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:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
NCT ID:
NCT02411916
Eligibility Criteria:
Inclusion criteria (A patient will be considered for inclusion in the study if she meets all of the following criteria):
* She has a term (≥37 completed weeks) live singleton gestation in cephalic presentation and has been admitted to the Labor and Delivery Unit
* She is in the latent phase of labor or has been admitted for induction of labor or at prenatal clinic visit
* She has had fewer than four prior vaginal deliveries.
* She reports no allergy to misoprostol.
The following factors or conditions will exclude a patient from consideration as a subject:
* The fetus has a known major fetal malformation or chromosome abnormality
* The gestation is multiple.
* There is a breech or other malpresentation
* The patient reports involvement in another clinical trial currently or previously in this pregnancy.
* The patient is expected to have a cesarean delivery.
* The patient had a prior cesarean delivery.
* There has been an intrauterine fetal death.
* There is polyhydramnios (amniotic fluid index \>22 cm).
* Presence of acute or chronic renal disease
* Presence of preeclampsia
Exclusion criteria (Of subjects who enter the study, the development of certain conditions will exclude them post hoc from receiving misoprostol under the protocol, and from the data analysis. These conditions include):
* Unanticipated cesarean delivery.
* Performance of episiotomy (third and fourth degree extensions will be excluded).
* Vaginal or cervical laceration, or perineal laceration of more than second degree in depth.
* Severe postpartum hemorrhage requiring intervention immediately after delivery.
* Uterine rupture
* Placental abruption.
* Patient withdrawal of consent.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02411916
Study Brief:
Protocol Section:
NCT02411916