N/A
N=135
Postplacental Intrauterine Device Insertion: A Mixed Methods Assessment of Women's Experience
Contraception
Bottom Line
View on ClinicalTrials.gov: NCT02312726 ↗Enrolled (actual)
135
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: Assessment of Women's Experiences With Ring Forceps Postplacental IUD Placement Through Semi-structured Interviews — 12; 7; 0; 2 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Postplacental IUD insertion (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of New Mexico
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment of Women's Experiences With Ring Forceps Postplacental IUD Placement Through Semi-structured Interviews |
12; 7; 0; 2; 0; 0 | — |
| SECONDARY Pain Score: Visual Analog Scale (VAS) |
10.6; 35.3; 10.9; 41.4; 5.4; 28.6 | — |
| SECONDARY Pain Score: Verbal Rating Scale (VRS) |
34; 15; 32; 16; 12; 6 | — |
Summary
The primary objective of this mixed methods pilot study is to understand women's experiences with postplacental intrauterine device (IUD) insertion through postpartum semi-structured interviews. For secondary objectives, the investigators will collect visual analog scale (VAS) and verbal rating score (VRS) data on women's pain experienced just before and immediately after IUD insertion. The investigators will perform postpartum interviews in each group until we reach thematic saturation. The investigators will recruit at least 60 women (30 each in the epidural and no epidural group) from the University of New Mexico Hospital (UNMH) affiliated antenatal clinics to conduct our quantitative data analysis.
Eligibility Criteria
Inclusion Criteria
- English-speaking or Spanish-speaking only (SSO) women
- Women who express a desire to have an IUD inserted immediately following anticipated vaginal delivery.
Exclusion Criteria
- Unanticipated cesarean delivery
- Chorioamnionitis
- Significant postpartum hemorrhage (estimated blood loss requiring intervention beyond standard therapy and not resolved within approximately 10 minutes)
- Third or fourth degree obstetric vaginal laceration
- Manual extraction of the placenta
- Untreated gonorrhea, chlamydia and/or trichomoniasis
- Known or suspected distorted uterine cavity
- Current use of controlled substances for chronic pain management
- Current substance abuse/ addiction.
Data sourced from ClinicalTrials.gov (NCT02312726). 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.