The Comparison of the Effect of Different Oxytocin Administrations on the Blood Loss During Cesarean Delivery
Primary Purpose
Cesarean Section Complications, Postpartum Hemorrhage, Blood Loss, Surgical
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
before uterine incision oxytocin
after clamping the umbilical cord oxytocin
Sponsored by
About this trial
This is an interventional treatment trial for Cesarean Section Complications focused on measuring Oxytocin, cesarean section, uterine atony, Postpartum Hemorrhage
Eligibility Criteria
Inclusion Criteria:
- single fetus at term >37 weeks of gestational age
Exclusion Criteria:
- history of previous cesarean section
- history of previous uterine surgery
- multiple gestation, placenta previa, polyhydramnious, fetal macrosomia
- women at high risk for uterine atony such as anemia (Hb < 8 gm/dL)
- uterine atony history
- gestational diabetes mellitus, gestational hypertension, preeclampsia, current or previous history of heart disease, liver, renal disorders or known coagulopath
Sites / Locations
- Bezmialem Vakıf University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
before uterine incision oxytocin group
after clamping the umbilical cord oxytocin group
Arm Description
IV infusion of 20 IU of oxytocin started before uterine incision
IV infusion of 20 IU of oxytocin started immediately after clamping the umbilical cord
Outcomes
Primary Outcome Measures
blood loss during elective cesarean section
The intraoperative blood loss will be measured by adding the volume of the suction bottle with the blood soaked sponges (know dry weight). The blood loss was estimated after excluded amniotic fluid volume in the suction bottle in each case
Secondary Outcome Measures
postoperative blood loss
The hemoglobin and hematocrit values will be measured 24 hours after CS
Full Information
NCT ID
NCT03967171
First Posted
May 27, 2019
Last Updated
September 23, 2019
Sponsor
Bezmialem Vakif University
1. Study Identification
Unique Protocol Identification Number
NCT03967171
Brief Title
The Comparison of the Effect of Different Oxytocin Administrations on the Blood Loss During Cesarean Delivery
Official Title
The Comparison of the Effect of Different Oxytocin Administrations on the Blood Loss During Cesarean Delivery: a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
June 20, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bezmialem Vakif University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study compares the effect of starting intravenous oxytocin infusion early before uterine incision versus late after umbilical cord clamping on the blood loss during elective cesarean section
Detailed Description
Postpartum hemorrhage (PPH) is still the major cause of maternal morbidity and mortality worldwide contributing to nearly 25% of direct maternal deaths. The average blood loss during cesarean section is 1000 ml which is nearly double the blood loss during vaginal delivery. Worldwide, the most commonly used uterotonic for the prevention of PPH is oxytocin. Several regimens of oxytocin have been tested during cesarean section with variable wanted (uterotonic) and unwanted (cardiovascular) effects. In the current study, we tested the hypothesis that initiating IV oxytocin infusion earlier before uterine incision would induce a rapid acceptable uterine contraction and minimize the intraoperative blood loss than the same dose administered after delivery of the fetus.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section Complications, Postpartum Hemorrhage, Blood Loss, Surgical, Blood Loss, Postoperative, Postoperative Pain, Atony, Uterine
Keywords
Oxytocin, cesarean section, uterine atony, Postpartum Hemorrhage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
before uterine incision oxytocin group
Arm Type
Experimental
Arm Description
IV infusion of 20 IU of oxytocin started before uterine incision
Arm Title
after clamping the umbilical cord oxytocin group
Arm Type
Active Comparator
Arm Description
IV infusion of 20 IU of oxytocin started immediately after clamping the umbilical cord
Intervention Type
Other
Intervention Name(s)
before uterine incision oxytocin
Intervention Description
blood loss during elective cesarean section
Intervention Type
Other
Intervention Name(s)
after clamping the umbilical cord oxytocin
Intervention Description
blood loss during elective cesarean section
Primary Outcome Measure Information:
Title
blood loss during elective cesarean section
Description
The intraoperative blood loss will be measured by adding the volume of the suction bottle with the blood soaked sponges (know dry weight). The blood loss was estimated after excluded amniotic fluid volume in the suction bottle in each case
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
postoperative blood loss
Description
The hemoglobin and hematocrit values will be measured 24 hours after CS
Time Frame
24 hours
Other Pre-specified Outcome Measures:
Title
postoperative pain score
Description
The Visual Analogue Scale (VAS) will be implemented postoperative day 0 and postoperative 1st day
Time Frame
24 hours
Title
neonatal wellbeing
Description
Apgar scores (1 and 5 minutes) will be compared
Time Frame
2 hours
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
single fetus at term >37 weeks of gestational age
Exclusion Criteria:
history of previous cesarean section
history of previous uterine surgery
multiple gestation, placenta previa, polyhydramnious, fetal macrosomia
women at high risk for uterine atony such as anemia (Hb < 8 gm/dL)
uterine atony history
gestational diabetes mellitus, gestational hypertension, preeclampsia, current or previous history of heart disease, liver, renal disorders or known coagulopath
Facility Information:
Facility Name
Bezmialem Vakıf University Hospital
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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The Comparison of the Effect of Different Oxytocin Administrations on the Blood Loss During Cesarean Delivery
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