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

Primary Purpose

Complications; Cesarean Section

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
manual removal
cord traction
Sponsored by
Benha University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Complications; Cesarean Section focused on measuring blood loss, caesarean section, placental delivery

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Postpartum ward of Armed Forces Hospital, Southern Region

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

manual removal group

cord traction group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Placental delivery time.
time needed to deliver the placenta calculated from time of full baby delivery to the time of full placental delivery
Duration of operation
time calculated from first skin incision to the time of last stitch
Need to use ecbolics
documentation of the type, the dose of different ecbolics needed to stop any possible bleeding
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
Blood loss > 1000 ml
counting down the cases of estimated blood loss more than 1000ml
postoperative endometritis and puerperal pyrexia
counting down the cases of puerperal pyrexia after exclusion of all other etiologies rather than endometritis

Full Information

First Posted
March 18, 2015
Last Updated
May 24, 2017
Sponsor
Benha University
Collaborators
Armed Forces Hospitals, Southern Region, Saudi Arabia
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1. Study Identification

Unique Protocol Identification Number
NCT02405663
Brief Title
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

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
Collaborators
Armed Forces Hospitals, Southern Region, Saudi Arabia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complications; Cesarean Section
Keywords
blood loss, caesarean section, placental delivery

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
288 (Actual)

8. Arms, Groups, and Interventions

Arm Title
manual removal group
Arm Type
Experimental
Arm Description
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
Arm Title
cord traction group
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
manual removal
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
cord traction
Intervention Description
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
Primary Outcome Measure Information:
Title
blood loss assessment after placental delivery
Description
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
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
Placental delivery time.
Description
time needed to deliver the placenta calculated from time of full baby delivery to the time of full placental delivery
Time Frame
30 minutes
Title
Duration of operation
Description
time calculated from first skin incision to the time of last stitch
Time Frame
2 hours
Title
Need to use ecbolics
Description
documentation of the type, the dose of different ecbolics needed to stop any possible bleeding
Time Frame
30 minutes
Title
Need of blood transfusion
Description
documentation of the need and the amount needed of packed red blood cells packs or any other blood products if patient general condition required
Time Frame
12 hours
Title
Blood loss > 1000 ml
Description
counting down the cases of estimated blood loss more than 1000ml
Time Frame
12 hours
Title
postoperative endometritis and puerperal pyrexia
Description
counting down the cases of puerperal pyrexia after exclusion of all other etiologies rather than endometritis
Time Frame
one week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mohammed ellaithy
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
haytham atia
Organizational Affiliation
Zagazig University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
nuzhat amer
Organizational Affiliation
Armed Forces Hospitals, Southern Region, Saudi Arabia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
ahmed altraigey
Organizational Affiliation
Benha University
Official's Role
Study Director
Facility Information:
Facility Name
Postpartum ward of Armed Forces Hospital, Southern Region
City
Khamis Mushait,
State/Province
Asir,
ZIP/Postal Code
101
Country
Saudi Arabia

12. IPD Sharing Statement

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

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