Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this randomized, double-blind clinical trial is to learn if Oxytocin is most effective at achieving adequate uterine tone (important for preventing postpartum hemorrhage) when administered as a bolus or an infusion in patients at high-risk for postpartum hemorrhage in elective cesarean sections. The main questions that will be answered are:
3. Are patients more satisfied with their cesarean section when they receive Oxytocin bolus or Oxytocin infusion?
Researchers will compare the 2 methods of Oxytocin administration, bolus versus infusion, to see which method is more effective or if they are equally effective.
Participants will:
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. A prior study was conducted at Stony Brook University Hospital which investigated the difference between bolus versus infusion administration of oxytocin in elective cesarean section patients with a low risk of postpartum hemorrhage (PPH); the results of this randomized, double blinded clinical trial showed that bolus was not superior for adequate uterine tone at 2 minutes when compared to infusion of oxytocin, but blood loss was modestly lower and total oxytocin exposure was substantially lower in the bolus arm. Which makes the most logical next question: Does bolus oxytocin become more clinically meaningful in patients with higher baseline risk for uterine atony or hemorrhage. The investigators aim to address this question with the INBOX-HR study.
INBOX-HR acts as a continuing investigation on the difference between bolus versus infusion administration of oxytocin, specifically for patients that are at a high risk for postpartum hemorrhage. Thus, the purpose of this research study is to compare bolus and infusion administration of oxytocin on parturients at high risk for postpartum hemorrhage undergoing elective cesarean section. The primary objective of this study is to test the hypothesis that administration by bolus vs. infusion results in more rapid achievement of adequate uterine tone in this patient population. Secondary objectives include determining estimated blood loss, prevalence of hypotension, change in heart rate, nausea, vomiting, and patient satisfaction, and 0 - 10 uterine tone score.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxytocin Bolus | Active Comparator | Patients in the bolus arm will receive a 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 considered inadequate after an additional 3 minutes, a second bolus of 3 IU oxytocin is given IV over 15 seconds. 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 |
|
| Oxytocin Infusion | Active Comparator | Patients in the infusion arm 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 considered inadequate after an additional 3 minutes, a second bolus of 0.9% Saline will be given IV over 15 seconds. If uterine tone is inadequate after an additional 3 minutes, a third bolus of 0.9% Saline will be given IV over 15 seconds. If after an additional 3 mins uterine tone is still inadequate, a second infusion of 0.9% Saline will be started at 100 ml/hr 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin Bolus or Oxytocin Infusion | Drug | On the day of surgery, patients will be randomized to receive either bolus or infusion administration of Oxytocin. On the day of the procedure, periprocedural data and patient satisfaction (single question) will be recorded. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to uterine tone | Uterine tone will be assessed at 2 mins and then every minute thereafter until adequate uterine tone is attained but no more than 10 minutes maximum, by a blinded obstetrician. Uterine tone will be deemed adequate or inadequate by the blinded obstetrician. The time for the primary endpoint analysis is adequacy of uterine tone at 2 minutes after the baby is born/umbilical cord clamped. | 2 minutes after umbilical cord clamp until 10 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated intraoperative blood loss | From the start to end of surgery | |
| Changes in heart rate (beats per minute) | During uterine cord clamp and every 2 minutes thereafter until 10 minutes | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tiffany E Angelo, DO, FASA | Contact | 631-759-0328 | tiffany.angelo@stonybrookmedicine.edu | |
| Anna E Suske | Contact | 631-317-8420 | anna.suske@stonybrookmedicine.edu |
| Name | Affiliation | Role |
|---|---|---|
| Tiffany E Angelo, DO, FASA | Stony Brook University Hospital Department of Anesthesiology | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37576820 | Background | Wang LY, Wang J, Dong JH, Ping ZP, Chen XZ, Wei CN. The optimal oxytocin infusion rate for preventing uterine atony during cesarean delivery in elderly parturients with prior history of cesarean delivery. Front Pharmacol. 2023 Jul 28;14:1211693. doi: 10.3389/fphar.2023.1211693. eCollection 2023. | |
| 20142652 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Randomized, double-blinded, 2-arm, parallel study.
Not provided
Not provided
Not provided
| Changes in blood pressure (mmHg) |
| During uterine cord clamp and every 2 minutes thereafter until 10 minutes. |
| Total dose of phenylephrine administered intraoperatively | From the start to end of surgery |
| Need for additional uterotonic agents | Such as Methergine, Hemabate, and Cytotec | From oxytocin administration until end of surgery |
| 0-10 Uterine tone score | Uterine tone score will be assessed at 2 mins and then every minute thereafter. | 2 minutes after uterine cord clamping until 10 minutes. |
| Maternal side effects | Chest pain, nausea, vomiting | From oxytocin administration until end of surgery |
| Patient satisfaction questionnaire | The patient will be asked a question about their experience on a scale of 0-10 (0 being complete dissatisfaction, and 10 being highly satisfied). | 2 hours after surgery |
| Oyelese Y, Ananth CV. Postpartum hemorrhage: epidemiology, risk factors, and causes. Clin Obstet Gynecol. 2010 Mar;53(1):147-56. doi: 10.1097/GRF.0b013e3181cc406d. |
| 33487681 | 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. |
| 6093538 | 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. |
| 29151071 | 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. |
| 24667448 | 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. |
| 25103301 | Background | 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. |
| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| D014593 | Uterine Inertia |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004420 | Dystocia |
Not provided
Not provided