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 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT00997932
Eligibility Criteria:
Inclusion Criteria:
* Currently pregnant with a single gestation of at least 27 completed weeks estimated gestational age, with no complications of pregnancy including, but not limited to, preeclampsia, non-gestational diabetes, anemia.
* Desires to use intrauterine contraception (IUD) after delivery
* Anticipates having a vaginal delivery
* No intention to leave the area 7 months after enrollment
* Able to consent to participate in the study in English
* Has no known uterine anomalies
* Has no allergies to any components of the intrauterine contraception
Exclusion Criteria:
* Prior cesarean delivery
* Having been treated for pelvic inflammatory disease within 3 months prior to the start of the pregnancy
* Allergic to betadine
* Allergy to lidocaine
* Medical or personal conditions which in the judgment of study staff contradict participation in the study
* Any contraindications to use of the levonorgestrel-releasing intrauterine contraceptive system which includes: known or suspected breast carcinoma, acute liver disease or liver tumor, history of ectopic pregnancy, cervical cancer or carcinoma in situ
* After enrollment, and after delivery of the infant but before IUD insertion subjects will be excluded by checking with the attending obstetric physician and/or obstetric medical chart for the following:
* Endometritis or chorioamnionitis during the intrapartum period
* Membranes ruptured for greater than 24 hours prior to delivery
* Fever greater than or equal to 38C
* The need to use additional medications other than pitocin and/or misoprostol to control postpartum bleeding
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
45 Years
Study:
NCT00997932
Study Brief:
Protocol Section:
NCT00997932