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Completed

NCT Number: NCT01630187

Comparison of Two Doses of Carbetocin for Prevention of Uterine Atony, During Elective Cesarean Section

The purpose of this study is to evaluate the effectiveness of two doses of carbetocin (50 mcg vs 100 mcg) in preventing uterine atony during elective cesarean section.

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Key information

Conditions

Uterine Atony Dystocia Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Post-partum Hemorrhage Postpartum Hemorrhage Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage Uterine Inertia

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hôpital Saint-François-d'Assise (CHUQ)

Québec, Quebec, G1L 3L5, Canada

About this study

Postpartum hemorrhage is a major cause of mortality and morbidity in the world, and it is most often caused by uterine atony. To prevent this complication, uterotonic medication is used during elective cesarean section.

Carbetocin, a long-acting synthetic analogue of oxytocin, has been used for this purpose for many years. This medication has numerous side effects: hypotension, tachycardia, nausea, vomiting, chest pain, etc. Using a smaller dose of carbetocin might lower the incidence of these side effects, without compromising prevention of uterine atony in a low-risk group of patient.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ≥ 18 years old
  • ≥ 37-week pregnancy
  • singleton pregnancy
  • elective cesarean section with a low transverse incision
  • ASA I or II

Exclusion criteria

  • Personal history of uterine atony or postpartum hemorrhage
  • Abnormal placental implantation (known or suspected)
  • > 3 cesarean sections in the past
  • Personal history of a classic uterine incision
  • Estimated fetal weight > 4500g
  • Hemoglobin < 100 g/L
  • Regular use of tocolytic drugs
  • Cesarean section under general anesthesia
  • Known allergy to carbetocin
  • Refusal
  • Inability to obtain informed consent

Treatment and study plan

Carbetocin

Drug

Administration of carbetocin 50 mcg , after clamping the umbilical cord

Primary outcomes

  1. Utilization of a second uterotonic drug

    Time frame: First 48 hours of the postpartum

Secondary outcomes

  1. Incidence of side effects

    Time frame: During the fifteen minutes following the administration of carbetocin

  2. Incidence of major complications

    Time frame: First 48 hours of the postpartum

  3. Drop in hemoglobin measurement

    Time frame: on the second post-partum day

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Official study title

Comparison of Two Doses of Carbetocin for Prevention of Uterine Atony During Elective Cesarean Section: a Randomized Controlled Trial

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 28, 2012
Registry last updated
May 29, 2013

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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