Patient Compliance With Long-Acting Reversible Contraception Administration

NCT03305081 | Terminated Results DMC

• 1 other identifier: IRBNet ID 628424-1
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This a randomized control trial to identify if patients who desire LARC are more likely to have success receiving the desired form of contraception if it is placed a) during the postpartum hospital stay, either in the immediate or early postpartum period, versus b) during the interval postpartum period as previously done.

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

• Number of Women With Placement of LARC

  The outcome will be measured by the number of participants with LARC placement. The total number of women who expressed a desire to have postpartum contraception placed and randomized to the appropriate arm will be assessed.

  6 months

Secondary Outcomes (1)

• Patient Satisfaction With Method of LARC Using LARC Survey

  6 Weeks, 12 weeks postpartum, 6 months postpartum

Study Arms (2)

Immediate or early placement

EXPERIMENTAL

Immediate or early placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant (within 48 hours) postpartum

Device: Levonorgestrel IUD, copper IUD, etonorgestrel implant

Interval placement

ACTIVE COMPARATOR

Interval (4-6 weeks) postpartum placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant

Device: Levonorgestrel IUD, copper IUD, etonorgestrel implant

Interventions

Levonorgestrel IUD, copper IUD, etonorgestrel implant DEVICE

Long-acting reversible contraception

Immediate or early placement; Interval placement

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant, desires LARC postpartum

You may not qualify if:

• Medical contraindication to desired LARC, vaginal delivery complicated by fourth degree perineal laceration, history of pelvic inflammatory disease, uterine infection

Sponsors & Collaborators

• Tulane University School of Medicine: lead

Study Sites (1)

Tulane Department of Obstetrics and Gynecology

New Orleans, Louisiana, 70018, United States

Location

Related Publications (9)

• Brito MB, Ferriani RA, Quintana SM, Yazlle ME, Silva de Sa MF, Vieira CS. Safety of the etonogestrel-releasing implant during the immediate postpartum period: a pilot study. Contraception. 2009 Dec;80(6):519-26. doi: 10.1016/j.contraception.2009.05.124. Epub 2009 Jul 10.

  PMID: 19913145 RESULT

• Celen S, Sucak A, Yildiz Y, Danisman N. Immediate postplacental insertion of an intrauterine contraceptive device during cesarean section. Contraception. 2011 Sep;84(3):240-3. doi: 10.1016/j.contraception.2011.01.006. Epub 2011 Feb 21.

  PMID: 21843687 RESULT

• Chen BA, Reeves MF, Hayes JL, Hohmann HL, Perriera LK, Creinin MD. Postplacental or delayed insertion of the levonorgestrel intrauterine device after vaginal delivery: a randomized controlled trial. Obstet Gynecol. 2010 Nov;116(5):1079-87. doi: 10.1097/AOG.0b013e3181f73fac.

  PMID: 20966692 RESULT

• Dahlke JD, Terpstra ER, Ramseyer AM, Busch JM, Rieg T, Magann EF. Postpartum insertion of levonorgestrel--intrauterine system at three time periods: a prospective randomized pilot study. Contraception. 2011 Sep;84(3):244-8. doi: 10.1016/j.contraception.2011.01.007. Epub 2011 Feb 24.

  PMID: 21843688 RESULT

• 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 RESULT

• Guazzelli CA, de Queiroz FT, Barbieri M, Torloni MR, de Araujo FF. Etonogestrel implant in postpartum adolescents: bleeding pattern, efficacy and discontinuation rate. Contraception. 2010 Sep;82(3):256-9. doi: 10.1016/j.contraception.2010.02.010. Epub 2010 Mar 29.

  PMID: 20705154 RESULT

• Levi E, Cantillo E, Ades V, Banks E, Murthy A. Immediate postplacental IUD insertion at cesarean delivery: a prospective cohort study. Contraception. 2012 Aug;86(2):102-5. doi: 10.1016/j.contraception.2011.11.019. Epub 2012 Jan 20.

  PMID: 22264666 RESULT

• Shukla M, Qureshi S; Chandrawati. Post-placental intrauterine device insertion--a five year experience at a tertiary care centre in north India. Indian J Med Res. 2012 Sep;136(3):432-5.

  PMID: 23041736 RESULT

• Stuart GS, Bryant AG, O'Neill E, Doherty IA. Feasibility of postpartum placement of the levonorgestrel intrauterine system more than 6 h after vaginal birth. Contraception. 2012 Apr;85(4):359-62. doi: 10.1016/j.contraception.2011.08.005. Epub 2011 Sep 28.

  PMID: 22067759 RESULT

Results Point of Contact

• Title: Resident of OB/GYN
• Organization: TulaneU

sjunya@tulane.edu

858-499-2702

Study Officials

• Sara Junya, MD

  Tulane University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: October 9, 2017
• Study Start: October 22, 2014
• Primary Completion: December 21, 2015
• Study Completion: May 31, 2016
• Last Updated: January 22, 2021
• Results First Posted: January 22, 2021

Record last verified: 2021-01

Locations

US (1)