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Completed

NCT Number: NCT03707132

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

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

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Key information

About this study

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

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • No signs of accretetization upon artificial delivery

Treatment and study plan

Tourniquet: Folley catheter in the low segment of the uterus

Procedure

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Tunis El Manar

Other

Registry information

Official study title

Tourniquet on the Low Segment of the Uterus Reduces Blood Loss in Postpartum Hemorrhage During Hysterectomy for Placenta Accreta: Old But Gold

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 16, 2018
Registry last updated
Oct 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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