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Completed

NCT Number: NCT01932060

Oxytocin Infusions and Blood Loss in Patients Undergoing Elective Cesarean Delivery.

Although prior dose-finding studies have investigated the optimal bolus dose of oxytocin to initiate adequate uterine tone, it is unclear what oxytocin infusion regimen is required to maintain adequate uterine tone after delivery. The study investigators aim to compare two different infusion rates of oxytocin to assess the optimal infusion regimen for reducing blood loss in women undergoing elective Cesarean delivery.

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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

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Lucile Packard Children's Hospital, Stanford University

Stanford, California, 94305, United States

About this study

Oxytocin (pitocin) is a drug commonly used in obstetric practice, and the drug effect is to increase the muscular tone of the uterus to reduce uterine bleeding after neonatal delivery. Pregnant patients undergoing elective (scheduled)Cesarean delivery routinely receive oxytocin after delivery of the baby. Post-delivery, oxytocin is commonly administered as an IV bolus and/or infusion. No previous studies have accurately assessed differences in oxytocin infusions after delivery in patients undergoing elective cesarean delivery. Thus the study aim is to investigate which infusion rate can optimally provide adequate maintenance of uterine tone during Cesarean delivery while being associated with minimal or no maternal side-effects.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy pregnant patients with uncomplicated pregnancies:
  • ASA (American Association of Anesthesiologists) class 1 or 2 patients.
  • Singleton pregnancies.

Exclusion criteria

  • ASA class 3 or 4 patients.
  • Known drug allergy to intravenous oxytocin.
  • Significant medical or obstetric disease.
  • Known uterine abnormality.
  • Known placental abnormality.

Treatment and study plan

Oxytocin Infusion

Drug

Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit.

Other names: Oxytocin; Pitocin

Primary outcomes

  1. Total Estimated Blood Loss

    Time frame: immediately at end of surgery

    Blood loss will be measured volumetrically (based on measured volume of blood within the suction chamber) and gravimetrically (based on blood weight on blood soaked laps).

Secondary outcomes

  1. Hemoglobin Indices After Cesarean Delivery

    Time frame: 24 hr after cesarean delivery

    Study investigators will assess maternal hemoglobin levels at 24hr after cesarean delivery

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Effects of Different Oxytocin Infusions on Blood Loss and Postpartum Hemoglobin Values in Patients Undergoing Elective Cesarean Delivery

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Aug 30, 2013
Registry last updated
Feb 1, 2017

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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