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 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT06472232
Eligibility Criteria:
Inclusion Criteria:
* Primigravid women with full-term pregnancies scheduled for labor analgesia
* Determination of labor onset to cervical dilatation ≤ 5cm;
* Visual analogue scale (VAS) pain score during contractions \>50 mm (0 mm = no pain at all, 100 mm = most intense pain);
* Age ≥20 years;
* American Society of Anesthesiologists (ASA) classification II
* Body mass index (BMI) between 18.5 and 30 kg/m2
* Height \>155 cm
* Signed informed consent.
Exclusion Criteria:
* Twin or multiple pregnancies
* Hypertension
* Severe cardiopulmonary and hepatic or renal disease
* Severe pregnancy comorbidities such as preeclampsia, eclampsia, HELLP syndrome, placenta praevia, placental abruption, etc.
* Cephalopelvic disproportion
* History of allergy to local anesthesia
* Spinal deformity
* Contraindications to intrathecal anesthesia
* Refusal to participate in the stud
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
20 Years
Study:
NCT06472232
Study Brief:
Protocol Section:
NCT06472232