Oxytocin Bolus Versus Infusion in Elective Cesarean Section"

NCT05236985 | Recruiting Phase 4 FDA Drug

• 1 other identifier: IRB 2021-00558
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Elective Cesarean Section

Keywords

Oxytocin, bolus, infusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient satisfaction questionnaire (Scale 0 to 10, 0 being complete dissatisfaction and 10 being highly satisfied

  2± 1 hours after surgery

Study Arms (2)

Bolus arm

ACTIVE COMPARATOR

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.

Drug: Oxytocin bolus or oxytocin infusion

Infusion arm

ACTIVE COMPARATOR

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.

Drug: Oxytocin bolus or oxytocin infusion

Interventions

Oxytocin bolus or oxytocin infusion DRUG

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.

Bolus arm; Infusion arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

Stony Brook University

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

RECRUITING

Related Publications (5)

• 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.

  PMID: 25103301 BACKGROUND

• 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.

  PMID: 24667448 BACKGROUND

• 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.

  PMID: 29151071 BACKGROUND

• 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.

  PMID: 6093538 BACKGROUND

• 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.

  PMID: 33487681 BACKGROUND

Study Officials

• Tiffany E Angelo, DO

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tifany E Angelo, DO

CONTACT

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

Ayesha Khan

CONTACT

6314447339; ayesha.khan@stonybrookmedicine.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Division Chief: Women's Anesthesiology

Model Details: Randomized, double-blinded, 2-arm, parallel study.

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: February 11, 2022
• Study Start: March 15, 2022
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)