NCT02657148

Brief Summary

The investigators have designed a single site, Phase IV open label, prospective observational clinical trial to compare the effect of immediate postpartum Nexplanon placement (IPP) versus standard postpartum contraceptive care (control) on consistent contraceptive use and rapid repeat pregnancy at 12 months postpartum in 200 opioid dependent (OD) women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 15, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

2.3 years

First QC Date

September 21, 2015

Last Update Submit

August 30, 2018

Conditions

Opiate AddictionPregnancyContraceptive BehaviorSexual Behavior

Outcome Measures

Primary Outcomes (1)

  • Consistent contraception

    Number of participants who use highly effective contraception (all hormonal methods or the copper T380 IUD) for ≥ 80% of the first postpartum year

    12 months postpartum

Secondary Outcomes (6)

  • Rapid, repeat pregnancy

    12 months postpartum

  • Breastfeeding initiation

    12 months postpartum

  • Postpartum depression

    12 months postpartum

  • Infant weight gain

    12 months

  • Infant development

    12 months

  • +1 more secondary outcomes

Study Arms (2)

Immediate postpartum Nexplanon

Participants who choose to enroll in the immediate postpartum Nexplanon arm will have a etonogestrel contraceptive implant (68 mg) (Nexplanon) placed in the immediate postpartum period (2-4 days following delivery), prior to hospital discharge.

Drug: Nexplanon (etonogestrel contraceptive implant)

Control

Participants who choose to enroll in the control arm will receive standard postpartum contraceptive care: condoms, Depo Provera (DMPA) or progestin-only pills initiated at any time after delivery, Nexplanon insertion at \> 4 weeks after delivery, combined hormonal contraception (e. g. pills, patch, ring) initiated at any time \> 4 weeks after delivery or levonorgestrel-intrauterine system or copper IUD insertion any time \> 6 weeks after delivery.

Drug: Standard postpartum contraceptive care

Interventions

Nexplanon (etonogestrel contraceptive implant)DRUG

Nexplanon is a single, radiopaque, rod-shaped implant, containing 68 mg etonogestrel indicated for postpartum contraceptive use by women to prevent pregnancy. Nexplanon is designed to be effective for 3 years.

Also known as: Nexplanon
Immediate postpartum Nexplanon
Standard postpartum contraceptive careDRUG

Condoms, Depo Provera (DMPA) or progestin-only pills initiated at any time after delivery, Nexplanon insertion at \> 4 weeks after delivery, combined hormonal contraception (e. g. pills, patch, ring) initiated at any time \> 4 weeks after delivery or levonorgestrel-intrauterine system or copper IUD insertion any time \> 6 weeks after delivery.

Also known as: Postpartum contraception
Control

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women, 18 years or older, who meet DSM-V criteria for opioid use disorder confirmed by diagnostic coding in the patient's medical record and/or urinary toxicology screen (UDS) and who plan to deliver at the study site hospital, Magee-Womens Hospital of UPMC (MWH-UPMC).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (16)

  • Patrick SW, Schumacher RE, Benneyworth BD, Krans EE, McAllister JM, Davis MM. Neonatal abstinence syndrome and associated health care expenditures: United States, 2000-2009. JAMA. 2012 May 9;307(18):1934-40. doi: 10.1001/jama.2012.3951. Epub 2012 Apr 30.

    PMID: 22546608BACKGROUND

  • Heil SH, Jones HE, Arria A, Kaltenbach K, Coyle M, Fischer G, Stine S, Selby P, Martin PR. Unintended pregnancy in opioid-abusing women. J Subst Abuse Treat. 2011 Mar;40(2):199-202. doi: 10.1016/j.jsat.2010.08.011. Epub 2010 Oct 30.

    PMID: 21036512BACKGROUND

  • Rabin RF, Jennings JM, Campbell JC, Bair-Merritt MH. Intimate partner violence screening tools: a systematic review. Am J Prev Med. 2009 May;36(5):439-445.e4. doi: 10.1016/j.amepre.2009.01.024.

