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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.

Plain-language guide to PMID 27091008 (2016): open-label randomized controlled trial of Copper (Supplement) in 7,000 women.

Key Facts

PMID
27091008
Journal
Reproductive health
Year
2016
Study type
Randomized Controlled Trial
Authors
Hofmeyr GJ et al. (5 authors)
DOI
10.1186/s12978-016-0153-9

What This Study Did, in Plain Language

What Was Tested

The paper reports a study of Copper (Supplement), published as a randomized controlled trial.

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.

Who Took Part

The abstract describes 7,000 women taking part.

By PubMed's age tags, the people studied were teenagers, young adults and adults, women only.

The target sample size was 7,000 women and the randomisation ratio was 1:1.

Counselled, consenting women attending termination of pregnancy services were randomly assigned to IUD or IPC immediately post-termination.

How the Study Was Run

The researchers set it up as a randomized, open-label and parallel-group study.

The women were allocated by chance, so the Copper (Supplement) group and the comparison group should start out alike.

Nothing was hidden in this open-label Copper (Supplement) study: the women and staff both knew the treatment.

Groups ran in parallel: each of the women stayed in one arm throughout.

The random sequence was computer-generated and group allocation was concealed in sealed, opaque, consecutively-numbered envelopes.

The primary outcome was pregnancy; secondary outcomes were discontinuation, side-effects, and HIV acquisition and disease progression.

Pregnancy and discontinuation outcomes are reported here.

What Was Measured

The subject headings attached to it are Abdominal Pain, Abortion, Legal, Back Pain, Contraception Behavior, Contraceptive Agents, Female, Drug Implants and Early Termination of Clinical Trials.

The authors tagged it with the keywords DMPA, IUD and Random.

What This Means in Plain Language

The paper is a randomized, open-label and parallel-group study of Copper (Supplement) in 7,000 women.

With several hundred people or more, it is a fairly large study for this kind of research.

The abstract goes on to report its results in about 9 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2016 (Reproductive health), a journal based in England.

More context: the Copper (Supplement) compound page, all human trials.

Our Notes on the Compound

Copper (Supplement): The active site of cytochrome c oxidase is described as containing copper ions that are essential for electron transfer.

Related Pages

Source: PubMed record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.