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

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ClinicalTrials.gov Identifier: NCT03707132
Recruitment Status : Completed
First Posted : October 16, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Ben marzouk Sofiene, University Tunis El Manar

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

Condition or disease Intervention/treatment
Placenta Accreta Post Partum Hemorrhage Blood Loss Massive Procedure: Tourniquet: Folley catheter in the low segment of the uterus

Detailed Description:

It is a monocentric prospective observational case-control study in the Department "C" of Gynecology and Obstetrics in the Maternity and Neonatology Center of Tunis during three years from October 2014 to September 2017.

All parturient were informed about the possibility of performing a hysterectomy if accretization was clinically confirmed preoperatively. After obtaining written formal consent. all patients who underwent scheduled or emergency cesarean section for placenta accreta were included. Either it was highly suspected or confirmed by obstetrical imaging. MRI was always performed in cases of scheduled cesarean delivery. However, in cases of delayed transfer or if parturient was already in labor, only ultrasonography was done and considered as sufficient. Delivery was usually scheduled at 36 weeks of gestation.

Patients were allocated into two group: Group TG in which a tourniquet was systematically applied on the lower segment of the uterus during emergent hysterectomy, control group CG when the emergent caesarian hysterectomy was performed without a tourniquet. Allocation depended on the technique and the decision of the surgeon in charge.

After appropriate conditioning and monitoring, the cesarean section was performed under general anesthesia. The laparotomy was performed through a mid-line incision from the umbilicus to the pubic symphysis. Hysterotomy was made far from the placental insertion which was previously located by ultrasonography. The accretization was clinically checked immediately after delivery but no attempt was made to manually remove the placenta. The umbilical cord was ligated to its insertion and the uterus was quickly sutured with the placenta kept in place. Careful detachment of the bladder-uterus peritoneum was then carried out in order to lower the bladder and reduce the risk of bladder wounds. Tourniquet application procedure is described as following

  1. Suturing hysterotomy with placenta kept in place.
  2. After a cautious dissection a Folley catheter is placed in the lower segment of the uterus as tourniquet.
  3. complete hysterectomy

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Study Type : Observational
Actual Enrollment : 43 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Tourniquet on the Low Segment of the Uterus Reduces Blood Loss in Postpartum Hemorrhage During Hysterectomy for Placenta Accreta: Old But Gold
Actual Study Start Date : October 1, 2014
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : September 30, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Estimated blood loss [ Time Frame: peroperatively ]
    Blood spoliation during procedure

  2. Hemoglobin variation [ Time Frame: First 24 hours ]
    the differnece between the Baseline concentration of Hemoglobin and the lowest hemoglobin concentration noted during the procedure

  3. Transfusion requirements [ Time Frame: First 24 hours ]
    Number of red blood cells units transfused

  4. procedure duration [ Time Frame: peroperatively ]
    Time needed to perform hysterectomy from incision to skin closure

  5. Intensive care transfer rate [ Time Frame: first 24 hours ]
    Intensive care transfer following hysterectomy for placenta accreta


Secondary Outcome Measures :
  1. length of stay in ICU [ Time Frame: time from surgery up to 30 days postoperative ]
    duration of the stay in the ICU following hysterectomy for placenta accreta

  2. clotting disorders [ Time Frame: time from surgery up to 30 days postoperative ]
    Assessed by the incidence of Intravascular disseminated coagulopathy

  3. Bladder wound [ Time Frame: time from surgery up to 30 days postoperative ]
    Incidence of accidental bladder damage

  4. Digestive wound [ Time Frame: time from surgery up to 30 days postoperative ]
    Incidence of accidental digestive lesion



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female pregnant subject
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • No signs of accretetization upon artificial delivery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03707132


Sponsors and Collaborators
University Tunis El Manar
Investigators
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Study Chair: Hayen Maghrebi, Professor Tunis Maternity Center
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Responsible Party: Ben marzouk Sofiene, clinical associate professor, University Tunis El Manar
ClinicalTrials.gov Identifier: NCT03707132    
Other Study ID Numbers: Garrot-Accreta
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ben marzouk Sofiene, University Tunis El Manar:
Tourniquet
low uterus segment
placenta accreta
hysterectomy
massive blood loss management
Additional relevant MeSH terms:
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Postpartum Hemorrhage
Placenta Accreta
Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Placenta Diseases