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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07440069
Eligibility Criteria:
Inclusion Criteria:
* Nulliparous pregnant women
* Age between 15 and 45 years
* Singleton pregnancy, term (37-41 weeks gestation)
* Cephalic presentation
* Active labor defined as cervical dilation ≥4 cm with regular contractions
* Signed informed consent
Exclusion Criteria:
* Multiple gestation or high-risk pregnancy (preeclampsia, gestational diabetes, etc.)
* Known allergy or contraindication to tramadol or paracetamol
* Recent use (less than 6 hours) of any analgesic medication
* Previous cesarean section or other uterine surgery
* Active infection or fever at admission
* Inability to provide informed consent due to mental or communication conditions
* Non-cephalic presentation
* Rupture of membranes \>18 hours without labor
* Participation in another clinical trial within the last 3 months
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
15 Years
Maximum Age:
45 Years
Study:
NCT07440069
Study Brief:
Protocol Section:
NCT07440069