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 @ 6:26 PM
Ignite Modification Date:
2025-12-24 @ 6:26 PM
NCT ID:
NCT06010368
Eligibility Criteria:
nclusion Criteria:
* Women booked for a primary elective cesarean section, not in active labor
* Aged between 20-40 years.
* BMI 18.5-29.9 kg/ m2 pre-pregnancy weight
* Term pregnancies (Early term: between 37 weeks, 0 days and 38 weeks, 6 days. Full term: between 39 weeks, 0 days and 40 weeks, 6 days. Late term: between 41 weeks, 0 days and 41 weeks, 6 days).
* Singleton pregnancies.
* Indication of elective cesarean section (Malpresentation, Malposition, Cephalopelvic disproportion, active herpes)
* Fetal macrosomia (Macrosomia is defined as birth-weight over 4,000 g irrespective of gestational age)
* Certain congenital fetal malformation and skeletal disorders (Several congenital anomalies are controversial indications for cesarean delivery; these include fetal neural tube defects (to avoid sac rupture), particularly defects that are larger than 5-6 cm in diameter as anterior cystic hygroma vascular sacrococcygeal teratoma, giant omphalocele and hydrocephalus with an enlarged biparietal diameter, and some skeletal dysplasia such as type III osteogenesis imperfecta. (Hamrick et al., 2008)
Exclusion Criteria:
* Placenta previa.
* Maternal hypertension and Preeclampsia.
* Diabetes mellitus.
* Severe medical disorder (renal or hepatic).
* Multiple Fibroid uterus.
* Multiple pregnancies.
* Polyhydramnios.
* Previous uterine surgery as myomectomy.
* Contraindication to spinal anesthesia.
* Blood coagulopathy and bleeding disorder.
* Marked maternal anemia (Preoperative hemoglobin \<9 gm/dl).
* Contraindications to TXA or oxytocin therapy (e.g. allergy)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
40 Years
Study:
NCT06010368
Study Brief:
Protocol Section:
NCT06010368