Internal Versus External Tocodynamometry and Labor Outcome (NCT02941393) | Clinical Trial Compass
CompletedNot Applicable
Internal Versus External Tocodynamometry and Labor Outcome
Finland1,500 participantsStarted 2012-11
Plain-language summary
In this study, parturients will be randomized to either internal or external tocodynamometry contractions' follow up. Investigators recruit primiparous, those who try to have vaginal birth after cesarean section and multiparous, who need oxytocin during labor. Primary endpoint is the number of operative labors in each group. Secondary endpoints are the duration of labor, the use of oxytocin and the condition of the newborn.
Who can participate
Age range
18 Years – 50 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:
* gestational age ≥ 37 weeks
* singleton pregnancy
* a fetus in cephalic position
* normal cardiotocograph in the time of randomization
* cervical ripening \< 7 cm
* either 1) primipara, 2) multipara, who needs oxytocin during first stage of labor or 3) parturients with previous cesarean section
Exclusion Criteria:
* parturient with hepatitis or HIV or other significant viral infection
* Acute infections (fever over 37,5, or C-reactive protein over 20) in the time of randomization
* Estimated fetal weight over 4,5 kg
* Suspected fetal abnormality
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
Number of cesarean sections
Timeframe: through study completion, an average of 6 years
2
Number of operative vaginal deliveries
Timeframe: through study completion, an average of 6 years