Evidence map›Paper›PMID 32494772›Full record

ArticleContraception: X2019

Randomized trial to evaluate contraceptive efficacy, safety and acceptability of a two-rod contraceptive implant over 4 years in the Dominican Republic.

M J Steiner, V Brache, D Taylor, R Callahan, V Halpern, A Jorge, S Wevill, J Sergison, L Venkatasubramanian, L Dorflinger

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Contraception: X, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.3field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 9 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 2 institutions in 2 countries.

M J SteinerContraceptive Technology Innovation Division, FHI 360, 359 Blackwell Street, Durham, NC 27701, USA.
V BracheAsociación Dominicana Pro Bienestar de la Familia, Inc. (PROFAMILIA), Santo Domingo, Dominican Republic.
D TaylorContraceptive Technology Innovation Division, FHI 360, 359 Blackwell Street, Durham, NC 27701, USA.
R CallahanContraceptive Technology Innovation Division, FHI 360, 359 Blackwell Street, Durham, NC 27701, USA.
V HalpernContraceptive Technology Innovation Division, FHI 360, 359 Blackwell Street, Durham, NC 27701, USA.
A JorgeAsociación Dominicana Pro Bienestar de la Familia, Inc. (PROFAMILIA), Santo Domingo, Dominican Republic.
S WevillContraceptive Technology Innovation Division, FHI 360, 359 Blackwell Street, Durham, NC 27701, USA.
J SergisonContraceptive Technology Innovation Division, FHI 360, 359 Blackwell Street, Durham, NC 27701, USA.
L VenkatasubramanianContraceptive Technology Innovation Division, FHI 360, 359 Blackwell Street, Durham, NC 27701, USA.
L DorflingerContraceptive Technology Innovation Division, FHI 360, 359 Blackwell Street, Durham, NC 27701, USA.
Family Health International 360 · USProfamilia · DO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveSino-implant (II) is a contraceptive implant that had a commodity price one-third of the competing products a decade ago. To make Sino-implant (II) more widely available, we conducted a trial to collect safety and efficacy data required for World Health Organization (WHO) prequalification, a quality standard allowing global donors to procure a pharmaceutical product. STUDY

designThis was a randomized controlled trial allocating 650 participants to either Sino-implant (II) or Jadelle®. Participants were seen at 1 and 6 months, and then semiannually. The primary efficacy measure was the pregnancy Pearl Index [number of pregnancies per 100 women-years (WY) of follow-up] in the Sino-implant (II) group during up to 4 years of implant use.

resultsFor the primary outcome, Sino-implant (II) had a 4-year Pearl Index of 0.74 (95% confidence interval, 0.36-1.37) compared to 0.00 (95% confidence interval, 0.00-1.04) for Jadelle®. The Sino-implant (II) pregnancy rate was significantly higher in the fourth year (3.54 per 100 WY) than in the first 3 years combined (0.18 per 100 WY; p <.001). Total levonorgestrel concentrations were equivalent between groups at month 12, but were 19%, 22% and 32% lower in the Sino-implant (II) group at months 24, 36 and 48, respectively (p <.001 at each time point). Safety and acceptability of the two products were similar, while providers documented significantly higher breakage rates during removal of Sino-implant (II) (16.3% vs. 3.1%; p <.001).

conclusionBased on these results, WHO prequalified Sino-Implant (II) with a 3-year use label in June 2017, 2 years shorter than the 5-year duration of Jadelle®. IMPLICATIONS: WHO prequalification allows global donors to procure Sino-implant (II), which means women in many low resource countries will have greater access to highly effective and acceptable contraceptive implants. Our study noted important clinical differences, including shorter duration of high effectiveness with Sino-implant (II) when compared to the other available two-rod system, Jadelle®. Introduction strategies should include appropriate training on these differences.

Indexed as

Contraceptive effectiveness, safetyLevoplantLong-acting reversible contraceptiveSino-implant

Identifiers

PMID32494772
PMCPMC7252426
OpenAlexW2924013460

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.