- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07688512
Oxytocin Bolus Versus Infusion in High-Risk Patients Undergoing Elective Cesarean Section (INBOX-HR) (INBOX-HR)
Randomized Double-Blinded Clinical Trial of Oxytocin Bolus Versus Infusion in High-Risk Patients Undergoing Elective Cesarean Section
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:
- Is Oxytocin bolus more effective than Oxytocin infusion at achieving adequate uterine tone at 2 minutes after the baby is born and every minute thereafter?
- Does Oxytocin bolus cause less maternal side effects than Oxytocin infusion?
- Does Oxytocin bolus result in less blood loss than Oxytocin infusion in high risk for postpartum hemorrhage patients undergoing elective cesarean sections?
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:
- Be randomized to receive either Oxytocin bolus or Oxytocin infusion during their cesarean section but after the baby is born.
- Be asked a question about their experience 2 hours after the surgery.
- Allow the research team to collect information about how they are doing from their hospital medical records.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 4
Kontakty a umístění
Studijní kontakt
- Jméno: Tiffany E Angelo, DO, FASA
- Telefonní číslo: 631-759-0328
- E-mail: tiffany.angelo@stonybrookmedicine.edu
Studijní záloha kontaktů
- Jméno: Anna E Suske
- Telefonní číslo: 631-317-8420
- E-mail: anna.suske@stonybrookmedicine.edu
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Undergoing elective cesarean section under spinal anesthesia or combined spinal anesthesia (CSE)
- Patients must be able to provide written informed consent in either English or Spanish
- Parturient classified as high risk for postpartum hemorrhage as defined by the adapted California Maternal Quality Care Obstetric Hemorrhage Risk Screen
Exclusion Criteria:
- Parturient in labor or ruptured membranes
- Patient does not possess the physical and mental capacity to provide informed consent
- Urgent or emergent cesarean sections
- Patients with a known major coagulopathy
- Patients with significant thrombocytopenia limiting neuraxial anesthesia (<70k)
- Patients on therapeutic anticoagulation at time of procedure
- Patients on the placenta accreta spectrum
- Patients with severe cardiac disease contraindicating oxytocin
- Patients with an allergy to oxytocin
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: Oxytocin Bolus
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
|
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. |
|
Aktivní komparátor: Oxytocin Infusion
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.
|
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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Time to uterine tone
Časové okno: 2 minutes after umbilical cord clamp until 10 minutes.
|
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.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Estimated intraoperative blood loss
Časové okno: From the start to end of surgery
|
From the start to end of surgery
|
|
|
Changes in heart rate (beats per minute)
Časové okno: During uterine cord clamp and every 2 minutes thereafter until 10 minutes
|
During uterine cord clamp and every 2 minutes thereafter until 10 minutes
|
|
|
Changes in blood pressure (mmHg)
Časové okno: During uterine cord clamp and every 2 minutes thereafter until 10 minutes.
|
During uterine cord clamp and every 2 minutes thereafter until 10 minutes.
|
|
|
Total dose of phenylephrine administered intraoperatively
Časové okno: From the start to end of surgery
|
From the start to end of surgery
|
|
|
Need for additional uterotonic agents
Časové okno: From oxytocin administration until end of surgery
|
Such as Methergine, Hemabate, and Cytotec
|
From oxytocin administration until end of surgery
|
|
0-10 Uterine tone score
Časové okno: 2 minutes after uterine cord clamping until 10 minutes.
|
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
Časové okno: From oxytocin administration until end of surgery
|
Chest pain, nausea, vomiting
|
From oxytocin administration until end of surgery
|
|
Patient satisfaction questionnaire
Časové okno: 2 hours after surgery
|
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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Tiffany E Angelo, DO, FASA, Stony Brook University Hospital Department of Anesthesiology
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- IRB2026-00322
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .