Introduction of UBT for PPH Management in Three Countries

NCT02910310 | Completed DMC

• 1 other identifier: 3005
• Study Type: interventional
• Target: 60,105
• Locations: 3 countries
• Sites: 18

Brief Summary

This study is a prospective, systematic evaluation to assess the effectiveness and safety of introduction of UBT into PPH care at secondary level and district hospitals in 3 low-resource countries. The first component of the evaluation is a prospective stepped wedge cluster randomized design to assess the potential reduction in PPH-related mortality and invasive procedures (blood transfusion, arterial ligation, hysterectomy and uterine arterial embolization) for PPH performed at participating facilities following introduction of UBT. The second component is a nested cohort analysis to assess the safety and acceptability of UBT among women diagnosed with PPH.

Conditions

Postpartum Hemorrhage

Keywords

Uterine Balloon Tamponade

Outcome Measures

Primary Outcomes (2)

• Maternal death due to PPH or invasive procedures due to PPH

  Proportion of women who experience maternal death due to PPH or who receive invasive procedures (including compression/B Lynch sutures, uterine artery ligation, uterine artery embolization, and hysterectomy) for PPH management. This is the primary outcome for the stepped wedge trial.

  After delivery and before discharge from facility (usually within 48 hours after delivery)

• Treatment of postpartum infection among women diagnosed with PPH

  Proportion of women diagnosed with PPH who receive antibiotics for presumptive or confirmed postpartum infection after hospital discharge and within 4 weeks postpartum. This is the primary outcome for the nested cohort analysis.

  Within 4 weeks after delivery

Secondary Outcomes (4)

• Proportion of women who receive blood transfusion for PPH management

  After delivery and before discharge from facility (usually within 48 hours after delivery)

• Transfer to next level care

  After delivery and before discharge from facility (usually within 48 hours after delivery)

• Treatment for severe postpartum infection

  Within 4 weeks after delivery

• Level of pain experienced by women postpartum

  After delivery and before discharge from facility (usually within 48 hours after delivery)

Study Arms (2)

Baseline period

NO INTERVENTION

The baseline period will involve data collection on study outcomes before uterine balloon tamponade (UBT) is introduced at study sites.

Uterine balloon tamponade

EXPERIMENTAL

The UBT period will involve data collection on study outcomes after providers at sites are trained on UBT use and UBT is introduced into PPH management practice at study sites.

Other: Uterine balloon tamponade

Interventions

Uterine balloon tamponade OTHER

An intervention consisting of inserting a condom attached to a urinary catheter into the uterus and inflating it with fluid to stop postpartum bleeding

Uterine balloon tamponade

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Vaginal delivery at participating facility or referred to participating facility for PPH after vaginal delivery elsewhere

You may not qualify if:

• Delivery via Cesarean section
• Transferred to another facility before delivery
• Transferred to the participating facility after vaginal delivery elsewhere but died before arrival
• Eligibility for nested cohort analysis:
• Vaginal delivery at participating facility or referred to participating facility for PPH after vaginal delivery elsewhere
• Diagnosed and treated for PPH during the stepped wedge trial
• Willing and able to give informed consent
• Agree to participate in a postpartum interview before hospital discharge
• Agree to brief follow-up interview 4 weeks after delivery
• Delivery via Cesarean section
• Transferred to another facility before delivery
• Transferred to the participating facility after vaginal delivery elsewhere but died before arrival

Sponsors & Collaborators

• Gynuity Health Projects: lead
• Ministry of Health and Population, Egypt: collaborator
• Alexandria University: collaborator
• El Galaa Teaching Hospital: collaborator
• Global Health Uganda LTD: collaborator
• Makerere University: collaborator
• Ministry of Health, Uganda: collaborator
• Ministere de la Sante et des Services Sociaux: collaborator

Study Sites (18)

Abu Hummus Hospital

Abū Ḩummuş, Egypt

Location

Fayoum General Hospital

Al Fayyum, Egypt

Location

Ismailia General Hospital

Ismailia, Egypt

Location

Itsa Hospital

Iţsā, Egypt

Location

Etay el Barood Hospital

Ītāy al Bārūd, Egypt

Location

Kafr el Dawar Hospital

Kafr El Dawar, Egypt

Location

Centre de Santé Gaspard Camara

Dakar, Senegal

Location

Centre de Santé Nabil Choucair

Dakar, Senegal

Location

Centre de Santé Philip Maguilene Senghor

Dakar, Senegal

Location

Hôpital Roi Boudoin

Dakar, Senegal

Location

Centre de Santé Tefess Mbour

Mbour, Senegal

Location

Hôpital Régional de Mbour

Mbour, Senegal

Location

Gombe Hospital

Gombe, Uganda

Location

Itojo Hospital

Itojo, Uganda

Location

Kiryandongo Hospital

Kiryandongo, Uganda

Location

Kitagata Hospital

Kitagata, Uganda

Location

Lyantonde Hospital

Lyantonde, Uganda

Location

Masindi Hospital

Masindi, Uganda

Location

Related Publications (1)

• 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

Interventions

Uterine Balloon Tamponade

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

Intervention Hierarchy (Ancestors)

Balloon Occlusion; Catheterization; Therapeutics; Endotamponade; Hemostatic Techniques; Embolization, Therapeutic; Therapeutic Occlusion; Investigative Techniques

Study Officials

• Holly Anger, MPH

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

• Rasha Dabash, MPH

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

• Laura Frye, MPH

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

• Ayisha Diop, MPH

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

• Sam Ononge, MD

  Makerere University

  PRINCIPAL INVESTIGATOR

• Nevine Hassanien, MD

  Consultant

  PRINCIPAL INVESTIGATOR

• Mohamed Cherine Ramadan, MD

  El Galaa Teaching Hospital

  PRINCIPAL INVESTIGATOR

• Emad Darwish, MD

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Bocar Daff, MD

  Ministry of Health, Senegal

  PRINCIPAL INVESTIGATOR

• Beverly Winikoff, MD, MPH

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 15, 2016
• First Posted: September 22, 2016
• Study Start: October 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: March 1, 2018
• Last Updated: July 26, 2018

Record last verified: 2018-07

Locations

UG (6); SE (6); EG (6)