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

NCT02312726 | Completed Results

• 1 other identifier: UNM HSC 13-440
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Contraception

Keywords

mixed methods; visual analog scale; verbal rating score; pain assessment; patient satisfaction; contraceptive devices; postpartum

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Secondary Outcomes (2)

• 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

• 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

Other Outcomes (1)

• Provider Ease-of-insertion

  Within 5 minutes following postpartum IUD insertion

Study Arms (2)

Epidural group

Participants who elect to have an epidural anesthesia during labor, delivery and postplacental IUD insertion

Procedure: Postplacental IUD insertion

Non Epidural group

Participants who elect not to have epidural anesthesia during labor, delivery and postplacental IUD insertion

Procedure: Postplacental IUD insertion

Interventions

Postplacental IUD insertion PROCEDURE

Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery.

Also known as: Immediate postpartum IUD insertion

Epidural group; Non Epidural group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will recruit women from the University of New Mexico Hospital (UNMH) affiliated antenatal clinics. We will also recruit women from the UNMH obstetric units, provided the women are not in labor. Women will be approached about participation in the study if, after routine antenatal contraceptive counseling conducted in the third trimester, they report that they would like to undergo postplacental IUD insertion. We will use convenience sampling.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of New Mexico: lead
• Society of Family Planning: collaborator

Study Sites (1)

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87131, United States

Location

Related Publications (12)

• ACOG Practice Bulletin No. 121: Long-acting reversible contraception: Implants and intrauterine devices. Obstet Gynecol. 2011 Jul;118(1):184-196. doi: 10.1097/AOG.0b013e318227f05e. No abstract available.

  PMID: 21691183 BACKGROUND

• Allen RH, Bartz D, Grimes DA, Hubacher D, O'Brien P. Interventions for pain with intrauterine device insertion. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD007373. doi: 10.1002/14651858.CD007373.pub2.

  PMID: 19588429 BACKGROUND

• Celen S, Moroy P, Sucak A, Aktulay A, Danisman N. Clinical outcomes of early postplacental insertion of intrauterine contraceptive devices. Contraception. 2004 Apr;69(4):279-82. doi: 10.1016/j.contraception.2003.12.004.

  PMID: 15033401 BACKGROUND

• Edelman AB, Schaefer E, Olson A, Van Houten L, Bednarek P, Leclair C, Jensen JT. Effects of prophylactic misoprostol administration prior to intrauterine device insertion in nulliparous women. Contraception. 2011 Sep;84(3):234-9. doi: 10.1016/j.contraception.2011.01.016. Epub 2011 Mar 3.

  PMID: 21843686 BACKGROUND

• Eroglu K, Akkuzu G, Vural G, Dilbaz B, Akin A, Taskin L, Haberal A. Comparison of efficacy and complications of IUD insertion in immediate postplacental/early postpartum period with interval period: 1 year follow-up. Contraception. 2006 Nov;74(5):376-81. doi: 10.1016/j.contraception.2006.07.003. Epub 2006 Sep 15.

  PMID: 17046378 BACKGROUND

• Grimes DA, Lopez LM, Schulz KF, Van Vliet HA, Stanwood NL. Immediate post-partum insertion of intrauterine devices. Cochrane Database Syst Rev. 2010 May 12;(5):CD003036. doi: 10.1002/14651858.CD003036.pub2.

  PMID: 20464722 BACKGROUND

• Hubacher D, Reyes V, Lillo S, Zepeda A, Chen PL, Croxatto H. Pain from copper intrauterine device insertion: randomized trial of prophylactic ibuprofen. Am J Obstet Gynecol. 2006 Nov;195(5):1272-7. doi: 10.1016/j.ajog.2006.08.022.

  PMID: 17074548 BACKGROUND

• Kapp N, Curtis KM. Intrauterine device insertion during the postpartum period: a systematic review. Contraception. 2009 Oct;80(4):327-36. doi: 10.1016/j.contraception.2009.03.024. Epub 2009 Aug 29.

  PMID: 19751855 BACKGROUND

• Maguire K, Davis A, Rosario Tejeda L, Westhoff C. Intracervical lidocaine gel for intrauterine device insertion: a randomized controlled trial. Contraception. 2012 Sep;86(3):214-9. doi: 10.1016/j.contraception.2012.01.005. Epub 2012 Feb 9.

  PMID: 22325115 BACKGROUND

• Speroff L, Mishell DR Jr. The postpartum visit: it's time for a change in order to optimally initiate contraception. Contraception. 2008 Aug;78(2):90-8. doi: 10.1016/j.contraception.2008.04.005. Epub 2008 Jun 12. No abstract available.

  PMID: 18672108 BACKGROUND

• Swenson C, Turok DK, Ward K, Jacobson JC, Dermish A. Self-administered misoprostol or placebo before intrauterine device insertion in nulliparous women: a randomized controlled trial. Obstet Gynecol. 2012 Aug;120(2 Pt 1):341-7. doi: 10.1097/AOG.0b013e31825d9ec9.

  PMID: 22825094 BACKGROUND

• Trussell J, Lalla AM, Doan QV, Reyes E, Pinto L, Gricar J. Cost effectiveness of contraceptives in the United States. Contraception. 2009 Jan;79(1):5-14. doi: 10.1016/j.contraception.2008.08.003. Epub 2008 Sep 25.

  PMID: 19041435 BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Michel Paves, Research Specialist
• Organization: University of New Mexico - Family Planning Research Division

mdaliva@salud.unm.edu

505-272-9703

Study Officials

• Rameet H Singh, MD, MPH

  UNM OB GYN Division of Family Planning

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2014
• First Posted: December 9, 2014
• Study Start: November 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 4, 2016
• Results First Posted: April 4, 2016

Record last verified: 2016-03

Locations

US (1)