Clinical trial NCT03570723: Glove-loaded Foley's Catheter Tamponade for Cesarean Section for Placenta Previa
Official title: Glove-loaded Foley's Catheter Tamponade to Reducing Blood Loss During Cesarean Delivery for Complete Placenta Previa: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Placenta Previa
Post Partum Hemorrhage
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2018-06-27
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Detailed description: Postpartum hemorrhage (PPH) due to placenta previa is usually from the placental bed at the lower uterine segment and it occurs after the placenta separation.

Despite placenta previa can be diagnosed by obstetrician before delivery nowadays, still a leading etiology of maternal mortality and morbidity.

Placenta previa is an obstetric condition that is closely linked with massive obstetric hemorrhage. Is not only associated with increased chance of requiring massive transfusion (\> 3 units of packed red blood cells) but also a is now the leading etiology of the cesarean hysterectomies. The incidence has progressively risen worldwide, mainly due to the increasing rates of cesarean section.

Uterine tamponade can be considered as a line of treatment before performing surgical procedures in PPH resulting from the placental site bleeding. It can save the life, avoid laparotomy and preserve fertility.

Nowadays, the use of intrauterine balloons has been developed and become effective for the control of placental site bleeding not responding to medical treatment.

The 2-way Foley's catheter has many advantages over the gauze packing; first, it allows drainage of blood, so no occult bleeding could be accumulated inside the uterus as in uterine gauze, second the removal of the Foley's catheter balloon is easy and not painful, third, the removal of 2-way Foley's catheter could be gradual as a test of its effectiveness before complete removal.

Bakri intrauterine balloon tamponade is used for the treatment of obstetric hemorrhage during cesarean delivery and many recent reports had described the successful use of balloon tamponade to manage hemorrhage due to placenta previa- with an overall success rate of 80%. However; its price is high so in our country, its availability and use are difficult.

So, the aims of this study to assess 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.

The study will be single blinded randomized controlled trial carried out in a tertiary University Hospital between June 2018to June 2021. The included patients will be scheduled for CS due to complete placenta previa. They will be 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 will be the amount of intraoperative estimated blood loss.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* • 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.

Primary outcomes:
measure: intraoperative blood loss
timeFrame: during the operation
Secondary outcomes:
measure: cesarean hysterectomy
timeFrame: intraoperative
measure: need for blood transfusion
timeFrame: intraoperative and post operative 4 hours blood loss estimation
measure: postoperative blood loss
timeFrame: 4 hours post operative
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: AswanUH
Study officials:
References:
citation: 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.