    PMID: 19362697BACKGROUND

  • van Bussel JC, Spitz B, Demyttenaere K. Reliability and validity of the Dutch version of the maternal antenatal attachment scale. Arch Womens Ment Health. 2010 Jun;13(3):267-77. doi: 10.1007/s00737-009-0127-9. Epub 2009 Oct 27.

    PMID: 19859787BACKGROUND

  • 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: 19913145BACKGROUND

  • Tocce K, Sheeder J, Python J, Teal SB. Long acting reversible contraception in postpartum adolescents: early initiation of etonogestrel implant is superior to IUDs in the outpatient setting. J Pediatr Adolesc Gynecol. 2012 Feb;25(1):59-63. doi: 10.1016/j.jpag.2011.09.003. Epub 2011 Nov 3.

    PMID: 22051792BACKGROUND

  • 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: 20464722BACKGROUND

  • Tocce KM, Sheeder JL, Teal SB. Rapid repeat pregnancy in adolescents: do immediate postpartum contraceptive implants make a difference? Am J Obstet Gynecol. 2012 Jun;206(6):481.e1-7. doi: 10.1016/j.ajog.2012.04.015. Epub 2012 Apr 16.

    PMID: 22631865BACKGROUND

  • Sinha C, Guthrie KA, Lindow SW. A survey of postnatal contraception in opiate-using women. J Fam Plann Reprod Health Care. 2007 Jan;33(1):31-4. doi: 10.1783/147118907779399738.

    PMID: 17389093BACKGROUND

  • Gipson JD, Koenig MA, Hindin MJ. The effects of unintended pregnancy on infant, child, and parental health: a review of the literature. Stud Fam Plann. 2008 Mar;39(1):18-38. doi: 10.1111/j.1728-4465.2008.00148.x.

    PMID: 18540521BACKGROUND

  • Baldwin MK, Edelman AB. The effect of long-acting reversible contraception on rapid repeat pregnancy in adolescents: a review. J Adolesc Health. 2013 Apr;52(4 Suppl):S47-53. doi: 10.1016/j.jadohealth.2012.10.278.

    PMID: 23535057BACKGROUND

  • Morrison CL, Ruben SM, Beeching NJ. Female sexual health problems in a drug dependency unit. Int J STD AIDS. 1995 May-Jun;6(3):201-3. doi: 10.1177/095646249500600311.

    PMID: 7647124BACKGROUND

  • Armstrong KA, Kenen R, Samost L. Barriers to family planning services among patients in drug treatment programs. Fam Plann Perspect. 1991 Nov-Dec;23(6):264-6, 270-1.

    PMID: 1786807BACKGROUND

  • Ralph N, Spigner C. Contraceptive practices among female heroin addicts. Am J Public Health. 1986 Aug;76(8):1016-7. doi: 10.2105/ajph.76.8.1016.

    PMID: 3728758BACKGROUND

  • Armstrong KA, Kennedy MG, Kline A, Tunstall C. Reproductive health needs: comparing women at high, drug-related risk of HIV with a national sample. J Am Med Womens Assoc (1972). 1999 Spring;54(2):65-70, 78.

    PMID: 10319594BACKGROUND

  • Black KI, Stephens C, Haber PS, Lintzeris N. Unplanned pregnancy and contraceptive use in women attending drug treatment services. Aust N Z J Obstet Gynaecol. 2012 Apr;52(2):146-50. doi: 10.1111/j.1479-828X.2012.01413.x. Epub 2012 Feb 15.

    PMID: 22335489BACKGROUND

MeSH Terms

Conditions

Opioid-Related DisordersContraception BehaviorSexual Behavior

Interventions

etonogestrel

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersReproductive BehaviorBehavior

Study Officials

  • Elizabeth E Krans, MD, MSc

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Obstetrics, Gynecology & Reproductive Sciences

Study Record Dates

First Submitted

September 21, 2015

First Posted

January 15, 2016

Study Start

May 1, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

August 31, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)