Oxytocin Bolus Versus Infusion in Elective Cesarean Section"

Elective Cesarean Section Clinical Trial

— INBOX  

Official title:

Randomized Double-Blinded Clinical Trial of Oxytocin Bolus Versus Infusion in Elective Cesarean Section

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05236985
• Other study ID #: IRB 2021-00558
• Status: Recruiting
• Phase: Phase 4
• Start date: March 15, 2022
• Est. completion date: December 15, 2024

Study information

• Verified date: March 2024
• Source: Stony Brook University
• Contact: Tifany E Angelo, DO
• Phone: 631-444-2975
• Email: mailto:Tiffany.Angelo[@]stonybrookmedicine.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Bolus administration of oxytocin is superior to infusion in time to achieving adequate uterine tone.

Description:

Oxytocin is the most commonly used uterotonic agent worldwide to achieve adequate uterine tone and prevent postpartum hemorrhage. Over the past decade, the trend has been towards lowering the dose to reduce oxytocin-related adverse effects including nausea, hypotension, chest pain, EKG changes, and maternal death. However, the optimal strategy for oxytocin administration remains controversial. Prior literature found bolus doses less than 5 IU to be effective in achieving adequate uterine tone with a significant reduction in adverse side effects. There is limited high quality data comparing bolus versus infusion administration of oxytocin. The current standard of care at the institution is an infusion of oxytocin 18 IU/hour (0.3 IU/min) and has been proven to be effective in achieving adequate uterine tone. However, the time to uterine tone appears to be slightly longer (3-4 mins) with the infusion method. Given that the estimated uterine blood flow is between 500-700 mls/min, the uterus can lose a significant amount of blood per second if uterine tone is not achieved quickly. Thus, the purpose of this research study is to compare bolus and infusion administration of oxytocin on parturients undergoing elective cesarean section. The primary objective of this study is to test the hypothesis that administration by bolus (vs. standard of care infusion) results in more rapid achievement of adequate uterine tone. Secondary objectives include determining estimated blood loss, prevalence of hypotension, nausea, vomiting, and patient satisfaction.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 15, 2024
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Parturients between the ages of 18 to 45 with singleton pregnancies

• Undergoing elective cesarean section under spinal anesthesia

• American Society of Anesthesia (ASA) physical status class I or II

• Patients must be able to provide written informed consent

Exclusion Criteria:

• Parturients in labor or ruptured membranes

• Multiple gestation

• Risk factors predisposing to uterine atony (history of placenta previa, preeclampsia, diabetes mellitus macrosomia, hydramnios, bleeding diathesis, uterine fibroids)

• History of uterine atony or postpartum hemorrhage

• History of inherited or acquired coagulation disorders, thrombocytopenia (platelet count <100), or anemia (hemoglobin < 8)

• History of allergy to oxytocin

• Patients not alert and orientated to person, place, and date. Patient must have, in the investigator's opinion, the physical and mental capacity to answer survey questions

Related Conditions & MeSH terms

• Elective Cesarean Section

Intervention

Drug:
• Oxytocin bolus or oxytocin infusion
On the day of surgery, the patients will be randomized to either bolus or infusion administration of oxytocin. On the day of the procedure, periprocedural data and patient satisfaction (single question) will be recorded.

Locations

Country	Name	City	State
United States	Stony Brook University	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

References & Publications (5)

Balki M, Tsen L. Oxytocin protocols for cesarean delivery. Int Anesthesiol Clin. 2014 Spring;52(2):48-66. doi: 10.1097/AIA.0000000000000016. No abstract available. — View Citation

Fuchs AR, Fuchs F, Husslein P, Soloff MS. Oxytocin receptors in the human uterus during pregnancy and parturition. Am J Obstet Gynecol. 1984 Nov 15;150(6):734-41. doi: 10.1016/0002-9378(84)90677-x. — View Citation

Joseph J, George SK, Daniel M, Ranjan RV. A randomised double-blind trial of minimal bolus doses of oxytocin for elective caesarean section under spinal anaesthesia: Optimal or not? Indian J Anaesth. 2020 Nov;64(11):960-964. doi: 10.4103/ija.IJA_377_20. Epub 2020 Nov 1. — View Citation

Say L, Chou D, Gemmill A, Tuncalp O, Moller AB, Daniels J, Gulmezoglu AM, Temmerman M, Alkema L. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33. doi: 10.1016/S2214-109X(14)70227-X. Epub 2014 May 5. — View Citation

Terblanche N, Otahal P, Messmer A, Wright P, Patel S, Nathan K, Sharman JE. An observational cohort study of 3 units versus 5 units slow intravenous bolus oxytocin in women undergoing elective caesarean delivery. J Physiol Pharmacol. 2017 Aug;68(4):547-553. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number/Proportion of Participants with Adequate Uterine tone	Adequacy of uterine tone (yes/no) at 2 minutes after the baby is born/umbilical cord clamped.	2 minutes
Secondary	Patient satisfaction questionnaire (Scale 0 to 10, 0 being complete dissatisfaction and 10 being highly satisfied	Patients will complete a questionnaire 2± 1 hours after surgery	2± 1 hours after surgery