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 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07474350
Eligibility Criteria:
Inclusion Criteria:
* Primigravidae / nulliparae.
* Singleton term pregnancy with no evidence of maternal or fetal distress.
* Women with fetus in cephalic presentation.
* Age: 18- 35 years.
* Women with no contra-indications to vaginal delivery.
* Cervical dilatations of 4- 9cm when in labour
* Spontaneous or induced labour.
* Patients on epidural analgesia
Exclusion Criteria:
* Multiple gestations.
* Women with abnormal fetal presentation.
* Absolute indications for caesarean section.
* Antepartum hemorrhage.
* Evidence of maternal or fetal distress.
* Fibroid in pregnancy.
* Grand multiparous patients.
* Previous uterine scar/ surgery or ruptures.
* Medical disorders of pregnancy like pre-eclempsia, Eclempsia, Dm etc.
* If any other antispasmodics agent had been used within the last 48 hours.
* Preterm/ term premature rupture of membranes.
* History of cervical injury/ surgery.
* Hypersensitivity to valethamate bromide and/or hyoscine butyl bromide
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT07474350
Study Brief:
Protocol Section:
NCT07474350