Continuous Versus Intermittent Oxytocin Infusion for Induction of Labor
A Comparison Between Continuous Versus Intermittent Oxytocin Infusion for Induction of Labor
1 other identifier
interventional
153
1 country
1
Brief Summary
The study will compare 2 treatment modalities. One group will receive the routine protocol of intermittent pitocin induction for 6 hours and the second group will receive continous pitocin infusion for 16 hours. The primary aim is to observe which protocol leads to the fastest delivery and evaluate the time in each group from induction to delivery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2019
Typical duration 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
First Submitted
Initial submission to the registry
July 10, 2019
CompletedFirst Posted
Study publicly available on registry
July 12, 2019
CompletedStudy Start
First participant enrolled
November 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedSeptember 13, 2023
September 1, 2023
2.7 years
July 10, 2019
September 11, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Delivery within 24 hours
The percentage of women delivering within 24 hours.
from admission up to 24 hours postpartum
Secondary Outcomes (4)
latent phase of labor.
from admission up to 24 hours postpartum
active phase of labor.
from admission up to 24 hours postpartum
caesarian deliveries
from admission up to 24 hours postpartum
instrumental deliveries
from admission up to 24 hours postpartum
Study Arms (2)
Intermittent treatment
ACTIVE COMPARATORInfusion of oxytocin for 6 hours at a time until patient delivers.
Continous treatment
ACTIVE COMPARATORInfusion of oxytocin continuously from patient admission for 16 hours.
Interventions
Eligibility Criteria
You may qualify if:
- Women with a singleton pregnancy that are admitted for induction or augmentation of labor.
- Women at gestational age 370/7 or more.
- Vertex presentation.
You may not qualify if:
- Age under 18 or over 45.
- High order gestation.
- Women with contraindication for vaginal delivery.
- Active labor.
- Women with a uterine scar.
- Multiparity(\> 5 deliveries).
- Documented fetal anomalies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rambam health care campus
Haifa, Israel
Related Publications (1)
Bachar G, Abu-Rass H, Farago N, Justman N, Buchnik G, Chen YS, David CB, Goldfarb N, Khatib N, Ginsberg Y, Zipori Y, Weiner Z, Vitner D. Continuous vs intermittent induction of labor with oxytocin in nulliparous patients: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 Dec;5(12):101176. doi: 10.1016/j.ajogmf.2023.101176. Epub 2023 Oct 7.
PMID: 37813304DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roy Lauterbach, MD
Principal Investigator
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 10, 2019
First Posted
July 12, 2019
Study Start
November 1, 2019
Primary Completion
June 30, 2022
Study Completion
June 30, 2022
Last Updated
September 13, 2023
Record last verified: 2023-09