- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02405663
Methods of Placental Delivery and the Amount of Blood Loss During Cesarean Section
How Can Methods of Placental Delivery Affect the Amount of Blood Loss During Cesarean Section?
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Asir,
-
Khamis Mushait,, Asir,, Saudi Arabia, 101
- Postpartum ward of Armed Forces Hospital, Southern Region
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: manual removal group
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
|
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
|
Experimental: cord traction group
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
blood loss assessment after placental delivery
Time Frame: 12 hours
|
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 Frame: 30 minutes
|
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 Frame: 2 hours
|
time calculated from first skin incision to the time of last stitch
|
2 hours
|
Need to use ecbolics
Time Frame: 30 minutes
|
documentation of the type, the dose of different ecbolics needed to stop any possible bleeding
|
30 minutes
|
Need of blood transfusion
Time Frame: 12 hours
|
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
Time Frame: 12 hours
|
counting down the cases of estimated blood loss more than 1000ml
|
12 hours
|
postoperative endometritis and puerperal pyrexia
Time Frame: one week
|
counting down the cases of puerperal pyrexia after exclusion of all other etiologies rather than endometritis
|
one week
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- afhsr-1-3-2015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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