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:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT06049160
Eligibility Criteria:
Inclusion Criteria:
1. Gestational age ( 37 to 41 weeks).
2. Singleton healthy fetus.
3. Scheduled for elective lower segment caesarean delivery under spinal anaesthesia.
4. Body mass index of (25-30 Kg/m2).
5. Normal coagulation profile.
6. Normal amniotic fluid volume assessed by amniotic fluid index.
Exclusion Criteria:
1. Maternal comorbidity: Hypertension; diabetes; heart, kidney, or liver disorders.
2. Contraindication to use of misoprostol like known allergy to misoprostol or asthmatic patients.
3. Women who had undergone any previous uterine surgery such as myomectomy because it is considered upper uterine segment operation with more destruction in myometrium but caesarean section is a lower segment uterine operation with minimal destruction in myometrium.
4. Women at higher risk of intraoperative blood loss or PPH, such as those with hemoglobin levels less than 9 g/dl, history of PPH, or uterine fibroids.
5. Antepartum hemorrhage ( placenta previa and placental abruption).
6. Women who will undergo caesarean section because of failure of induction of labor.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT06049160
Study Brief:
Protocol Section:
NCT06049160