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临床试验/NCT02312726
NCT02312726已完成不适用

Postplacental Intrauterine Device Insertion: A Mixed Methods Assessment of Women's Experience

University of New Mexico1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
135
试验地点
1
主要终点
Assessment of Women's Experiences With Ring Forceps Postplacental IUD Placement Through Semi-structured Interviews

研究概览

简要总结

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.

详细描述

Postplacental IUD insertion following vaginal or cesarean delivery is as effective in preventing pregnancy as interval insertion, and it is utilized more often in other countries such as China, Mexico and Egypt compared with the US (Celen, Moroy et al. 2004; Eroglu, Akkuzu et al. 2006; Kapp and Curtis 2009; Grimes, Lopez et al. 2010). In addition, current evidence supports the safety and superior cost effectiveness of IUD use (Trussell, Lalla et al. 2009; ACOG 2011). Postplacental IUD insertion is practiced routinely in US hospitals with active family planning faculty (including University of New Mexico Hospital), and has become standard of care for postpartum contraception options counseling in these institutions. Despite ample evidence supporting the safety and effectiveness of postplacental IUD insertion, the practice is uncommon among US providers and many women remain unaware of this option. Reasons for underutilization in the US may include lack of reimbursement, sufficient provider knowledge and training, and patient awareness.

Postplacental IUD insertion is also an attractive method for provision of postpartum contraception for several reasons: women are motivated to initiate contraception, they are not pregnant, and access to medical care is readily available.

Pain is a subjectively complex and universal experience which encompasses more experiential aspects than objective measurements of physical pain can capture. We know that interval IUD placement is painful, and that anxiety and fear of pain can be a barrier to IUD uptake, particularly among adolescent women (Allen, Bartz et al. 2009). Pain and low satisfaction with the IUD insertion procedure may limit patients' endorsement of the method to other women. There is insufficient research examining the patient's subjective experience with postplacental IUD placement. In addition, there is limited data about the physical pain level associated with postplacental IUD insertion.

Several studies have examined the efficacy of interventions to reduce pain for interval IUD insertion for nulliparous and multiparous women (Hubacher, Reyes et al. 2006; Edelman, Schaefer et al. 2011; Maguire, Davis et al. 2012; Swenson, Turok et al. 2012). Procedural aspects and clinical circumstances of postplacental IUD insertion differ substantially from those associated with interval insertion, preventing extrapolation of findings from studies of interval IUD insertion to postplacental insertion.

Specific aims:

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • English-speaking or Spanish-speaking only (SSO) women
  • Women who express a desire to have an IUD inserted immediately following anticipated vaginal delivery.

排除标准

  • 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.

结局指标

主要结局

Assessment of Women's Experiences With Ring Forceps Postplacental IUD Placement Through Semi-structured Interviews

时间窗: Within 24-48 hours after vaginal delivery, prior to hospital discharge

A semi-structured interview guide(available in both English and Spanish) which was developed in consultation with an expert in qualitative methodology at the UNM Clinical \& Translational Science Center (CTSC), and UNMH family planning experts, will be administered to all participants. The interview will incorporate the following domains of women's perceptions of the postplacental IUD insertion experience: decisional influence, experience during the procedure, decisional regret, prior knowledge/ awareness of the method and postpartum contraception in general. The interview will conclude with an overall patient satisfaction score measured on a five-point Likert scale: 1 = very dissatisfied, 2 = somewhat dissatisfied, 3 = neutral, 4 = somewhat satisfied, 5 = very satisfied.

次要结局

  • Pain Score: Verbal Rating Scale (VRS)(Immediately prior to and within 5 minutes after IUD insertion following vaginal delivery. Women who undergo a postpartum interview will be asked to perform a recal VRS pain assessment)
  • Pain Score: Visual Analog Scale (VAS)(Immediately prior to and within 5 minutes after IUD insertion following vaginal delivery; women who undergo a postpartum interview will be asked to perform a recall VAS pain assessment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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