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IRCT20221231056999N3 IRCT 2024-05-10 Bahawal Victoria Hospital Effectiveness of Balloon Tamponade with a Condom Catheter versus Using a Sengstaken-Blakemore Tube in Patients with Primary Postpartum Hemorrhage Effectiveness of Balloon Tamponade with a Condom Catheter versus Using a Sengstaken-Blakemore Tube in Patients with Primary Postpartum Hemorrhage 2024-06-01 anticipated 64 Complete https://irct.ir/trial/76626 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Females were divided into two equal groups by a simple lottery method. N/A Primary postpartum hemorrhage. Intervention 1: Intervention group: Balloon tamponade group. Intervention 2: Intervention group: Sengstaken-Blakemore group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is We will decide after the completion of the trial
public Dr. Shamas un Nisa
Circular Road, Bahawalpur
Bahawalpur Pakistan 63100 +92 301 7706383 drshamaamin73@gmail.com Bahawal Victoria Hospital scientific Dr. Shamas un Nisa
Circular Road, Bahawalpur
Bahawalpur Pakistan 63100 +92 301 7706383 drshamaamin73@gmail.com Bahawal Victoria Hospital Pakistan Females aged between 18-40 years Parity 1-6 Gravida 1-6 Gestational age 31 to 41 weeks Primary postpartum hemorrhage (PPH) 18 years 40 years Female Critically ill patients Documented end-organ liver or renal failure (assessed by a medical record) Documented bleeding disorder history, i.e., factor deficiencies (assessed by a medical record). Secondary PPH Retained products of the placenta Chorioamnitis Treatment - Surgery Treatment - Surgery Intervention group: Balloon tamponade group Intervention group: Sengstaken-Blakemore group The effectiveness will be labeled as yes, where there was no blood loss for 24 hours after the removal of the pack or Foleys. Effectiveness will be labeled as failed if there was more than 100 ml of blood loss within 10 minutes after the removal of the balloon tamponade or Sengstaken-Blakemore tube. Timepoint: 24 hours. Method of measurement: Visual evidence of blood loss as per outcome measures. Bahawal Victoria Hospital Approved 2023-03-15 Institutional Ethical Review Board Circular Road, Bahawalpur Bahawalpur Punjab Pakistan