpartum haemorrhage in resource-poor settings: a systematic review. BJOG. 2013 Jan;120(1):5-14. doi: 10.1111/j.1471-0528.2012.03454.x. Epub 2012 Aug 13.

  PMID: 22882240 BACKGROUND

• Revert M, Cottenet J, Raynal P, Cibot E, Quantin C, Rozenberg P. Intrauterine balloon tamponade for management of severe postpartum haemorrhage in a perinatal network: a prospective cohort study. BJOG. 2017 Jul;124(8):1255-1262. doi: 10.1111/1471-0528.14382. Epub 2016 Oct 25.

  PMID: 27781401 BACKGROUND

• 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.

  PMID: 32609374 DERIVED

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

• Patrick ROZENBERG, MD

  Department of Obstetrics, Poissy-Saint Germain Hospital Center

  PRINCIPAL INVESTIGATOR

• Catherine DENEUX - THARAUX, MD, PhD

  Institut National de la Santé Et de la Recherche Médicale, France

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2014
• First Posted: August 27, 2014
• Study Start: February 8, 2017
• Primary Completion: June 30, 2020
• Study Completion: August 18, 2020
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)