A comparative study for efficacy and safety of insertion of ESM UBT(for prevention of PPH) with IM oxytocin 10 IU versuss only IM oxytocin 10 IU

A COMPARATIVE STUDY OF SAFETY AND EFFICACY OF PROPHYLACTIC INSERTION OF DR.BURKES EVERY SECOND MATTERS UTERINE BALLOON TAMPONADE(ESM-UBT) WITH I.M OXYTOCIN VS ONLY I.M OXYTOCIN FOR PREVENTION OF ATONIC PPH IN WOMEN

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/09/057173

Enrollment

226

Registered

2023-09-01

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O72- Postpartum hemorrhage

Interventions

Intervention1: Dr BURKES Every Second Matters - Uterine Balloon Tamponade with Inj Oxytocin 10 IU I M: Group 1 - DR BURKES ESM-UBT Is applied with Inj Oxytocin 10 IU I M given within 5minutes after de

Eligibility

Inclusion criteria

Inclusion criteria: Delivering viable babies with high-risk pregnancies who are prone to atonic PPH Grand multipara Hydramnios Pregnancy-induced hypertension Eclampsia Gestational Diabetes mellitus Prolonged labour Abruption Deranged coagulation profile Fibroids Anemia Twin pregnancy

Exclusion criteria

Exclusion criteria: Patient with traumatic PPH Adherent or retained placenta Uterine rupture Anomalous uterus Suspected chorioamnionitis Purulent infections in cervix, vagina or uterus. Known advanced cervical cancer

Design outcomes

Primary

Measure	Time frame
To compare the blood loss in women in which Dr Burkes UBTwith I.M oxytocin was used to those in whom only I.M oxytocin is used. Timepoint: Measuring Blood loss immediately after inserting UBT post delivery & 48hrs after delivery	—

Secondary

Measure	Time frame
To assess the safety & efficacy of UBT To study the adverse effects of using UBT To assess the need for surgical intervention To assess the need for uterotonic drugs Timepoint: 18months	—

Countries

India

Contacts

Public ContactDR D SANTHOSHI

SHRI B.M.PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER

ryaliwal@gmail.com9845152240

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026