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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Notify MeKey information
Conditions
Sex eligibility
Female
Study type
Observational
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
Primary outcomes
-
Estimated blood loss
Time frame: peroperatively
Blood spoliation during procedure
-
Hemoglobin variation
Time frame: First 24 hours
the differnece between the Baseline concentration of Hemoglobin and the lowest hemoglobin concentration noted during the procedure
-
Transfusion requirements
Time frame: First 24 hours
Number of red blood cells units transfused
-
procedure duration
Time frame: peroperatively
Time needed to perform hysterectomy from incision to skin closure
-
Intensive care transfer rate
Time frame: first 24 hours
Intensive care transfer following hysterectomy for placenta accreta
Secondary outcomes
-
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
-
clotting disorders
Time frame: time from surgery up to 30 days postoperative
Assessed by the incidence of Intravascular disseminated coagulopathy
-
Bladder wound
Time frame: time from surgery up to 30 days postoperative
Incidence of accidental bladder damage
-
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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