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

• Sponsor: University Tunis El Manar (Other)
• Overall Status: Completed
• CT.gov ID: NCT03707132
• Collaborator: (none)
• Enrollment: 43
• Actual Duration (Months): 36

Study Details

Study Description

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	Phase
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

Study Design

• 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: Oct 1, 2014
• Actual Primary Completion Date: Sep 30, 2017
• Actual Study Completion Date: Sep 30, 2017

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Estimated blood loss [peroperatively]

   Blood spoliation during procedure

2. Hemoglobin variation [First 24 hours]

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

3. Transfusion requirements [First 24 hours]

   Number of red blood cells units transfused

4. procedure duration [peroperatively]

   Time needed to perform hysterectomy from incision to skin closure

5. Intensive care transfer rate [first 24 hours]

   Intensive care transfer following hysterectomy for placenta accreta

Secondary Outcome Measures

1. length of stay in ICU [time from surgery up to 30 days postoperative]

   duration of the stay in the ICU following hysterectomy for placenta accreta

2. clotting disorders [time from surgery up to 30 days postoperative]

   Assessed by the incidence of Intravascular disseminated coagulopathy

3. Bladder wound [time from surgery up to 30 days postoperative]

   Incidence of accidental bladder damage

4. Digestive wound [time from surgery up to 30 days postoperative]

   Incidence of accidental digestive lesion

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• No signs of accretetization upon artificial delivery

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University Tunis El Manar

Investigators

• Study Chair: Hayen Maghrebi, Professor, Tunis Maternity Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ben marzouk Sofiene, clinical associate professor, University Tunis El Manar
• ClinicalTrials.gov Identifier: NCT03707132
• Other Study ID Numbers: Garrot-Accreta
• First Posted: Oct 16, 2018
• Last Update Posted: Oct 16, 2018
• Last Verified: Oct 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ben marzouk Sofiene, clinical associate professor, University Tunis El Manar: Tourniquet; low uterus segment; placenta accreta; hysterectomy; massive blood loss management
• Additional relevant MeSH terms: Postpartum Hemorrhage; Placenta Accreta; Hemorrhage

Study Results

No Results Posted as of Oct 16, 2018