N/A
N=150
Bleeding Patterns and Complications After Postpartum IUD Placement: a Pilot Study
Postpartum Period
Bottom Line
View on ClinicalTrials.gov: NCT01309919 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcome: Primary: Bleeding Patterns — 15; 18; 13; 7 days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- IUD (Device); Diary (Other)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Baystate Medical Center
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bleeding Patterns |
15; 18; 13; 7; 5.5; 8 | — |
| SECONDARY Expulsions |
3 | — |
| SECONDARY Satisfaction |
82; 11 | — |
| SECONDARY Insertion Time |
5.5 | — |
Summary
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01309919). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.