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Completed

NCT Number: NCT03344302

Oxytocin Administration During Cesarean Section

Cesarean delivery is defined as fetal birth through incisions in the abdominal wall and the uterine wall. This definition does not include removal of the fetus from the abdominal cavity in the case of uterine rupture or in the case of an abdominal pregnancy The guidelines of the Royal College of Obstetricians and Gynaecologists on caesarean section recommend a slow intravenous bolus dose of 5 IU of oxytocin after delivery of the infant. Intravenous oxytocin has a short half life (4-10 minutes); therefore the potential advantage of an oxytocin infusion at caesarean section is in maintaining uterine contractility throughout the surgical procedure and immediate postpartum period, when most primary haemorrhage occurs

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Key information

Conditions

Postpartum Hemorrhage Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Assiut Faculty of Medicine

Asyut, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Primigravida or multigravida
  • Term (37 - 42 weeks),
  • Singleton pregnancies
  • Booked for elective caesarean section.
  • Accepting to participate in the study.

Exclusion criteria

  • • Medical disorders involving the heart, liver, kidney or brain.
  • Diabetes mellitus and hypertension.
  • Blood disorders (e.g. coagulopathies, thrombocytopenia)
  • Patients requiring blood transfusion due to anemia.
  • Risk factors for uterine atony e.g. macrosomia, polyhydramnios and multiple pregnancy.
  • Previous 2 or more cesarean section
  • Placenta previa or placental abruption
  • Previous major obstetric haemorrhage (>1000 ml) in previous deliveries.
  • Known fibroid or adenomyosis.
  • Women who received anticoagulant therapy.
  • Severe preeclampsis.
  • Uterine anomalies.

Treatment and study plan

Oxytocin

Drug

intravenous infusion of oxytocin 30 units over 5 minutes diluted into 500 mL of normal 0.9% sodium chloride

Primary outcomes

  1. rate of blood loss

    Time frame: 4 hours

    collection of the blood in the drape below the patient

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Oxytocin Administration During Cesarean Section Before Versus After Fetal Delivery Randomized Clinical Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 17, 2017
Registry last updated
Apr 23, 2018

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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