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 @ 4:33 AM
Ignite Modification Date:
2025-12-25 @ 4:33 AM
NCT ID:
NCT03603418
Eligibility Criteria:
Inclusion Criteria:
1. Primipara.
2. Gestational age (39-41) weeks according to Naegele's rule and a first-trimester ultrasound evaluation.
3. Vertex presentation.
4. Singleton fetus.
5. Intact fetal membranes.
6. No contraindication for vaginal delivery.
7. Cervix with a poor Bishop score (4-6).
8. Reactive CTG.
9. Average amount of liquor.
Exclusion Criteria:
1. Indication for cesarean section e.g. CPD, Placenta previa, IUGR, Non vertex presentation and previous cesarean section.
2. Maternal medical disorders as diabetes mellitus and severe pre-eclampsia.
3. Active phase of labor (cervical dilatation of 4 cm plus 3 forceful contractions over a ten minute span).
4. Preterm labor and premature rupture of membranes.
5. Multiparous women.
6. Significant vaginal bleeding. Placenta previa, probable placental abruption.
7. Fetal macrosomia\>4.5 kg estimated by u/s.
8. Multiple pregnancy.
9. Fetal Distress and Non-reactive CTG.
10. Oligohydramnios.
11. IUGR.
Healthy Volunteers:
True
Sex:
FEMALE
Study:
NCT03603418
Study Brief:
Protocol Section:
NCT03603418