The Comparison of the Effect of Different Oxytocin Administrations on the Blood Loss During Cesarean Delivery

Study Overview
=================
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.

Official Title
-----------------
The Comparison of the Effect of Different Oxytocin Administrations on the Blood Loss During Cesarean Delivery: a Randomised Controlled Trial

Conditions
-----------------
Cesarean Section Complications, Postpartum Hemorrhage, Blood Loss, Surgical, Blood Loss, Postoperative, Postoperative Pain, Atony, Uterine

Intervention / Treatment
-----------------
* Other: before uterine incision oxytocin
* Other: after clamping the umbilical cord oxytocin


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: before uterine incision oxytocin group<br>IV infusion of 20 IU of oxytocin started before uterine incision | Other: before uterine incision oxytocin<br>* blood loss during elective cesarean section<br>|
| Active Comparator: after clamping the umbilical cord oxytocin group<br>IV infusion of 20 IU of oxytocin started immediately after clamping the umbilical cord | Other: after clamping the umbilical cord oxytocin<br>* blood loss during elective cesarean section<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative blood loss | The hemoglobin and hematocrit values will be measured 24 hours after CS | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oxytocin, cesarean section, uterine atony, Postpartum Hemorrhage