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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02910310
Other study ID # 3005
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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