Current partner codePEPTIDESDE
NCT07688512·Phase 4·INTERVENTIONAL

Oxytocin Bolus Versus Infusion in High-Risk Patients Undergoing Elective Cesarean Section (INBOX-HR)

Status

Not yet recruiting

Phase

Phase 4

Enrollment

180

Locations

0

Results

Not posted

Publications

7

Study summary

What the protocol is testing.

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: 1. 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? 2. Does Oxytocin bolus cause less maternal side effects than Oxytocin infusion? 3. 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: 1. Be randomized to receive either Oxytocin bolus or Oxytocin infusion during their cesarean section but after the baby is born. 2. Be asked a question about their experience 2 hours after the surgery. 3. Allow the research team to collect information about how they are doing from their hospital medical records.

Full detailed 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. 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.

Interventions

Treatment arms and agents.

DRUG

Oxytocin Bolus or Oxytocin Infusion

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.

Timeline

From registration to results.

  1. First posted

    Jul 7, 2026

  2. Study start

    Aug 2026

  3. Primary completion

    Aug 2028

  4. Study completion

    Feb 2029

  5. Results posted

    Not reported

  6. Registry updated

    Jul 7, 2026

Outcomes

What the study measures.

Primary outcomes

Time to uterine tone

Time frame · 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.

Secondary outcomes

Estimated intraoperative blood loss

Time frame · From the start to end of surgery

Changes in heart rate (beats per minute)

Time frame · During uterine cord clamp and every 2 minutes thereafter until 10 minutes

Changes in blood pressure (mmHg)

Time frame · During uterine cord clamp and every 2 minutes thereafter until 10 minutes.

Total dose of phenylephrine administered intraoperatively

Time frame · From the start to end of surgery

Need for additional uterotonic agents

Time frame · From oxytocin administration until end of surgery

Such as Methergine, Hemabate, and Cytotec

0-10 Uterine tone score

Time frame · 2 minutes after uterine cord clamping until 10 minutes.

Uterine tone score will be assessed at 2 mins and then every minute thereafter.

Maternal side effects

Time frame · From oxytocin administration until end of surgery

Chest pain, nausea, vomiting

Patient satisfaction questionnaire

Time frame · 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).

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
45 Years
Sex
FEMALE
Healthy volunteers
No

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

Study locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

Publications

Results and literature.

PMID 37576820Wang 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.PMID 20142652Oyelese Y, Ananth CV. Postpartum hemorrhage: epidemiology, risk factors, and causes. Clin Obstet Gynecol. 2010 Mar;53(1):147-56. doi: 10.1097/GRF.0b013e3181cc406d.PMID 33487681Joseph 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 6093538Fuchs 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 29151071Terblanche 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 24667448Balki 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 25103301Say 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.

Primary links

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