Clinical trial NCT02405663: Methods of Placental Delivery and the Amount of Blood Loss During Cesarean Section
Official title: How Can Methods of Placental Delivery Affect the Amount of Blood Loss During Cesarean Section?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complications; Cesarean Section
Keywords: blood loss
caesarean section
placental delivery
Lead sponsor: Benha University
Sponsor class: OTHER
Collaborators: name: Armed Forces Hospitals, Southern Region, Saudi Arabia
First posted: 2015-04-01
Enrollment: 288
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To compare between the effect of controlled cord traction and manual removal of the placenta on blood loss among women undergoing caesarean sections

Detailed description: Cesarean section (CS) is one of the most commonly performed major abdominal operations in women worldwide and its rate is increasing dramatically every year.

Some of the reported short-term morbidities include hemorrhage, postoperative fever and endometritis. The method of delivering the placenta is one procedure that may contribute to an increase or decrease in the morbidity of CS.

On an average 0.5-1 liter of blood is lost during CS, many variable techniques have been tried to reduce this blood loss. Such techniques include finger splitting versus scissor cutting of incision, in situ stitching verses exteriorization and stitching of uterus , and finally spontaneous or manual removal of the placenta.

Two common methods used to deliver the placenta at CS are cord traction and manual removal.

Manual removal of the placenta which the obstetrician introduce his hand into the uterine cavity to cleave the placenta from the decidua basalis as soon as possible after the delivery of the infant and controlled cord traction in which the obstetrician do external uterine massage and gentle traction on the exposed umbilical cord to facilitate placental delivery.

Opinions differ about the best for placental delivery technique at CS. Some trials showed a reduced risk of blood loss with controlled cord traction (3) and others showed that manual removal of placenta at CS do not increase perioperative blood loss.

Authors concluded that manual delivery of the placenta was significantly associated with greater operative blood loss and greater decrease in postoperative hemoglobin levels and postpartum maternal infectious morbidity but with shorter operative time compared with spontaneous placental separation .

In addition, it is known that the blood loss at CS delivery is difficult to estimate, and numerous different methods including serial change in hematocrit (Hct), hemoglobin (Hb) level, visual estimation and the gravimetric method are described.

A low, but significant, correlation was found between visually estimated blood loss and perioperative hemoglobin change in women delivering by CS. However, hemoglobin , hematocrit levels and visual estimation are the most commonly used technique for estimating blood loss at delivery.

Eligibility criteria: Inclusion Criteria:

- All informed and consented women undergoing elective or emergency CS will be legible for enrollment into the study

Exclusion Criteria:

* Multiple gestation.
* Pregnancy below 34 weeks.
* Severe maternal anemia.
* Severe pre-eclampsia
* Prolonged labor.
* Prolonged rupture of the membranes with fever.
* Placental abruption.
* Placenta previa.
* Placenta accreta.
* Clotting disorders.
* Current or previous history of a significant disease including heart disease, liver, renal disorders.

Primary outcomes:
measure: blood loss assessment after placental delivery
timeFrame: 12 hours
Secondary outcomes:
measure: Placental delivery time.
timeFrame: 30 minutes
measure: Duration of operation
timeFrame: 2 hours
measure: Need to use ecbolics
timeFrame: 30 minutes
measure: Need of blood transfusion
timeFrame: 12 hours
measure: Blood loss > 1000 ml
timeFrame: 12 hours
measure: postoperative endometritis and puerperal pyrexia
timeFrame: one week
Other outcomes:
Locations:
city: Khamis Mushait,
country: Saudi Arabia
facility: Postpartum ward of Armed Forces Hospital, Southern Region
state: Asir,
Study officials:
affiliation: Ain Shams University
name: mohammed ellaithy
role: PRINCIPAL_INVESTIGATOR
affiliation: Zagazig University
name: haytham atia
role: PRINCIPAL_INVESTIGATOR
affiliation: Armed Forces Hospitals, Southern Region, Saudi Arabia
name: nuzhat amer
role: PRINCIPAL_INVESTIGATOR
affiliation: Benha University
name: ahmed altraigey
role: STUDY_DIRECTOR
References: