Evidence map›Paper›PMID 38134043›Full record

Trial reportPloS one2023

Misreporting contraceptive use and the association of peak study progestin levels with weight and BMI among women randomized to the progestin-only injectable contraceptives DMPA-IM and NET-EN.

Chanel Avenant, Alexis J Bick, Salndave B Skosana, Sigcinile Dlamini, Yusentha Balakrishna, Johnson Mosoko Moliki, Mandisa Singata-Madliki, G Justus Hofmeyr, Jenni Smit, Mags Beksinska and 7 more

Open access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2023. 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
2.6field-weighted citation impact, top 10% 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. Trial
  2. Trial
  3. Trial
  4. Article
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  6. Review
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

17 authors at 6 institutions in 3 countries.

Chanel AvenantDepartment of Molecular and Cell Biology, University of Cape Town, Cape Town, South Africa.
Alexis J BickDepartment of Molecular and Cell Biology, University of Cape Town, Cape Town, South Africa.
Salndave B SkosanaDepartment of Molecular and Cell Biology, University of Cape Town, Cape Town, South Africa.
Sigcinile DlaminiDepartment of Molecular and Cell Biology, University of Cape Town, Cape Town, South Africa.
Yusentha BalakrishnaBiostatistics Research Unit, South African Medical Research Council, Durban, South Africa.
Johnson Mosoko MolikiDepartment of Molecular and Cell Biology, University of Cape Town, Cape Town, South Africa.
Mandisa Singata-MadlikiEffective Care Research Unit, Eastern Cape Department of Health, Universities of the Witwatersrand and Fort Hare, East London, South Africa.
G Justus HofmeyrEffective Care Research Unit, Eastern Cape Department of Health, Universities of the Witwatersrand and Fort Hare, East London, South Africa.
Jenni SmitWits MRU (MatCH Research Unit), Department of Obstetrics and Gynecology, Faculty of Health Sciences, University of the Witwatersrand, Durban, South Africa.
Mags BeksinskaWits MRU (MatCH Research Unit), Department of Obstetrics and Gynecology, Faculty of Health Sciences, University of the Witwatersrand, Durban, South Africa.
Ivana BeeshamWits MRU (MatCH Research Unit), Department of Obstetrics and Gynecology, Faculty of Health Sciences, University of the Witwatersrand, Durban, South Africa.
Ishen SeocharanBiostatistics Research Unit, South African Medical Research Council, Durban, South Africa.
Joanne BattingEffective Care Research Unit, Eastern Cape Department of Health, Universities of the Witwatersrand and Fort Hare, East London, South Africa.
Pai-Lien ChenFamily Health International (FHI) 360, Durham, North Carolina, United States of America.
Karl-Heinz StorbeckDepartment of Biochemistry, Stellenbosch University, Stellenbosch, South Africa.ORCID 0000-0003-1669-6383
Donita AfricanderDepartment of Biochemistry, Stellenbosch University, Stellenbosch, South Africa.
Janet P HapgoodDepartment of Molecular and Cell Biology, University of Cape Town, Cape Town, South Africa.ORCID 0000-0002-4414-4861
University of Cape Town · ZAUniversity of the Witwatersrand · ZAWestern Cape Department of Health · ZASouth African Medical Research Council · ZAStellenbosch University · ZAFamily Health International 360 · US

Funding

Combination treatment for protection against HIV1 and pregnancyR01HD083026 · NICHD · UNIVERSITY OF CAPE TOWN · PI HAPGOOD, JANET PATRICIA, HEL, ZDENEK · 2015 to 2019
$2.5M
Biological effects, hormone levels and mechanisms relevant to HIV-1 infection for women randomized to the injectable contraceptives depo-medroxyprogesterone acetate or norethisterone enanthate.R01AI152118 · NIAID · UNIVERSITY OF CAPE TOWN · PI CHEN, PAI-LIEN, HAPGOOD, JANET PATRICIA · 2020 to 2024
$2.3M
NIAID NIH HHS R01 AI152118NICHD NIH HHS R01 HD083026
6 · The paper itself

Abstract

Progestin-only injectable contraceptives, mainly depo-medroxyprogesterone acetate intramuscular (DMPA-IM), are the most widely used contraceptive methods in sub-Saharan Africa. Insufficient robust data on their relative side-effects and serum concentrations limit understanding of reported outcomes in contraception trials. The WHICH clinical trial randomized HIV-negative women to DMPA-IM (n = 262) or norethisterone enanthate (NET-EN) (n = 259) at two South African sites between 2018-2019. We measured serum concentrations of study and non-study progestins at initiation (D0) and peak serum levels, one week after the 24-week injection [25 weeks (25W)], (n = 435) and investigated associations between study progestin levels, and BMI and weight of participants. Peak median serum concentrations were 6.59 (IQR 4.80; 8.70) nM for medroxyprogesterone (MPA) (n = 161) and 13.6 (IQR 9.01; 19.0) nM for norethisterone (NET) (n = 155). MPA was the most commonly quantifiable non-study progestin at D0 in both arms (54%) and at 25W in the NET-EN arm (27%), followed by NET at D0 in both arms (29%) and at 25W in the DMPA-IM arm (19%). Levonorgestrel was quantifiable in both arms [D0 (6.9%); 25W (3.4%)], while other progestins were quantifiable in ≤ 14 participants. Significant negative time-varying associations were detected between MPA and NET concentrations and weight and BMI in both contraceptive arms and a significant increase was detected for peak serum progestin concentrations for normal weight versus obese women. Contraceptive-related reported outcomes are likely confounded by MPA, more so than NET, with reported DMPA-IM effects likely underestimated, at sites where DMPA-IM is widely used, due to misreporting of contraceptive use before and during trials, and 'tail' effects of DMPA-IM use more than six months before trial enrolment. Peak serum levels of MPA and NET are negatively associated with BMI and weight, suggesting another source of variability between trial outcomes and a potential increase in side-effects for normal weight versus overweight and obese women. Trail registration: The clinical trial was registered with the Pan African Clinical Trials Registry (PACTR 202009758229976).

Indexed as

Medroxyprogesterone AcetateProgestinsBody Mass IndexContraceptive AgentsFemaleHumansNorethindroneObesityContraceptive AgentsMedroxyprogesterone AcetateNorethindronenorethindrone enanthateProgestins

Identifiers

PMID38134043
PMCPMC10745193
OpenAlexW4390100302

What OpenQuestion holds

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LicenceCC BY
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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.