A Pilot Study of Early Postpartum Intrauterine Contraception (ImmPPIUD)
This study has been completed.
Sponsor:
University of North Carolina, Chapel Hill
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00997932
First received: September 28, 2009
Last updated: December 13, 2012
Last verified: July 2011
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Purpose
This is a prospective clinical trial of ultrasound guided intrauterine contraception insertion 10 minutes - 48 hours after vaginal delivery of single infant. A six month follow-up will entail three follow-up visits; 4-6 weeks, 3 months, and 6 months.
The objective of this study is to measure intrauterine device (IUD) expulsion and the feasibility of conducting a future clinical trial to evaluate placement of the levonorgestrel-releasing intrauterine contraceptive 10 minutes - 48 hours postpartum.
| Condition | Intervention | Phase |
|---|---|---|
|
Unplanned Pregnancy |
Device: Mirena Intrauterine Contraceptive System |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Pilot Study of Early Postpartum Intrauterine Contraception |
Resource links provided by NLM:
Further study details as provided by University of North Carolina, Chapel Hill:
Primary Outcome Measures:
- IUD expulsion [ Time Frame: From time of insertion to final study date which is 6 months after IUD insertion. ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Feasibility of enrollment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 40 |
| Study Start Date: | June 2009 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Device: Mirena Intrauterine Contraceptive System
- Intrauterine device
- Mirena
- Intrauterine contraception
Postpartum placement of the IUD
Other Names:
Eligibility| Ages Eligible for Study: | 21 Years to 35 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00997932
Locations
| United States, North Carolina | |
| University of North Carolina at Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27514 | |
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
| Principal Investigator: | Gretchen Stuart, MD | University of North Carolina, Chapel Hill |
More Information
No publications provided
| Responsible Party: | Gretchen S. Stuart, MD, MPHTM Assistant Professor of Obstetrics and Gynecology, University of North Carolina at Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT00997932 History of Changes |
| Other Study ID Numbers: | SFP3-14 |
| Study First Received: | September 28, 2009 |
| Last Updated: | December 13, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by University of North Carolina, Chapel Hill:
|
levonorgestrel releasing intrauterine device levonorgestrel releasing intrauterine contraception unintended pregnancy prevention postpartum contraception |
Additional relevant MeSH terms:
|
Contraceptive Agents Levonorgestrel Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions |
Therapeutic Uses Contraceptive Agents, Female Contraceptives, Oral, Synthetic Contraceptives, Oral |
ClinicalTrials.gov processed this record on June 18, 2013