title: A Dedicated Postpartum Intrauterine Device Inserter: Pilot Experience and Proof of Concept.
abstract: OBJECTIVE
  To assess the feasibility, acceptability, and safety of a dedicated postpartum intrauterine device (PPIUD) inserter specifically designed for the post-delivery setting. Primary objectives of fundal placement and expulsion rates were assessed. Secondary objectives were participant satisfaction and IUD retention.
  
  
  METHODS
  In this pilot proof of concept, we enrolled 80 women who presented for PPIUD insertion at 2 government hospitals in Delhi and Lucknow, India, between March and July 2015. PPIUD insertion was completed with the dedicated inserter in all cases, by trained providers with no prior experience in PPIUD insertion, followed immediately by ultrasound to assess location and fundal placement of the IUD. Follow-up took place at 6 to 8 weeks post-insertion, and ultrasound was used to assess IUD location. Providers and participants also completed satisfaction surveys.
  
  
  RESULTS
  High fundal placement (≤10 mm from uterine fundus) was achieved with the dedicated PPIUD inserter in 82% of cases (n = 65). There were no perforations or infections among the participants and no other complications associated with use of the dedicated inserter. The mean distance between the IUD and the endometrial verge immediately post-insertion was 5.8 mm (range, 0-31; N = 80); this distance at follow-up was also 5.8 mm (range, 0-25; n = 50). Complete expulsion was observed in 6 cases (7.5%), and asymptomatic partial expulsion in 8 cases (10%). Providers reported the majority (93%, n = 74) of insertions to be easy. The majority (74%, n = 59) of participants reported the same level of pain before and after insertion.
  
  
  CONCLUSIONS
  This dedicated PPIUD inserter performed as intended and was found to be safe, with high acceptability among the participants and providers. Further study and use of the dedicated inserter may reveal reduced risk of infection among PPIUD users as well as increased convenience compared with standard PPIUD insertion techniques, and could improve acceptability of postpartum IUD provision among providers. The success of this study has led to the initiation of a formal randomized controlled trial in India to further investigate the acceptability of the dedicated inserter.
authors.affiliation: Population Services International-India, New Delhi, India.
authors.forename: Sharad
authors.initials: S
authors.lastname: Singh
authors.affiliation: King George Medical University, Queen Mary Hospital, Department of Obstetrics and Gynecology, Lucknow, Uttar Pradesh, India.
authors.forename: Vinita
authors.initials: V
authors.lastname: Das
authors.affiliation: King George Medical University, Queen Mary Hospital, Department of Obstetrics and Gynecology, Lucknow, Uttar Pradesh, India.
authors.forename: Anjoo
authors.initials: A
authors.lastname: Agarwal
authors.affiliation: Safdarjung Hospital, Department of Obstetrics and Gynecology, New Delhi, India.
authors.forename: Rupali
authors.initials: R
authors.lastname: Dewan
authors.affiliation: Safdarjung Hospital, Department of Obstetrics and Gynecology, New Delhi, India.
authors.forename: Pratima
authors.initials: P
authors.lastname: Mittal
authors.affiliation: Population Services International-India, New Delhi, India.
authors.forename: Renita
authors.initials: R
authors.lastname: Bhamrah
authors.affiliation: Stanford University School of Medicine, Department of Obstetrics and Gynecology, Stanford, CA, USA.
authors.forename: Klaira
authors.initials: K
authors.lastname: Lerma
authors.affiliation: Stanford University School of Medicine, Department of Obstetrics and Gynecology, Stanford, CA, USA Population Services International, Washington, DC, USA.
authors.forename: Paul D
authors.initials: PD
authors.lastname: Blumenthal
mesh_terms: D000293:Adolescent; D000328:Adult; D003267:Contraception / Q000295:instrumentation / Q000379:methods*; D004868:Equipment Failure; D004864:Equipment and Supplies / Q000009:adverse effects / Q000592:standards*; D005193:Family Planning Services / Q000379:methods*; D005260:Female; D006282:Health Personnel; D006761:Hospitals; D006801:Humans; D007194:India; D007239:Infections / Q000209:etiology; D007434:Intrauterine Devices; D010146:Pain; D017060:Patient Satisfaction; D010865:Pilot Projects; D049590:Postpartum Period; D014599:Uterus; D055815:Young Adult