ClinicalTrials.gg
Not yet recruitingNCT07609589Updated May 27, 2026

Balloon Tamponade Versus Gauze Packing for Postpartum Hemorrhage

An interventional study of Uterine Balloon Tamponade and Uterine gauze packing in Postpartum Hemorrhage and Uterine Atony, sponsored by Khyber Teaching Hospital. Not yet recruiting. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-05-27.

Sponsored by Khyber Teaching Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
216
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

Postpartum hemorrhage due to uterine atony is a major cause of maternal morbidity and mortality. This randomized controlled trial aims to compare the efficacy of uterine balloon tamponade and uterine gauze packing in controlling bleeding in women with postpartum hemorrhage. A total of 216 participants will be randomly assigned to one of the two treatment groups. All patients will receive standard medical management including uterotonic agents prior to intervention. The primary outcome is cessation of uterine bleeding within 24 hours after the procedure. This study aims to identify a safe and effective method for managing postpartum hemorrhage in a resource-limited setting.

02

Conditions studied

  • Postpartum Hemorrhage
  • Uterine Atony

Keywords

  • postpartum hemorrhage
  • uterine atony
  • balloon tamponade
  • uterine packing
03

In context

Postpartum Hemorrhage

469 studies on the registry are indexed under Postpartum Hemorrhage; 76 are open to participants now.

This study's planned enrollment of 216 is above the median of 148 across 360 interventional studies indexed under Postpartum Hemorrhage.

Browse Postpartum Hemorrhage studies →

Lead sponsor

Khyber Teaching Hospital is the lead sponsor of 29 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Women aged 18 to 40 years
  • Gestational age between 37 and 42 weeks
  • Parity up to 4
  • Diagnosed with postpartum hemorrhage due to uterine atony

Exclusion criteria

Exclusion Criteria:

  • Postpartum hemorrhage due to perineal, cervical, or vaginal trauma
  • Retained products of conception
  • Vaginal delivery after previous cesarean section
  • Known coagulation disorders
  • Sepsis
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
216 participants (estimated)

Study arms

  • Experimental
    Uterine Balloon Tamponade

    Procedure: Uterine Balloon Tamponade

  • Active comparator
    Uterine Gauze Packing

    Procedure: Uterine gauze packing

Interventions

  • ProcedureUterine Balloon Tamponade

    Uterine balloon tamponade will be performed using sterile Foley catheters inserted into the uterine cavity and inflated with normal saline to achieve hemostasis in patients with postpartum hemorrhage due to uterine atony, following standard aseptic techniques.

  • ProcedureUterine gauze packing

    Uterine gauze packing will be performed using sterile gauze placed within the uterine cavity and vagina to apply pressure and control bleeding in patients with postpartum hemorrhage due to uterine atony, following standard aseptic techniques.

06

What researchers measure

Primary outcomes

  1. Successful Control of Postpartum Hemorrhage Assessed by Cessation of Active Uterine Bleeding Without Need for Additional Surgical Intervention

    Successful control of postpartum hemorrhage will be defined as cessation of active uterine bleeding within 24 hours after uterine balloon tamponade or uterine gauze packing, without the need for additional surgical procedures (e.g., hysterectomy, arterial ligation, or repeat tamponade/packing), as assessed clinically by the treating obstetric team.

    Time frame: 24 hours after intervention

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2026; primary completion for Dec 2026, 5 months later.

Of 112 non-industry interventional studies with no phase under Postpartum Hemorrhage, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 26. This study's planned 5 months is below that.

Counting every sponsor, half of 119 studies reached it within 16 months; a quarter within 7 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
May 15, 2026
First posted
May 27, 2026
StartEst.
Jul 1, 2026
Primary completionEst.
Dec 30, 2026
CompletionEst.
Jan 10, 2027
Last update
May 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07609589
Lead sponsor
Khyber Teaching Hospital
Responsible party
Madiha Yar Khan (Principal Investigator, Khyber Teaching Hospital) — Principal investigator
First posted
May 27, 2026
Start date
Jul 1, 2026 (estimated)
Primary completion
Dec 30, 2026 (estimated)
Completion
Jan 10, 2027 (estimated)
Last update
May 27, 2026

Study contacts

Madiha Yar Khan
Contact
madihak067@gmail.com
+923486106764

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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