Dosing Strategies for Automated Mandatory Intermittent Boluses Technique for Epidural Labour Anal… (NCT01205360) | Clinical Trial Compass
WithdrawnNot Applicable
Dosing Strategies for Automated Mandatory Intermittent Boluses Technique for Epidural Labour Analgesia
0Started 2010-08
Plain-language summary
The purpose of this study is to determine how manipulation of the programmed intermittent time interval and volume influences total drug use, quality of analgesia, and patient satisfaction during maintenance of labor analgesia.
Who can participate
Age range
18 Years – 35 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Full term women in spontaneous labor.
* Gestation greater than or equal to 37 weeks.
* Primigravida.
* Age group between 18 Years to 45 Years.
* ASA grade I or II
* Not having any complicated pregnancy
* Not having any systemic disorders.
Exclusion Criteria:
* Not willing for Epidural analgesia.
* Unwilling to get enrolled in this study.
* Systemic disorder like diabetes mellitus, hypertension and heart disease, spine deformity, blood coagulation disorder, bad obstetric history and foetal abnormity.
* Multiple-pregnancy or abnormal presentation.
* Complicated pregnancy like pregnancy induced hypertension, placenta previa, abruptio placenta.
* Cervical dilatation less than 2 or greater than 5 at time of initiation of neuraxial analgesia.
* Chronic analgesic medications
* Systemic opioid labor analgesia prior to the initiation of neuraxial labor analgesia.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total epidural bupivacaine dose
Timeframe: 48 hours
Trial details
NCT IDNCT01205360
SponsorPravara Institute of Medical Sciences University