Bleeding Patterns and Complications After Postpartum IUD Placement: a Pilot Study
This study is ongoing, but not recruiting participants.
Sponsor:
Baystate Medical Center
Information provided by (Responsible Party):
Katharine White, Baystate Medical Center
ClinicalTrials.gov Identifier:
NCT01309919
First received: March 4, 2011
Last updated: April 16, 2012
Last verified: April 2012
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Purpose
The purpose of the study is to determine the feasibility of placing the levonorgestrel-releasing intrauterine system (LNG - IUS, Mirena®) post-delivery. The investigators will gain information about complications at the time of placement; the investigators will also examine the expulsion rate, side effects, bleeding patterns and subject satisfaction at various time periods after insertion.
| Condition | Intervention |
|---|---|
|
Postpartum Period |
Device: Mirena intrauterine system Other: Bleeding diary |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Bleeding Patterns and Complications After Postpartum Intrauterine Device (IUD) Placement: a Pilot Study |
Resource links provided by NLM:
Further study details as provided by Baystate Medical Center:
Primary Outcome Measures:
- feasibility of placing the levonorgestrel-releasing intrauterine system (LNG - IUS, Mirena®) post-delivery [ Time Frame: within 48 hours of delivery ] [ Designated as safety issue: No ]Assessment of the logistical issues surrounding postpartum IUD placement (availability of the IUD, securing equipment and ultrasound, ability to place the device)
Secondary Outcome Measures:
- expulsion rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]examine the incidence of spontaneous IUD expulsion in the six months after insertion
- subject satisfaction [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]To examine subject satisfaction with both the IUD and the IUD insertion process, to be assessed at 3 and 6 months post-insertion
- bleeding patterns [ Time Frame: 3 months ] [ Designated as safety issue: No ]to compare postpartum bleeding patterns of women who receive a postpartum Mirena with those of women who do not receive a Mirena.
| Estimated Enrollment: | 150 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: IUD Arm
Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)
|
Device: Mirena intrauterine system
Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery)
Other Name: Mirena intrauterine system
|
|
No Intervention: Diary-Only Arm
Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all
|
Other: Bleeding diary
Subjects will keep a bleeding diary for three months
Other Name: bleeding diary (three-month calendar)
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- age 18 years or older
- speak either English or Spanish
- desire to use an IUD as their postpartum contraception (IUD arm)
- do NOT desire an IUD as their contraception (Diary Only arm)
- plan to deliver at Baystate Medical Center.
Exclusion Criteria:
- history of sexually transmitted infection during the three months prior to enrollment
- desiring of another pregnancy within six months of giving birth
- routine contraindications to IUD:
- cavity-distorting uterine fibroids or uterine anomalies
- known or suspected uterine or cervical neoplasia
- acute liver disease or liver tumor
- history of breast cancer
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01309919
Locations
| United States, Massachusetts | |
| Baystate Medical Center | |
| Springfield, Massachusetts, United States, 01199 | |
Sponsors and Collaborators
Baystate Medical Center
Investigators
| Principal Investigator: | Katharine O White, MD, MPH | Baystate Medical Center |
More Information
No publications provided
| Responsible Party: | Katharine White, Chief, Division of General OB/GYN, Baystate Medical Center |
| ClinicalTrials.gov Identifier: | NCT01309919 History of Changes |
| Other Study ID Numbers: | BH10-190 |
| Study First Received: | March 4, 2011 |
| Last Updated: | April 16, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Baystate Medical Center:
|
intrauterine device Mirena levonorgestrel intrauterine system postpartum contraception |
Additional relevant MeSH terms:
|
Hemorrhage Pathologic Processes Levonorgestrel Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents |
Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Contraceptives, Oral, Synthetic Contraceptives, Oral |
ClinicalTrials.gov processed this record on May 21, 2013