Clinical trial NCT03124472: Effect of Uterine Artery Ligation Prior to Uterine Incision in Women With Placenta Previa
Official title: Effect of Uterine Artery Ligation Prior to Uterine Incision in Women With Placenta Previa
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Placenta Previa
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-04-21
Enrollment: 200
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Pfannenstiel incision of skin and opening of the anterior abdominal wall in layers.

* The loose peritoneum of the lower uterine segment is dissected downwards to mobilize the urinary bladder and expose the lower uterine segment.
* Uterine artery ligation was performed by grasping the broad ligament with thumb anterior and the index finger lifting the base below the site uterine incision; the uterine artery was singly ligated with No. 1 vicryl suture. Myometrium was included so that uterine vessels are not damaged.
* Cresenteric lower uterine segment incision was performed as usual. Higher incisions were performed in cases where the traditional incision was expected to be directly through the placenta Delivery of the baby and placenta.
* Closure of the uterine incision in 2 layers with N0. 1 vicryl suture.
* Closure of the anterior abdominal wall in layers

Detailed description: Pfannenstiel incision of skin and opening of the anterior abdominal wall in layers.

* The loose peritoneum of the lower uterine segment is dissected downwards to mobilize the urinary bladder and expose the lower uterine segment.
* Uterine artery ligation was performed by grasping the broad ligament with thumb anterior and the index finger lifting the base below the site uterine incision; the uterine artery was singly ligated with No. 1 vicryl suture. Myometrium was included so that uterine vessels are not damaged.
* Cresenteric lower uterine segment incision was performed as usual. Higher incisions were performed in cases where the traditional incision was expected to be directly through the placenta Delivery of the baby and placenta.
* Closure of the uterine incision in 2 layers with N0. 1 vicryl suture.
* Closure of the anterior abdominal wall in layers In the control group, lower segment caesarean section is without uterine artery ligation

Eligibility criteria: Inclusion Criteria:

* patients diagnosed with placenta praevia antenatally
* plan is elective caesarean section
* Gestational age \>34 weeks

Exclusion Criteria:

* Fetal distress
* medical disorders as hypertension or Diabetes Mellitus
* Coagulation defects.
* Emergency Cesarean section
* women with antepartum hemorrhage
* patients with marked ahdesions or those with non possible uterine artery ligation

Primary outcomes:
measure: Decrease in Hemoglabin level
timeFrame: 24 hours after Cesarean
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: Kasr Alainy medical school
name: Ahmed Maged, MD
role: PRINCIPAL_INVESTIGATOR
References: