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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.
Reprod Health 2016; 13:42RH

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.

TRIAL REGISTRATION

Pan African Clinical Trials Registry number PACTR201409000880157 (04-09-2014).

Authors+Show Affiliations

Effective Care Research Unit, Eastern Cape Department of Health/Universities of the Witwatersrand, Walter Sisulu and Fort Hare, Mthatha, Eastern Cape, South Africa.Effective Care Research Unit, Eastern Cape Department of Health/Universities of the Witwatersrand, Walter Sisulu and Fort Hare, Mthatha, Eastern Cape, South Africa.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.Institute for Clinical Effectiveness and Health Policy (IECS), Buenos Aires, Argentina.Reproductive Health and Research, World Health Organization, Geneva, Switzerland. International Centre for Reproductive Health, Ghent University, Ghent, Belgium.

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

27091008

Citation

Hofmeyr, G Justus, et al. "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." Reproductive Health, vol. 13, 2016, p. 42.
Hofmeyr GJ, Singata-Madliki M, Lawrie TA, et al. 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. Reprod Health. 2016;13:42.
Hofmeyr, G. J., Singata-Madliki, M., Lawrie, T. A., Bergel, E., & Temmerman, M. (2016). 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. Reproductive Health, 13, p. 42. doi:10.1186/s12978-016-0153-9.
Hofmeyr GJ, et al. 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. Reprod Health. 2016 Apr 18;13:42. PubMed PMID: 27091008.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Hofmeyr,G Justus, AU - Singata-Madliki,Mandisa, AU - Lawrie,Theresa A, AU - Bergel,Eduardo, AU - Temmerman,Marleen, Y1 - 2016/04/18/ PY - 2016/02/12/received PY - 2016/03/23/accepted PY - 2016/4/20/entrez PY - 2016/4/20/pubmed PY - 2016/10/14/medline KW - DMPA KW - IUD KW - Random SP - 42 EP - 42 JF - Reproductive health JO - Reprod Health VL - 13 N2 - 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. TRIAL REGISTRATION: Pan African Clinical Trials Registry number PACTR201409000880157 (04-09-2014). SN - 1742-4755 UR - https://www.unboundmedicine.com/medline/citation/27091008/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_ L2 - https://reproductive-health-journal.biomedcentral.com/articles/10.1186/s12978-016-0153-9 DB - PRIME DP - Unbound Medicine ER -