Evidence map›Paper›PMID 33709288›Full record

Observational studyPituitary2021

Pregnancy outcomes in women receiving growth hormone replacement therapy enrolled in the NordiNet® International Outcome Study (IOS) and the American Norditropin® Studies: Web-Enabled Research (ANSWER) Program.

Beverly M K Biller, Charlotte Höybye, Paul Carroll, Murray B Gordon, Anna Camilla Birkegård, Nicky Kelepouris, Navid Nedjatian, Matthias M Weber

2 registry-linked trialsOpen access · hybridAbstract readObservational Study
In one paragraph

Observational study in Pituitary, 2021. 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 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 22% 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.

NCT00960128 completednot on this map

NordiNet® International Outcome Study-Observational Prospective Study on Patients Treated With Norditropin®

TypeobservationalSponsorNovo Nordisk A/SRan2006 to 2016Enrolled21,249ConditionsGrowth Hormone Disorder, Growth Hormone Deficiency in Children, Adult Growth Hormone Deficiency, Genetic DisorderArmssomatropin
NCT01009905 completednot on this map

Registry of Patients Being Treated With Norditropin®, Recombinant Human Growth Hormone

TypeobservationalSponsorNovo Nordisk A/SRan2002 to 2016Enrolled22,960ConditionsGrowth Hormone Disorder, Pituitary Dwarfism, HypopituitarismArmssomatropin
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Fertility issues in hypopituitarism.Reviews in endocrine & metabolic disorders · 2024
    Review
  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

8 authors at 8 institutions in 6 countries.

Beverly M K BillerNeuroendocrine Unit, Massachusetts General Hospital, Bulfinch 457B, Fruit St., Boston, MA, 02114, USA. BBILLER@mgh.harvard.edu.ORCID http://orcid.org/0000-0003-4359-4622
Charlotte HöybyeDepartment of Endocrinology, and Department of Molecular Medicine and Surgery, Karolinska University Hospital and Karolinska Institute, Stockholm, Sweden.ORCID http://orcid.org/0000-0002-3980-1927
Paul CarrollDepartment of Endocrinology, Guy's & St. Thomas' NHS Foundation Trust, London, UK.ORCID http://orcid.org/0000-0002-3864-8721
Murray B GordonAllegheny Neuroendocrinology Center, Division of Endocrinology, Allegheny General Hospital, Pittsburgh, PA, USA.ORCID http://orcid.org/0000-0001-9185-9424
Anna Camilla BirkegårdEpidemiology, Novo Nordisk A/S, Søborg, Denmark.ORCID http://orcid.org/0000-0003-2968-5798
Nicky KelepourisNovo Nordisk Inc., Plainsboro, NJ, USA.ORCID http://orcid.org/0000-0003-2445-2338
Navid NedjatianGlobal Medical Affairs - Rare Endocrine Disorders, Novo Nordisk Health Care AG, Zurich, Switzerland.ORCID http://orcid.org/0000-0002-0290-9803
Matthias M WeberUnit of Endocrinology, Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz, Germany.ORCID http://orcid.org/0000-0002-6939-2255
Allegheny General Hospital · USGuy's and St Thomas' NHS Foundation Trust · GBJohannes Gutenberg University Mainz · DEKarolinska University Hospital · SEMassachusetts General Hospital · USNovo Nordisk (Denmark) · DKNovo Nordisk (Switzerland) · CHNovo Nordisk (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeData on the safety of growth hormone (GH) replacement therapy during pregnancy are limited. We report a combined analysis of data from pregnant women treated with GH while enrolled in two non-interventional, multicenter studies: NordiNet® International Outcome Study (IOS) and the American Norditropin® Studies: Web-Enabled Research (ANSWER) Program.

methodsPregnancy data were pooled from NordiNet® IOS and the ANSWER Program. Data were collected during routine clinic visits by participating physicians using a web-based system. Patients exposed to GH replacement therapy during pregnancy were included in the analysis.

resultsThe study population included 40 female patients with typical causes of adult GH deficiency (GHD). Overall, there were 54 pregnancies. Of these, 47 were exposed to GH between conception and delivery. In 48.9% of pregnancies exposed to GH, the dose was > 0.6 mg/day. GH was continued past conception and then stopped during the first, second, and third trimester, in 27.7%, 17.0%, and 2.1% of pregnancies, respectively. In 29.8%, GH was continued throughout pregnancy, with an unchanged dose in most cases. Of the 47 GH-exposed pregnancies, 37 (78.7%) progressed to normal delivery. There were three adverse events reported in two pregnancies.

conclusionThese real-world data suggest that there were no new safety signals related to GH exposure in women with GHD during pregnancy. These results are consistent with findings from previous studies reporting data in pregnancies exposed to GH at conception or throughout pregnancy. This observational study in additional pregnancies provides further evidence that GH exposure does not adversely affect pregnancy outcome. CLINICAL

trial registrationClinicalTrials.gov NCT00960128 (date of registration: August 13, 2009) and NCT01009905 (date of registration: November 5, 2009).

Indexed as

Hormone Replacement TherapyDwarfism, PituitaryFemaleGrowth HormoneHuman Growth HormoneHumansInsulin-Like Growth Factor IOutcome Assessment, Health CarePregnancyPregnancy OutcomeUnited StatesGrowth HormoneHuman Growth HormoneInsulin-Like Growth Factor IAdult growth hormone deficiencyHuman growth hormoneIGF-IOutcomePregnancy

Identifiers

PMID33709288
PMCPMC8270875
OpenAlexW3080947280

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.