Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2025-12-24 @ 2:13 PM
NCT ID:
NCT07278895
Eligibility Criteria:
Inclusion Criteria:
1. Term pregnant women (≥37 weeks of gestation).
2. Requesting neuraxial labor analgesia.
3. Age between 18 and 45 years.
4. ASA physical status I-II.
5. Cervical dilation ≥ 4 cm at the time of enrollment.
6. Cervical effacement ≥ 50-60%.
7. Baseline pain score of VAS ≥ 3.
8. Ability to provide informed consent.
Exclusion Criteria:
1. Hypertensive disorders of pregnancy (gestational hypertension, preeclampsia, eclampsia).
2. Placental abnormalities (placenta previa, placental abruption, etc.).
3. Contraindications to neuraxial anesthesia (coagulopathy, infection at puncture site, severe hypovolemia).
4. Known allergy or hypersensitivity to local anesthetics or opioids used in the study.
5. Morbid obesity (Body Mass Index ≥ 40 kg/m²).
6. Opioid dependence or chronic opioid use.
7. Accidental dural puncture with the epidural needle prior to randomization.
8. Multiple gestation or non-cephalic presentation (if clinically relevant to your protocol).
9. Fetal distress at the time of enrollment.
10. Patient refusal to participate.
11. Any condition deemed by the investigator to pose increased risk or interfere with study outcomes.
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Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT07278895
Study Brief:
Protocol Section:
NCT07278895