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

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ClinicalTrials.gov Identifier: NCT03967171
Recruitment Status : Recruiting
First Posted : May 30, 2019
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Bezmialem Vakif University

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

Condition or disease Intervention/treatment Phase
Cesarean Section Complications Postpartum Hemorrhage Blood Loss, Surgical Blood Loss, Postoperative Postoperative Pain Atony, Uterine Other: before uterine incision oxytocin Other: after clamping the umbilical cord oxytocin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Comparison of the Effect of Different Oxytocin Administrations on the Blood Loss During Cesarean Delivery: a Randomised Controlled Trial
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : June 20, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: before uterine incision oxytocin group
IV infusion of 20 IU of oxytocin started before uterine incision
Other: before uterine incision oxytocin
blood loss during elective cesarean section

Active Comparator: after clamping the umbilical cord oxytocin group
IV infusion of 20 IU of oxytocin started immediately after clamping the umbilical cord
Other: after clamping the umbilical cord oxytocin
blood loss during elective cesarean section




Primary Outcome Measures :
  1. blood loss during elective cesarean section [ Time Frame: 2 hours ]
    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 :
  1. postoperative blood loss [ Time Frame: 24 hours ]
    The hemoglobin and hematocrit values will be measured 24 hours after CS


Other Outcome Measures:
  1. postoperative pain score [ Time Frame: 24 hours ]
    The Visual Analogue Scale (VAS) will be implemented postoperative day 0 and postoperative 1st day

  2. neonatal wellbeing [ Time Frame: 2 hours ]
    Apgar scores (1 and 5 minutes) will be compared



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03967171


Contacts
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Contact: taha takmaz, MD +902124531700 thtkmz@hotmail.com
Contact: pinar ozcan, MD +902124531700 drpinarozcan@hotmail.com

Locations
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Turkey
Bezmialem Vakıf University Hospital Recruiting
Istanbul, Turkey, 34093
Sponsors and Collaborators
Bezmialem Vakif University

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Responsible Party: Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT03967171     History of Changes
Other Study ID Numbers: BezmialemVU Oxytocin effect
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bezmialem Vakif University:
Oxytocin
cesarean section
uterine atony
Postpartum Hemorrhage

Additional relevant MeSH terms:
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Hemorrhage
Postpartum Hemorrhage
Blood Loss, Surgical
Postoperative Hemorrhage
Uterine Hemorrhage
Pain, Postoperative
Uterine Inertia
Pathologic Processes
Postoperative Complications
Pain
Neurologic Manifestations
Signs and Symptoms
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Intraoperative Complications
Dystocia
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs