Investigating the Effect of Pulsatile Administration of Oxytocin on the Desensitization of Human Myometrium In-vitro
1 other identifier
interventional
18
1 country
1
Brief Summary
Postpartum hemorrhage (PPH) is a leading cause of maternal morbidity and mortality worldwide and is caused most commonly by poor uterine muscle (myometrium) tone after delivery. The first line agent used in the prevention and treatment of PPH is oxytocin. Women who require augmentation of labor with intravenous oxytocin because of inadequate labor progression have been shown to be at increased risk of PPH. Typically, for augmentation of labor, oxytocin is used as a continuous infusion, with no consensus on the initial dose, its increments or maximal limit. High concentration continuous oxytocin infusions are not without theirs risks, which include hyperstimulation, fetal distress, as well as uterine rupture. Studies have shown the clinical benefits of pulsatile oxytocin delivery for labor induction and augmentation with regards to requirement of less total oxytocin, similar uterine contractility and similar rates of caesarean delivery when used for labor induction and augmentation. However, the rate of PPH as a primary outcome measure has not been investigated. Therefore we currently do not know the effect of pulsatile oxytocin delivery on the rate of PPH. The investigators hypothesize that the effect of myometrial desensitization following pulsatile oxytocin exposure would be lower when compared to continuous oxytocin exposure. These results will help in establishing whether myometrial contractility and sensitivity to oxytocin can be better preserved by delivery of pulsatile oxytocin, rather than continuous oxytocin for labor induction and augmentation, and thereby result in less PPH.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 9, 2015
CompletedFirst Posted
Study publicly available on registry
January 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedSeptember 4, 2015
September 1, 2015
5 months
January 9, 2015
September 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Motility Index
Motility index (MI) takes into account both the amplitude and frequency of the myometrial contraction. It is a calculated outcome, based on the formula: frequency/(10 x amplitude). The analysis is undertaken by attaching myometrial strips between an isometric force transducer and the base of an organ bath chamber.
8 hours
Secondary Outcomes (3)
Amplitude of contraction
8 hours
Frequency of contraction
8 hours
Integrated area under response curve (AUC)
8 hours
Study Arms (3)
Control (no oxytocin) pretreatment
NO INTERVENTIONPhysiological saline solution (PSS). Every 15-minutes, the PSS will be flushed and fresh PSS will be added.
Continuous oxytocin (desensitizing) pretreatment
ACTIVE COMPARATORContinuous oxytocin 10-5M. This desensitizing treatment is based on previous experiments in our laboratory demonstrating this phenomenon (reference 25 of Internal Review). The desensitizing pretreatment mimics the clinical setting of labor augmentation. Every 15-minutes, the 10-5M oxytocin will be flushed and fresh 10-5M oxytocin will be added.
Pulsatile oxytocin pretreatment
ACTIVE COMPARATOR15-minutes of 10-5M oxytocin, followed by PSS for 15-minutes, followed by 10-5M oxytocin, followed by 15-minutes PSS, and so-on, for a total duration of two-hours,
Interventions
Oxytocin, 100 micromolar solution
Eligibility Criteria
You may qualify if:
- Patients who give written consent to participate in this study
- Patients with gestational age 37-41 weeks
- Non-laboring patients, not exposed to exogenous oxytocin
- Patients requiring primary Cesarean delivery or first repeat Cesarean delivery
You may not qualify if:
- Patients who refuse to give written informed consent
- Patients who require general anesthesia
- Patients who had previous uterine surgery or more than one previous Cesarean delivery
- Patients with any condition predisposing to uterine atony and postpartum hemorrhage, such as abnormal placentation, multiple gestation, preeclampsia, macrosomia, polyhydramnios, uterine fibroids, bleeding diathesis, chorioamnionitis, or a previous history of postpartum bleeding
- Emergency Cesarean section in labor
- Patients on medications that could affect myometrial contractility, such as nifedipine, labetolol or magnesium sulphate.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mount Sinai Hospital
Toronto, Ontario, M5G1X5, Canada
Related Publications (1)
Talati C, Carvalho JCA, Luca A, Balki M. The Effect of Intermittent Oxytocin Pretreatment on Oxytocin-Induced Contractility of Human Myometrium In Vitro. Anesth Analg. 2019 Apr;128(4):671-678. doi: 10.1213/ANE.0000000000002834.
PMID: 29401080DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mrinalini Balki, MD
MOUNT SINAI HOSPITAL
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2015
First Posted
January 14, 2015
Study Start
January 1, 2015
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
September 4, 2015
Record last verified: 2015-09