Recruiting

Oxytocin Bolus & Infusion

Sponsor:

Stony Brook University

Code:

NCT05236985

Conditions

Elective Cesarean Section

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Oxytocin bolus or oxytocin infusion

Study Details

Brief summary:

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

Conditions

Elective Cesarean Section

Study ID

NCT05236985

Start date

Mar 15, 2022

Status verified date

Mar, 2024

Completion date

Dec 15, 2024

Anticipated

Primary completion date

Dec 15, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Bolus arm

Patients will receive 3 IU oxytocin IV bolus over 15 seconds after delivery of the baby/uterine cord clamping and a maintenance infusion of 0.9% Saline will be started at 225ml/hr. If uterine tone is inadequate after 3 minutes, a second bolus of 3 IU oxytocin will be given. If uterine tone is inadequate after an additional 3 minutes, a third bolus of 3 IU Oxytocin IV is given over 15 seconds. If after an additional 3 mins uterine tone is still inadequate, a second infusion consisting of oxytocin 3 IU/hr is started at 100ml/hrs and continued for a total of 4 hours, second line uterotonic agents (Methergine, Hemabate and/ or Cytotec) will be given, and the maintenance 0.9% Saline infusion will be changed to 450 ml/hr for a total of 1 hour, then changed to 38 ml/ hour for the following 3 hours. If uterine tone is considered adequate at 3, 6 or 9 minutes, a second infusion of oxytocin 3 IU/hr (100ml/hr) is started and maintained for 4 hours.

active comparator: Infusion arm

Patients will receive a bolus of IV 0.9% Saline over 15 seconds after delivery of the baby/uterine cord clamping and a maintenance infusion of 18 IU/hr Oxytocin IV (225ml/hr). If uterine tone is inadequate after 3 minutes, a second bolus of 0.9% Saline will be given. If uterine tone is inadequate after another 3 minutes, a third bolus of 0.9% Saline will be given. If after another 3 mins uterine tone is inadequate, a second infusion of 0.9% Saline will be started for 4 hours, second line uterotonic agents (Methergine, Hemabate and/or Cytotec) will be given, and the Oxytocin infusion will be changed to 36 IU/hour (450 ml/hr) for a total of 1 hour, and then changed to 38 ml/hr for the following 3 hours. If uterine tone is considered adequate at 3, 6 or 9 minutes, a second infusion of 0.9% Saline at 100 ml/hr will be started and maintained for 4 hours, along with the maintenance infusion of 18 IU/hr (225 ml/ hr) for a total of 1 hour, then changed to 38 ml/hr for an additional 3 hours.

Interventions

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.

Primary outcome measure

  • Number/Proportion of Participants with Adequate Uterine tone [ Time Frame: 2 minutes ]

Central Contacts and Locations

Central contacts

Tifany E Angelo, DO

631-444-2975mailto:Tiffany.Angelo@stonybrookmedicine.edu

Ayesha Khan

6314447339ayesha.khan@stonybrookmedicine.edu

Locations

Stony Brook University

Recruiting

Stony Brook, New York, United States, 11794-8167

Contacts

Ayesha Kham

631-444-7339ayesha.khan@stonybrookmedicine.edu

TIFFANY ANGELO, DO

6314442975Tiffany.Angelo@stonybrookmedicine.edu

More Information

Sponsor

Stony Brook University

Last update posted

Mar 15, 2024

Last verified

Mar, 2024

Keywords

  • Oxytocin, bolus, infusion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stony Brook University on 2024-03-15.