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NCT Number: NCT03967171

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

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

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Key information

Conditions

Cesarean Section Complications Atony, Uterine Blood Loss, Postoperative Blood Loss, Surgical Dystocia Female Urogenital Diseases and Pregnancy Complications Hemorrhage Intraoperative Complications Neurologic Manifestations Obstetric Labor Complications Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Hemorrhage Postoperative Pain Postpartum Hemorrhage Pregnancy Complications Puerperal Disorders Signs and Symptoms Urogenital Diseases Uterine Hemorrhage Uterine Inertia

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakıf University Hospital

Istanbul, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

before uterine incision oxytocin

Other

blood loss during elective cesarean section

after clamping the umbilical cord oxytocin

Other

blood loss during elective cesarean section

Primary outcomes

  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 outcomes

  1. postoperative blood loss

    Time frame: 24 hours

    The hemoglobin and hematocrit values will be measured 24 hours after CS

Other outcomes

  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

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 30, 2019
Registry last updated
Sep 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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