Tourniquet Reduces Blood Loss in Postpartum Hemorrhage During Hysterectomy for Placenta Accreta

NCT03707132 | Completed

• 1 other identifier: Garrot-Accreta
• Study Type: observational
• Target: 43
• Locations: 0 countries
• Sites: N/A

Brief Summary

Monocentric prospective observational study comparing the use of tourniquet in low uterus segement versus standard procedure in hysterectomy owing to placenta accreta

Conditions

Placenta Accreta; Post Partum Hemorrhage; Blood Loss Massive

Keywords

Tourniquet; low uterus segment; placenta accreta; hysterectomy; massive blood loss management

Outcome Measures

Primary Outcomes (5)

• Estimated blood loss

  Blood spoliation during procedure

  peroperatively

• Hemoglobin variation

  the differnece between the Baseline concentration of Hemoglobin and the lowest hemoglobin concentration noted during the procedure

  First 24 hours

• Transfusion requirements

  Number of red blood cells units transfused

  First 24 hours

• procedure duration

  Time needed to perform hysterectomy from incision to skin closure

  peroperatively

• Intensive care transfer rate

  Intensive care transfer following hysterectomy for placenta accreta

  first 24 hours

Secondary Outcomes (4)

• length of stay in ICU

  time from surgery up to 30 days postoperative

• clotting disorders

  time from surgery up to 30 days postoperative

• Bladder wound

  time from surgery up to 30 days postoperative

• Digestive wound

  time from surgery up to 30 days postoperative

Study Arms (2)

Tourniquet Group

'Tourniquet: Folley catheter in the low segment of the uterus

Procedure: Tourniquet: Folley catheter in the low segment of the uterus

Control Group

Standard hysterectomy is performed

Interventions

Tourniquet: Folley catheter in the low segment of the uterus PROCEDURE

Tourniquet Group

Eligibility Criteria

• Gender Eligibility Details: female pregnant subject
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All parturients with suspected placenta accreta either on MRI if the C section is scheduled or on Ultrasound if an emmergent delivery is set

You may qualify if:

• All patients undergoing scheduled or emergency cesarean section for placenta accreta

You may not qualify if:

• No signs of accretetization upon artificial delivery

Sponsors & Collaborators

• University Tunis El Manar: lead

MeSH Terms

Conditions

Placenta Accreta; Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hayen Maghrebi, Professor

  Tunis Maternity Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical associate professor

Study Record Dates

• First Submitted: October 7, 2018
• First Posted: October 16, 2018
• Study Start: October 1, 2014
• Primary Completion: September 30, 2017
• Study Completion: September 30, 2017
• Last Updated: October 16, 2018

Record last verified: 2018-10