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 @ 4:11 AM
Ignite Modification Date:
2025-12-25 @ 4:11 AM
NCT ID:
NCT00147420
Eligibility Criteria:
Inclusion and Exclusion Criteria
Adult, pregnant women who satisfy all the following criteria may be enrolled in the study. Pregnant women:
* who are delivering during the study period at one of the three hospitals
* who are 18 years of age or older at the time of delivery
* who are 28 weeks or more pregnant
* who are likely to have a normal vaginal delivery
* with singleton intrauterine pregnancy with vertex presentation either in early labor or in anticipation of induction of labor, and
* whose fetus is alive (has a heart rate \>100bpm) at the time of screening
* who are able to give informed consent.
Any of the following criteria will exclude a woman from study participation:
* pre-term labor (\<28 weeks)
* previous or planned cesarean delivery
* current multiple gestations
* active hemorrhaging
* severe anemia (Hgh \<7)
* hypertension (persistent BP\>140/90 or greater OR hypertension requiring treatment) \[this criteria was omitted mid-study\]
* maternal history of bleeding disorders
* known allergies to any medications (severe chronic allergic conditions)
* body temperature greater than 38ºC
* asthma (asthma requiring treatment)
* mental disability
* unable to focus on consent process due to imminent delivery
To be eligible for participation as a care provider, the participant must satisfy the following criteria:
* obstetrical care provider to pregnant woman in the study
* at least 18 years of age
* must be a physician or nurse midwife
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00147420
Study Brief:
Protocol Section:
NCT00147420