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:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2025-12-24 @ 2:08 PM
NCT ID:
NCT01161095
Eligibility Criteria:
Inclusion Criteria:
* All women \>37 weeks gestation who desire LNG-IUS for postpartum contraception who do not have a contraindication as described below will be offered participation in our study.
Exclusion Criteria:
Contraindications to the LNG-IUS include:
* Pregnancy or suspicion of pregnancy
* Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity
* Postpartum endometritis within the past 3 months
* Known or suspected uterine or cervical neoplasia or unresolved, abnormal pap smear
* untreated acute cervicitis or vaginitis including bacterial vaginosis or other lower genital tract infections
* acute liver disease or liver tumor
* hypersensitivity to any component of the product
* known or suspected carcinoma of the breast
Any of these conditions would exclude the patient from receiving these forms of contraception in our study.
In addition the following intrapartum findings, the following would exclude the patient:
* Delivery \<37 weeks
* Intrapartum chorioamnionitis (defined as maternal fever \>100.4 and two of the following conditions: Maternal leukocytosis (greater than 15,000 cells/cubic millimeter), Maternal tachycardia (greater than 100 beats/minute), Fetal tachycardia (greater than 160 beats/minute), Uterine tenderness, Foul odor of the amniotic fluid
* Postpartum Hemorrhage (defined as \>500cc EBL for spontaneous vaginal delivery or \>1000cc for cesarean delivery)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01161095
Study Brief:
Protocol Section:
NCT01161095