Efficacy of Balloon Tamponade in Post-partum Hemorrhage Within 24 Hours After Delivery

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-35
SponsorAziz Fatimah Medical & Dental College, Faisalabad

About this trial

Postpartum hemorrhage (PPH) is a major cause of maternal death, especially in developing countries like Pakistan where it accounts for up to 34% of maternal deaths. When bleeding after delivery does not stop with medicines like oxytocin and uterine massage, a low-cost method called balloon tamponade can be life-saving.

This study titled "Efficacy of Balloon Tamponade in Post-partum Hemorrhage within 24 Hours After Delivery" will be conducted by Dr. Maryam Aslam (PGR Gynecology and Obstetrics) under supervision of Prof. Dr. Raheela Farhat at Aziz Fatima Hospital, Faisalabad.

The objective is to determine the efficacy of intrauterine balloon tamponade (condom catheter balloon) in controlling primary PPH. Efficacy is defined as successful control of bleeding within six hours of balloon insertion without need for additional surgery, confirmed by absence of active vaginal bleeding, a contracted uterine fundus, and stable maternal condition after removal of the balloon. The results will help promote a simple, effective procedure that can even be used by primary health care workers to reduce maternal mortality.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-35 years

Having gestational age between 31 to 41 weeks

Having PPH (Primary postpartum hemorrhage unresponsive to uterotonics)

Disqualifiers

Patient who has Obstetric hemorrhage (Antepartum Hemorrhage) <31 weeks of gestation

Multiparity (Children more than 5)

Traumatic PPH (cervical and vaginal tears)

Allergy to latex

Trial population

Women aged 18-35 years with gestational age 31-41 weeks presenting with primary postpartum hemorrhage unresponsive to medical management at Department of Obstetrics and Gynaecology, Allied Hospital Faisalabad. Total 121 participants selected via consecutive non-probability sampling as per WHO sample size calculator with 7% margin of error.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • Intrauterine Balloon Tamponade - Condom Catheter

    Device

    Condom-lined sterile rubber catheter inserted into uterus under aseptic technique, held with roller gauze and sponge-holding forceps. Balloon inflated with 300-400 ml normal saline and kept up to 6 hours. If no active bleeding and uterine fundus contracted after 6 hours, balloon deflated at 50 ml/hour to half volume in 2 hours then removed if no bleeding in next 30 min in presence of senior staff. If bleeding persists, tamponade abandoned and surgical intervention pursued. Efficacy is successful control of PPH within 6 hours without additional surgery, confirmed by absence of active vaginal bleeding, contracted fundus and stable maternal condition.

Treatment groups

121 Participants
are divided into 1 treatment group
Group A: This cohort includes 121 women aged 18-35 years with gestational age 31-41 weeks who developed prima1 intervention

Trial outcomes

Primary outcomes

1

Efficacy of intrauterine condom catheter balloon tamponade in control of primary postpartum hemorrhage

Efficacy is defined as successful control of primary PPH within 6 hours of balloon insertion without need for additional surgical intervention. Success confirmed by absence of active vaginal bleeding, contracted uterine fundus on abdominal palpation and stable maternal vital signs and general condition. Failure defined as persistent bleeding or rising fundus requiring surgical intervention.

Time frame
Within 6 hours of intervention and assessed for 30 minutes after deflation

Secondary outcomes

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Aziz Fatima hospital Status unavailable 38000, Faisalābad, Punjab ProvincePakistanPakistan

Sponsors and contacts

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