Continuous Birth Support by Student Midwives and Labor Pain and Birth Satisfaction (NCT07563374) | Clinical Trial Compass
CompletedNot Applicable
Continuous Birth Support by Student Midwives and Labor Pain and Birth Satisfaction
Turkey (Türkiye)90 participantsStarted 2024-12-03
Plain-language summary
This randomized controlled study aimed to evaluate the effect of continuous birth support provided by senior student midwives on labor outcomes, birth perception, and birth satisfaction. Pregnant women admitted for spontaneous vaginal birth were randomly assigned to either a continuous birth support group or a routine care control group. The intervention consisted of continuous non-pharmacological support provided by trained student midwives under supervision throughout labor. Primary outcomes included perceived birth pain and birth satisfaction, while secondary outcomes included birth perception and obstetric interventions.
Who can participate
Age range
18 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:
* Pregnant women aged 18 years or older
* Singleton pregnancy
* Gestational age ≥ 37 completed weeks
* Low-risk pregnancy
* Planned vaginal birth
* Admitted to the labor ward in the latent or early active phase of labor
* No pharmacological analgesia before the first pain assessment
* Ability to communicate and provide written informed consent
Exclusion Criteria:
* High-risk pregnancy requiring continuous medical or obstetric intervention
* Planned cesarean section
* Multiple pregnancy
* Known fetal anomaly
* Use of pharmacological analgesia (e.g., epidural anesthesia, systemic opioids) before baseline pain assessment
* Obstetric complications requiring emergency intervention at admission (e.g., fetal distress, placental abruption, cord prolapse)
* Inability to cooperate with breathing exercises
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
Change in labor pain intensity from baseline to active labor.
Timeframe: Baseline and during active labor, up to 24 hours
2
Birth satisfaction measured by the Birth Satisfaction Scale-Revised