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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.

Hofmeyr GJ, Singata-Madliki M, Lawrie TA, Bergel E, Temmerman M - Reprod Health (2016)

Bottom Line: Pregnancy and discontinuation outcomes are reported here.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.The IUD was significantly more effective in preventing pregnancy than IPC.

View Article: PubMed Central - PubMed

Affiliation: Effective Care Research Unit, Eastern Cape Department of Health/Universities of the Witwatersrand, Walter Sisulu and Fort Hare, Mthatha, Eastern Cape, South Africa.

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).

No MeSH data available.


Related in: MedlinePlus

CONSORT diagram showing the flow of participants
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Fig1: CONSORT diagram showing the flow of participants

Mentions: At closure, 2,493 of the target sample had accrued (36 %), with 1,247 and 1,246 women randomised to the IUD and IPC groups, respectively. An additional 19 randomisation envelopes could not be linked to participants (see CONSORT Fig. 1). Baseline data for the IUD and IPC groups were well matched (Table 1). Data on the primary outcome were available for 1,963 participants (78.7 %). The median time to final interview was 20 months (interquartile range 15 to 28). In the IUD group, 56 out of 971 women (5.8 %) became pregnant during follow-up compared with 83 out of 992 women (8.4 %) in the IPC group (risk ratio (RR) 0.69, 95 % confidence interval (CI) 0.50 to 0.96; P = 0.025). There were no statistically significant differences between groups for the type of pregnancy outcome (Table 2).Fig. 1


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.

Hofmeyr GJ, Singata-Madliki M, Lawrie TA, Bergel E, Temmerman M - Reprod Health (2016)

CONSORT diagram showing the flow of participants
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4835872&req=5

Fig1: CONSORT diagram showing the flow of participants
Mentions: At closure, 2,493 of the target sample had accrued (36 %), with 1,247 and 1,246 women randomised to the IUD and IPC groups, respectively. An additional 19 randomisation envelopes could not be linked to participants (see CONSORT Fig. 1). Baseline data for the IUD and IPC groups were well matched (Table 1). Data on the primary outcome were available for 1,963 participants (78.7 %). The median time to final interview was 20 months (interquartile range 15 to 28). In the IUD group, 56 out of 971 women (5.8 %) became pregnant during follow-up compared with 83 out of 992 women (8.4 %) in the IPC group (risk ratio (RR) 0.69, 95 % confidence interval (CI) 0.50 to 0.96; P = 0.025). There were no statistically significant differences between groups for the type of pregnancy outcome (Table 2).Fig. 1

Bottom Line: Pregnancy and discontinuation outcomes are reported here.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.The IUD was significantly more effective in preventing pregnancy than IPC.

View Article: PubMed Central - PubMed

Affiliation: Effective Care Research Unit, Eastern Cape Department of Health/Universities of the Witwatersrand, Walter Sisulu and Fort Hare, Mthatha, Eastern Cape, South Africa.

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).

No MeSH data available.


Related in: MedlinePlus