title: Effects of the copper intrauterine device versus injectable progestin contraception on pregnancy rates and method discontinuation among women attending termination of pregnancy services in South Africa: a pragmatic randomized controlled trial.
abstract: BACKGROUND
  The copper intrauterine device (IUD) is under-utilised in South Africa, where injectable progestin contraception (IPC) dominates contraception usage. There is a lack of robust comparative data on these contraceptive options to inform policy, programs, clinical counseling, and women's choices.
  
  
  METHODS
  Within the context of a South African program to increase women's access to the IUD, we conducted a pragmatic, open-label, parallel-arm, randomised controlled trial of the IUD versus IPC at two South African hospitals. The target sample size was 7,000 women and the randomisation ratio was 1:1. The random sequence was computer-generated and group allocation was concealed in sealed, opaque, consecutively-numbered envelopes. Counselled, consenting women attending termination of pregnancy services were randomly assigned to IUD or IPC immediately post-termination. Condoms were promoted for the prevention of sexually-transmitted infections. The primary outcome was pregnancy; secondary outcomes were discontinuation, side-effects, and HIV acquisition and disease progression. Pregnancy and discontinuation outcomes are reported here.
  
  
  RESULTS
  The trial closed early with 2,493 participants randomised (IUD = 1,247, IPC = 1,246), due to international concerns regarding a possible association between IPC and HIV acquisition. Median follow-up was 20 months; 982 and 1000 participants were followed up in the IUD and IPC groups, respectively. Baseline group characteristics were comparable. Pregnancy occurred significantly less frequently among women allocated to the IUD than IPC: 56/971 (5.8%) versus 83/992 (8.4%), respectively; risk ratio (RR) 0.69, 95% confidence interval (CI) 0.50 to 0.96; P = 0.025. There were more protocol violations in the IUD group; however, discontinuation rates were similar between IUD and IPC groups (141/855 [16.5%] and 143/974 [14.7%], respectively). Women in the IUD group were more likely to discontinue contraceptive use due to abdominal pain or backache and non-specific symptoms, and those in the IPC group due to oligo- or amenorhoea and lack of sexual activity.
  
  
  CONCLUSIONS
  The IUD was significantly more effective in preventing pregnancy than IPC. Efforts to expand contraception options and improve access to the IUD in settings where it is under-utilised are worthwhile. This trial shows that randomising long-acting, reversible contraceptives is feasible.
  
  
  BACKGROUND
  Pan African Clinical Trials Registry number PACTR201409000880157 (04-09-2014).
authors.affiliation: Effective Care Research Unit, Eastern Cape Department of Health/Universities of the Witwatersrand, Walter Sisulu and Fort Hare, Mthatha, Eastern Cape, South Africa.
authors.forename: G Justus
authors.initials: GJ
authors.lastname: Hofmeyr
authors.affiliation: Effective Care Research Unit, Eastern Cape Department of Health/Universities of the Witwatersrand, Walter Sisulu and Fort Hare, Mthatha, Eastern Cape, South Africa.
authors.forename: Mandisa
authors.initials: M
authors.lastname: Singata-Madliki
authors.affiliation: Effective Care Research Unit, Eastern Cape Department of Health/Universities of the Witwatersrand, Walter Sisulu and Fort Hare, Mthatha, Eastern Cape, South Africa. tess@lawrie.com.|Royal United Hospital, Bath, UK. tess@lawrie.com.
authors.forename: Theresa A
authors.initials: TA
authors.lastname: Lawrie
authors.affiliation: Institute for Clinical Effectiveness and Health Policy (IECS), Buenos Aires, Argentina.
authors.forename: Eduardo
authors.initials: E
authors.lastname: Bergel
authors.affiliation: Reproductive Health and Research, World Health Organization, Geneva, Switzerland.|International Centre for Reproductive Health, Ghent University, Ghent, Belgium.
authors.forename: Marleen
authors.initials: M
authors.lastname: Temmerman
mesh_terms: D015746:Abdominal Pain / Q000139:chemically induced / Q000209:etiology; D000029:Abortion, Legal; D000293:Adolescent; D000328:Adult; D001416:Back Pain / Q000139:chemically induced / Q000209:etiology; D003268:Contraception Behavior / Q000208:ethnology; D003271:Contraceptive Agents, Female / Q000008:administration & dosage / Q000009:adverse effects*; D004343:Drug Implants / Q000009:adverse effects; D057239:Early Termination of Clinical Trials; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007435:Intrauterine Devices, Copper / Q000009:adverse effects*; D059012:Lost to Follow-Up; D017258:Medroxyprogesterone Acetate / Q000008:administration & dosage / Q000009:adverse effects; D009640:Norethindrone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D011184:Postoperative Period; D011247:Pregnancy; D018873:Pregnancy Rate / Q000208:ethnology; D011372:Progestins / Q000008:administration & dosage / Q000009:adverse effects*; D013019:South Africa / Q000453:epidemiology; D055815:Young Adult
chemical_list: D003271:Contraceptive Agents, Female; D004343:Drug Implants; D011372:Progestins; D017258:Medroxyprogesterone Acetate; C024319:norethindrone enanthate; D009640:Norethindrone
keywords: DMPA; IUD; Random