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 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 1:14 AM
NCT ID:
NCT04887493
Eligibility Criteria:
Inclusion Criteria:
* Age 18 or more years
* Primigravida
* Singleton pregnancy
* Gestation at 41 or more weeks of pregnancy
* Estimated fetal weight of \<4000 gram
* In cephalic presentation
* Bishop score \< 6 (unfavorable cervix)
* Reassuring fetal heart rate tracing
Exclusion Criteria:
* Age \<18 years
* Multiple pregnancy (twin, triplet and higher order pregnancies)
* Gestation \<41 weeks of pregnancy
* Fetal macrosomia (Estimated fetal weight \>4000 gram)
* Cephalo-pelvic disproportion
* Malpresentation (breech, oblique, transverse)
* Bishop score \>6 (favorable cervix)
* Presence of labor or uterine contractions
* Non-reassuring fetal heart rate tracing
* Pregnant women with known allergy to misoprostol,
* Previous Caesarean delivery or other uterine surgery
* Previous uterine rupture
* Placenta previa
* Chorioamnionitis
* Prelabour rupture of membrane (PROM)
* Antepartum hemorrhage (per vaginal bleeding)
* Contraindication to vaginal birth
* Medical disorders in pregnancy
* Active genital herpes infection
* Invasive cervical carcinoma
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04887493
Study Brief:
Protocol Section:
NCT04887493