Glove-loaded Foley's Catheter Tamponade for Cesarean Section for Placenta Previa

NCT03570723 | Completed

• 1 other identifier: aswu/201/18
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To investigate the effect of A glove-loaded Foley's catheter tamponade versus stepwise uterine devascularization on blood loss during cesarean section (CS) in patients with complete placenta previa.

Conditions

Placenta Previa; Post Partum Hemorrhage

Outcome Measures

Primary Outcomes (1)

• intraoperative blood loss

  blood loss during operation

  during the operation

Secondary Outcomes (3)

• cesarean hysterectomy

  intraoperative

• need for blood transfusion

  intraoperative and post operative 4 hours blood loss estimation

• postoperative blood loss

  4 hours post operative

Study Arms (2)

stepwise uterine devascularization

ACTIVE COMPARATOR

Uterine hemostatic sutures, through examination of the placental bed, may use some hemostasis at the placental bed,"overswing" was commenced using endo-uterine sutures. If there is still significant bleeding, bilateral uterine artery ligation, and internal iliac artery ligation when needed.BUAL started immediately through blunt dissection downwards and laterally of the peritoneum covering the uterine isthmus and cervix. The peritoneum is mobilized freely at the uterine angles to expose both uterine arteries and avoid inclusion of the ureters in the ligation. The uterine artery pulsations were palpated digitally at the level of the internal os.

Procedure: stepwise uterine devascularization

A glove-loaded Foley's catheter

EXPERIMENTAL

A glove-loaded Foley's catheter tamponade, the internal os of the cervix was identified and a double-way 20 Fr Foley's catheter with a 30-50-ml balloon was inserted through the cervix to be handled by an assistant through the vagina and fixed to the patient's lower limb after inflation of the catheter balloon by 300 ml warm saline and pulling it against the lower uterine segment between the two transverse sutures. Only one glove-loaded Foley's catheter was used for tamponade.

Procedure: A glove-loaded Foley's catheter tamponade

Interventions

A glove-loaded Foley's catheter tamponade PROCEDURE

A glove-loaded Foley's catheter tamponade, the internal os of the cervix was identified and a double-way 20 Fr Foley's catheter with a 30-50-ml balloon was inserted through the cervix to be handled by an assistant through the vagina and fixed to the patient's lower limb after inflation of the catheter balloon by 300 ml warm saline and pulling it against the lower uterine segment between the two transverse sutures. Only one glove-loaded Foley's catheter was used for tamponade.

Also known as: Foley's tamponade

A glove-loaded Foley's catheter

stepwise uterine devascularization PROCEDURE

Uterine hemostatic sutures, through examination of the placental bed, may use some hemostasis at the placental bed,"overswing" was commenced using endo-uterine sutures. If there is still significant bleeding, bilateral uterine artery ligation, and internal iliac artery ligation when needed.BUAL started immediately through blunt dissection downwards and laterally of the peritoneum covering the uterine isthmus and cervix. The peritoneum is mobilized freely at the uterine angles to expose both uterine arteries and avoid inclusion of the ureters in the ligation. The uterine artery pulsations were palpated digitally at the level of the internal os.

stepwise uterine devascularization

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• all pregnant women with a single-term fetus scheduled for elective CD for complete placenta previa

You may not qualify if:

• Patients with the cardiac, hepatic, renal, or thromboembolic disease;
• patients with the high possibility of morbid adherent placenta;
• known coagulopathy, and
• those presented with severe antepartum hemorrhage were excluded.

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

AswanUH

Aswān, 81528, Egypt

Location

Related Publications (1)

• Kellie FJ, Wandabwa JN, Mousa HA, Weeks AD. Mechanical and surgical interventions for treating primary postpartum haemorrhage. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013663. doi: 10.1002/14651858.CD013663.

  PMID: 32609374 DERIVED

MeSH Terms

Conditions

Placenta Previa; 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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants were blinded to the procedure performed.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: The study was single-blind randomized controlled trial carried out in a tertiary University Hospital between June 2018to June 2021. Investigators included patients scheduled for CS due to complete placenta previa. They were randomly allocated to the group (I) managed by stepwise uterine devascularization, group (II) managed by A glove-loaded Foley's catheter tamponade. The primary outcome was the amount of intraoperative estimated blood loss.

Study Record Dates

• First Submitted: May 6, 2018
• First Posted: June 27, 2018
• Study Start: May 1, 2018
• Primary Completion: May 1, 2021
• Study Completion: August 1, 2021
• Last Updated: August 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)