Clinical trial NCT02657148: Immediate Postpartum Nexplanon Placement in Opioid Dependent Women
Official title: A Prospective Observational Clinical Trial to Compare the Effect of Immediate Postpartum Nexplanon Placement Versus Standard Postpartum Contraceptive Care on Consistent Contraceptive Use and Rapid Repeat Pregnancy in Opioid Dependent Women.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opiate Addiction
Pregnancy
Contraceptive Behavior
Sexual Behavior
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2016-01-15
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_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).

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.

Detailed description: Background: Opioid dependence in pregnancy has increased dramatically in the last decade. Over 86% of pregnancies conceived by OD women are unintended, compared to 31-43% of pregnancies in the general population. In evaluations of contraceptive use among sexually active women in opioid treatment programs, 40-75% of sexually active OD women report no contraceptive use. Even among women using contraception, 45-55% report using only condoms without more effective, hormonal contraception. Pregnancy and the postpartum period are unique opportunities to provide contraceptive education and services. Long-acting reversible contraception (LARC) has been shown to more effectively prevent rapid repeat, unintended pregnancies compared to other postpartum contraceptive options and does not incur the risk of venous thromboembolism associated with estrogen-containing methods (i.e. pills, ring, patch). No studies have evaluated the impact of immediate postpartum etonogestrel implant (Nexplanon) placement on reproductive health outcomes in OD women, a population at significant risk for rapid repeat, unintended pregnancy. In contrast to an intrauterine device (IUD), Nexplanon is safe to insert regardless of labor and delivery circumstances, does not incur an increased risk of postpartum expulsion and is long-acting, which makes it the ideal contraceptive for the immediate postpartum period.

Study site:This single site study will be conducted at Magee-Womens Hospital (MWH) of the University of Pittsburgh Medical Center.

Study Procedures: Recruitment - participants will be recruited during the third trimester of pregnancy (≥ 28 weeks gestation) during prenatal care visits.

Immediate postpartum Nexplanon placement (IPP) - participants who choose to enroll in the IPP Nexplanon arm will have Nexplanon placed in the immediate postpartum period (2-4 days following delivery), prior to hospital discharge.

Standard postpartum contraceptive care (control) - participants who choose to enroll in the control arm will receive a contraceptive method of their choice according to standard clinical protocols. Standard clinical protocols include 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.

Study Duration: 12 months

Eligibility criteria: Inclusion Criteria: 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).

Exclusion Criteria: Women who have contraindications to etonogestrel use, intrauterine fetal demise or stillbirth, and/or who do not plan to deliver at MWH-UPMC.

Primary outcomes:
measure: Consistent contraception
timeFrame: 12 months postpartum
Secondary outcomes:
measure: Rapid, repeat pregnancy
timeFrame: 12 months postpartum
measure: Breastfeeding initiation
timeFrame: 12 months postpartum
measure: Postpartum depression
timeFrame: 12 months postpartum
measure: Infant weight gain
timeFrame: 12 months
measure: Infant development
timeFrame: 12 months
measure: High-risk sexual behavior
timeFrame: 12 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee-Womens Hospital of UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Elizabeth E Krans, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.