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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Complications; Cesarean Section

Intervention / Treatment
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* Procedure: manual removal
* Procedure: cord traction


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: manual removal group<br>Group will be assigned for manual removal of the placenta as 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 by caesarean section | Procedure: manual removal<br>* 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<br>|
| Experimental: cord traction group<br>Group will be assigned for controlled cord traction as the surgeon do external uterine massage and gentle traction on the exposed umbilical cord to facilitate placental delivery after the delivery of the baby by caesarean section | Procedure: cord traction<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Duration of operation | time calculated from first skin incision to the time of last stitch | 2 hours | 
| Need to use ecbolics | documentation of the type, the dose of different ecbolics needed to stop any possible bleeding | 30 minutes | 
| 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 | 
| Blood loss > 1000 ml | counting down the cases of estimated blood loss more than 1000ml | 12 hours | 
| postoperative endometritis and puerperal pyrexia | counting down the cases of puerperal pyrexia after exclusion of all other etiologies rather than endometritis | one week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood loss, caesarean section, placental delivery