Methods of Placental Delivery and the Amount of Blood Loss During Cesarean Section

Complications; Cesarean Section Clinical Trial

Official title:

How Can Methods of Placental Delivery Affect the Amount of Blood Loss During Cesarean Section?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02405663
• Other study ID #: afhsr-1-3-2015
• Status: Completed
• Phase: N/A
• First received: March 18, 2015
• Last updated: May 24, 2017
• Start date: April 2015
• Est. completion date: July 2016

Study information

• Verified date: May 2017
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Complications; Cesarean Section
• Hemorrhage

Intervention

Procedure:
• manual removal
one of the standard procedures for placental delivery during caesarean section the surgeon will introduce his hand into the uterine cavity to cleave the placenta from the decidua basalis as soon as possible after the delivery of the baby
• cord traction
one of the standard procedures for placental delivery during caesarean section the surgeon do external uterine massage and gentle traction on the exposed umbilical cord to facilitate placental delivery

Locations

Country	Name	City	State
Saudi Arabia	Postpartum ward of Armed Forces Hospital, Southern Region	Khamis Mushait,	Asir,

Sponsors (2)

Lead Sponsor	Collaborator
Benha University	Armed Forces Hospitals, Southern Region, Saudi Arabia

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood loss assessment after placental delivery	Determine estimated blood loss after placental delivery either by cord traction or manually during caesarean section through comparing pre and postoperative hemoglobin and haematocrit measurements	12 hours
Secondary	Placental delivery time.	time needed to deliver the placenta calculated from time of full baby delivery to the time of full placental delivery	30 minutes
Secondary	Duration of operation	time calculated from first skin incision to the time of last stitch	2 hours
Secondary	Need to use ecbolics	documentation of the type, the dose of different ecbolics needed to stop any possible bleeding	30 minutes
Secondary	Need of blood transfusion	documentation of the need and the amount needed of packed red blood cells packs or any other blood products if patient general condition required	12 hours
Secondary	Blood loss > 1000 ml	counting down the cases of estimated blood loss more than 1000ml	12 hours
Secondary	postoperative endometritis and puerperal pyrexia	counting down the cases of puerperal pyrexia after exclusion of all other etiologies rather than endometritis	one week