Evidence map›Paper›PMID 31409287›Full record

Observational studyBMC pregnancy and childbirth2019

Rationale and design of two prospective, multicenter, observational studies on reproductive outcome in women with recurrent failures after spontaneous or assisted conception: OTTILIA and FIRST registries.

Michela Villani, Domenico Baldini, Pasquale Totaro, Giovanni Larciprete, Mirjana Kovac, Domenico Carone, Serena Maria Passamonti, Eleonora Tamborini Permunian, Tiziana Bartolotti, Andrea Lojacono and 10 more

2 registry-linked trialsAbstract readMulticenter StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in BMC pregnancy and childbirth, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT02385461 unknown statusnot on this map

A Proposal of a Prospective Study on Prevention of Pregnancy Loss in Women Carrying Inherited Thrombophilia

Typeobservational_patient_registrySponsorCasa Sollievo della Sofferenza IRCCSRan2012 to 2020Enrolled108ConditionsPregnancy ComplicationsArmsLow Molecular Weight Heparins (LMWHs)
NCT02685800 unknown statusnot on this map

A Registry on Outcomes in Women Undergoing Assisted Reproductive Techniques After Recurrent Failures

Typeobservational_patient_registrySponsorCasa Sollievo della Sofferenza IRCCSRan2015 to 2020Enrolled624ConditionsInfertility
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Observational
  3. 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

20 authors.

Michela VillaniThrombosis and Haemostasis Unit, I.R.C.C.S. "Casa Sollievo della Sofferenza" Poliambulatorio Giovanni Paolo II, Viale Padre Pio, San Giovanni Rotondo, Italy.
Domenico BaldiniCentro di Fecondazione Medicalmente Assistita MoMò Fertilife, Bisceglie, Italy.
Pasquale TotaroCentro PMA "Casa di Cura Santa Maria", Bari, Italy.
Giovanni LarcipreteDepartment of Obstetrics and Gynecology, Fatebenefratelli Isola Tiberina Hospital, Rome, Italy.
Mirjana KovacBlood Transfusion Institute of Serbia, Belgrade, Serbia.
Domenico CaroneCenter of Reproduction and Andrology (CREA), Taranto, Italy.
Serena Maria PassamontiA. Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico, Milan, Italy.
Eleonora Tamborini PermunianDepartment of Clinical Medicine, Insubria University, Varese, Italy.
Tiziana BartolottiCentro PMA "ARTeBIOS", Lugo, Ravenna, Italy.
Andrea LojaconoObstetrics and Gynecology, Department of Clinical and Experimental Sciences, ASST Spedali Civili and University of Brescia, Brescia, Italy.
Rossella CacciolaHaemostasis Unit, Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy.
Giuliano Lo PintoDepartment of Internal Medicine, Galliera Hospital, Genoa, Italy.
Eugenio BucheriniUnit of Vascular Medicine and Angiology, Civic Hospital of Faenza, Faenza, Italy.
Valerio De StefanoInstitute of Hematology, Catholic University, Rome, Italy.
Corrado LodigianiThrombosis and Hemorrhagic Center, Humanitas Research Hospital and Humanitas University, Rozzano, Italy.
Cristina LavopaCentro di Fecondazione Medicalmente Assistita MoMò Fertilife, Bisceglie, Italy.
Yoon Sung ChoCentro PMA "Casa di Cura Santa Maria", Bari, Italy.
Caterina PizzicaroliDepartment of Obstetrics and Gynecology, Fatebenefratelli Isola Tiberina Hospital, Rome, Italy.
Donatella ColaizzoThrombosis and Haemostasis Unit, I.R.C.C.S. "Casa Sollievo della Sofferenza" Poliambulatorio Giovanni Paolo II, Viale Padre Pio, San Giovanni Rotondo, Italy.
Elvira GrandoneThrombosis and Haemostasis Unit, I.R.C.C.S. "Casa Sollievo della Sofferenza" Poliambulatorio Giovanni Paolo II, Viale Padre Pio, San Giovanni Rotondo, Italy. e.grandone@operapadrepio.it.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSpontaneous pregnancy loss and implantation failure after assisted reproductive technologies (ART) are very common occurrences. Although 50-60% of all cases remains unexplained, various predisposing factors, including thrombophilias, have been identified. Thus, the potential benefit of a prophylaxis with low-molecular-weight heparins in improving outcomes has been often investigated over the years. However, the majority of studies are observational and results from randomized clinical trials (RCTs) are inconclusive, probably due to heterogeneity and limited sample size. To cover these unmet needs and to have further data mainly based on the real-life clinical management, we designed these multicenter registries.

methodsOTTILIA (Observational sTudy on antiThrombotic prevention in thrombophILIA and pregnancy loss) and FIRST (recurrent Failures in assIsted Reproductive Techniques) registries are two prospective, multicenter, observational studies to evaluate pregnancy or ART outcomes in consecutive women with previous reproductive failures after spontaneous or assisted conception, respectively. All enrolled women are observed from their first visit after positive pregnancy test (OTTILIA) or before commencing a new ART cycle (FIRST) until the end of pregnancy or ART procedure (negative pregnancy test/end of pregnancy, if successful cycle), respectively. Data are collected by means of questionnaires and recorded in a central database. Follow-up investigations are performed during hospital stay, routine clinical follow-up visits or telephone interviews. Primary outcome is live birth rate in the OTTILIA register and clinical pregnancy rate in the FIRST. DISCUSSION: Although RCTs are the 'gold standard' for evaluating treatment outcomes, we believe that our registries represent a valid alternative in improving knowledge on mechanisms involved in reproductive failures and supporting future clinical decisions.

trial registrationNCT02385461 , retrospectively registered 5 March 2015 (OTTILIA); NCT02685800 , registered 10 February 2016 (FIRST).

Indexed as

RegistriesReproductive Techniques, AssistedAbortion, HabitualAnticoagulantsFemaleHeparin, Low-Molecular-WeightHumansLive BirthPregnancyPregnancy RateProspective StudiesThrombophiliaTreatment FailureAnticoagulantsHeparin, Low-Molecular-WeightAssisted reproductive technologiesHeparinsImplantation failureObservational studyPregnancy lossRisk factorsThrombophilia

Identifiers

PMID31409287
PMCPMC6693203

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Registered trials

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.