Effects of Analgesic Techniques on Duration of Labor for Induction Patients (NCT01982851) | Clinical Trial Compass
TerminatedNot Applicable
Effects of Analgesic Techniques on Duration of Labor for Induction Patients
Stopped: low qualified candidate enrollment
United States134 participantsStarted 2010-07
Plain-language summary
The purpose of this study is to determine if there is a difference in the duration of the first stage of labor in nulliparous women scheduled for an induction of labor, with whom analgesia is maintained with a combined spinal epidural (CSE) technique versus an epidural de novo technique. The investigators hypothesize that the duration of the first stage of labor will be no different in nulliparous patients who receive either intrathecal fentanyl or intrathecal fentanyl and bupivacaine, as part of a CSE technique. However, the duration of the first stage of labor will be shorter in parturients who receive intrathecal analgesia (as part of a CSE technique) compared to those who receive an epidural de novo technique with fentanyl and bupivacaine.
Who can participate
Age range
18 Years – 45 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:
* Nulliparous
* American Society of Anesthesia Physical Status (ASA) 2 females
* \> 18 years old
* term (\>37 weeks gestation)
* singleton
* vertex pregnancies
* scheduled induction of labor
Exclusion Criteria:
* Non-vertex presentation
* Spontaneous labor or spontaneous rupture of membranes
* contraindication to opioid or neuraxial analgesia
* contraindication to combine spinal-epidural technique (e.g. unfavorable airway exam)
* cervical dilation \> 4.0cm
* administration of systemic hydromorphine within 4 hours of epidural request
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
Duration of first stage of labor
Timeframe: Onset of contractions or rupture of membrances to cervical dilation of 10cm