Evidence map›Paper›PMID 36409333›Full record

Trial reportArchives of gynecology and obstetrics2023

Drospirenone 4 mg in a 24 + 4 regimen in women with contraindications to oestrogen use for contraception: bleeding patterns according to previous menstrual characteristics.

Giovanni Grandi, Maria Chiara Del Savio, Chiara Melotti, Fabio Facchinetti

Open access · greenAbstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in Archives of gynecology and obstetrics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 30% 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

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 3 citations in OpenAlex.

  1. Pooled it
  2. Trial
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

4 authors at 1 institution in 1 country.

Giovanni GrandiDepartment of Medical and Surgical Sciences for Mother, Child and Adult, Obstetrics and Gynecology Unit, University of Modena and Reggio Emilia, Azienda Ospedaliero Universitaria Policlinico, Via del Pozzo 71, 41124, Modena, Italy. giovanni.grandi@unimore.it.ORCID http://orcid.org/0000-0002-3567-3278
Maria Chiara Del SavioDepartment of Medical and Surgical Sciences for Mother, Child and Adult, Obstetrics and Gynecology Unit, University of Modena and Reggio Emilia, Azienda Ospedaliero Universitaria Policlinico, Via del Pozzo 71, 41124, Modena, Italy.
Chiara MelottiDepartment of Medical and Surgical Sciences for Mother, Child and Adult, Obstetrics and Gynecology Unit, University of Modena and Reggio Emilia, Azienda Ospedaliero Universitaria Policlinico, Via del Pozzo 71, 41124, Modena, Italy.
Fabio FacchinettiDepartment of Medical and Surgical Sciences for Mother, Child and Adult, Obstetrics and Gynecology Unit, University of Modena and Reggio Emilia, Azienda Ospedaliero Universitaria Policlinico, Via del Pozzo 71, 41124, Modena, Italy.
University of Modena and Reggio Emilia · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeA new POP consisting of 4 mg drospirenone (DRSP) for 24 days with a 4-day hormone-free interval was developed to improve bleeding predictability during POP use. The aim of this study was to evaluate the effect on bleeding patterns during use of this oral contraceptive (OC) in comparison with previous menstrual cycles before the start of OC use.

methodsThis is a pilot, prospective trial. A diary was used to collect information about daily bleeding and pelvic pain before and during treatment. During OC use, women were categorised as having (1) unscheduled bleeding or spotting days (UB), (2) scheduled bleeding or spotting days (SB) and (3) absence of bleeding/spotting (AB). SF-36 and FSFI questionnaires were used to quantify health-related quality of life and the quality of sexual life in sexually active participants.

resultsEighteen out of twenty-five (72%) women completed the entire follow-up. Women with UB (44.4%) were older at inclusion (p < 0.001) and had higher BMIs (p = 0.02) than those with AB (22.2%) or SB (33.4%). Women recorded a significant reduction of menstrual flow intensity during OC use (p < 0.0001). Those with UB also experienced a significant reduction of menstrual pain intensity (p = 0.006). Women with SB during OC use had a longer baseline cycle than those who reported UB during OC use (p = 0.008). Satisfaction with this OC was very high (8.4 ± 2.2 points) with no modification in SF-36 and FSFI values.

conclusionA DRSP-only pill is a good OC option for women with contraindications to oestrogen use. Features of the menstrual cycle before the start of OC use may be used to predict associated changes in bleeding patterns.

Indexed as

Contraceptives, OralQuality of LifeAndrostenesContraceptionContraceptives, Oral, CombinedContraindicationsEstrogensEthinyl EstradiolFemaleHumansMenstrual CyclePilot ProjectsProspective StudiesAndrostenesContraceptives, OralContraceptives, Oral, CombineddrospirenoneEstrogensEthinyl EstradiolBleedingDrospirenoneDysmenorrheaOral contraceptiveProgestin-only pill

Identifiers

PMID36409333
OpenAlexW4309506033

What OpenQuestion holds

Textmetadata
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.