Introduction of UBT for PPH Management in Three Countries

Postpartum Hemorrhage Clinical Trial

— UBT  

Official title:

Introduction of a Uterine Balloon Tamponade for Postpartum Hemorrhage in Three Low Income Countries: a Stepped Wedge Cluster Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02910310
• Other study ID #: 3005
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: March 2018

Study information

• Verified date: July 2018
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

To assess the effectiveness of introduction of the UBT, a stepped wedge cluster randomized design will be employed to monitor maternal health outcomes among vaginal deliveries occurring at all participating facilities during the study phases described below:

Baseline phase: A baseline phase will be conducted in all participating sites before training and introduction of the UBT for PPH management. This phase will consist of prospective data collection to establish the baseline rates of key study outcomes.

Step 1 intervention phase: In this phase, participating sites will be randomized such that half will receive training on use of the UBT for PPH management with subsequent introduction into their standard practice and half will continue data collection without UBT introduction.

Step 2 intervention phase: In this phase, the remaining sites will receive training on use of the UBT for PPH management with subsequent introduction into their standard practice. During this phase, all participating sites will continue data collection to document study outcomes and all will be using UBT in their standard practice.

To assess the safety and acceptability of the use of UBT for PPH management, a nested cohort analysis will be done among women diagnosed with PPH during the stepped wedge trial. The investigators will assess the rates of treatment of postpartum infection and examine acceptability of care provided among the following two cohorts of women:

UBT group: All women diagnosed with PPH following a vaginal delivery and who have an attempted UBT placement (including successful or unsuccessful placements).

No-UBT group: All women diagnosed with PPH following a vaginal delivery that do not have an attempted UBT placement.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60105
• Est. completion date: March 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Eligibility for stepped wedge trial:

Inclusion Criteria:

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

Exclusion Criteria:

• 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:

Inclusion criteria

• 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

Exclusion criteria

• Delivery via Cesarean section

• Transferred to another facility before delivery

• Transferred to the participating facility after vaginal delivery elsewhere but died before arrival

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Other:
• Uterine balloon tamponade
An intervention consisting of inserting a condom attached to a urinary catheter into the uterus and inflating it with fluid to stop postpartum bleeding

Locations

Country	Name	City	State
Egypt	Abu Hummus Hospital	Abu Hummus
Egypt	Fayoum General Hospital	Fayoum
Egypt	Ismailia General Hospital	Ismailia
Egypt	Etay el Barood Hospital	Itay al Barud
Egypt	Itsa Hospital	Itsa
Egypt	Kafr el Dawar Hospital	Kafr El Dawar
Senegal	Centre de Santé Gaspard Camara	Dakar
Senegal	Centre de Santé Nabil Choucair	Dakar
Senegal	Centre de Santé Philip Maguilene Senghor	Dakar
Senegal	Hôpital Roi Boudoin	Dakar
Senegal	Centre de Santé Tefess Mbour	Mbour
Senegal	Hôpital Régional de Mbour	Mbour
Uganda	Gombe Hospital	Gombe
Uganda	Itojo Hospital	Itojo
Uganda	Kiryandongo Hospital	Kiryandongo
Uganda	Kitagata Hospital	Kitagata
Uganda	Lyantonde Hospital	Lyantonde
Uganda	Masindi Hospital	Masindi

Sponsors (8)

Lead Sponsor	Collaborator
Gynuity Health Projects	Alexandria University, El Galaa Teaching Hospital, Global Health Uganda, Makerere University, Ministere de la Sante et des Services Sociaux, Ministry of Health and Population, Egypt, Ministry of Health, Uganda

Countries where clinical trial is conducted

Egypt,  Senegal,  Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Proportion of women who receive blood transfusion for PPH management	Proportion of women who receive blood transfusion for PPH management. This outcome will be assessed for the stepped wedge trial.	After delivery and before discharge from facility (usually within 48 hours after delivery)
Secondary	Transfer to next level care	Proportion of women transferred to the next level referral facility due to PPH. This outcome will be assessed for the stepped wedge trial.	After delivery and before discharge from facility (usually within 48 hours after delivery)
Secondary	Treatment for severe postpartum infection	Proportion of women diagnosed with PPH who are hospitalized due to postpartum infection and/or receive intravenous antibiotics to treat postpartum infection after hospital discharge and within 4 weeks postpartum. This outcome will be assessed in the nested cohort analysis.	Within 4 weeks after delivery
Secondary	Level of pain experienced by women postpartum	Level of pain experienced after delivery as reported by women diagnosed with PPH. Pain will be assessed using a 10-point scale. This outcome will be assessed in the nested cohort analysis.	After delivery and before discharge from facility (usually within 48 hours after delivery)