Back to resultsMetformin in Pregnant PCOS Women (PregMet)
Primary Purpose
Polycystic Ovary Syndrome
Status
Completed
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
Metformin
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Polycystic Ovary Syndrome focused on measuring PCOS, metformin, pregnancy, preeclampsia, diabetes, preterm delivery
Eligibility Criteria
Inclusion Criteria: 18-45 years, PCOS diagnosis according to Rotterdam criteria single, viable, ultrasound verified fetus if metformin was used at conception and early pregnancy, at least 7 days of "wash out" Exclusion Criteria: known liver disease or ALAT > 90 nmol/L known renal disease or creatinine > 110 micromol/L diabetes mellitus alcohol or drug abuse peroral steroid treatment cimetidine, anticoagulant or erythromycin treatment at time of inclusion not suitable for other reasons
Sites / Locations
- University hospital of Bergen
- Central Hospital of Northern Norway
- Buskerud Hospital
- Haugesund Hospital
- Ringerike Hospital
- Elvebredden Gynekologpraksis
- Lillehammer Hospital
- Stavanger University Hospital
- Departments of Obstetrics and Gynecology and Endocrinology, St. Olav's Hospital
- Ålesund Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Metformin
placebo
Arm Description
Metformin 1000mg x 2 daily
Placebo x 2 daily
Outcomes
Primary Outcome Measures
Gestational diabetes
incidence of metabolic syndrome and neurophysiologic parameters in offspring
Preterm delivery
pre-eclampsia
Secondary Outcome Measures
emesis and hyperemesis
Breastfeeding
weight change
blood pressure change
Incident of instrumental deliveries
Hormone levels in mother and offspring
Snoring and sleep quality
Full Information
NCT ID
NCT00159536
First Posted
September 8, 2005
Last Updated
February 11, 2019
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00159536
Brief Title
Metformin in Pregnant PCOS Women
Acronym
PregMet
Official Title
Metformin Treatment of Pregnant Women With Polycystic Ovary Syndrome (PCOS)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To investigate the effect of metformin on pregnancy complications and pregnancy outcome in the II. and III. trimester of pregnancy in women with polycystic ovary syndrome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
PCOS, metformin, pregnancy, preeclampsia, diabetes, preterm delivery
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
257 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metformin
Arm Type
Experimental
Arm Description
Metformin 1000mg x 2 daily
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo x 2 daily
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
metformin from Weifa 500 mg / tablet
Intervention Description
Metformin 1000 mg x 2 per day. Orally. From inclusion (before gestational week 12) to delivery. Verbal and written diet and lifestyle advices at inclusion to the study
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo from Weifa
Intervention Description
Placebo, 2 tablets x 2 daily.Orally. From inclusion (that is before gestational week 12) to delivery. Verbal and written diet and lifestyle advices at inclusion to the study
Primary Outcome Measure Information:
Title
Gestational diabetes
Time Frame
up to delivery
Title
incidence of metabolic syndrome and neurophysiologic parameters in offspring
Time Frame
Within 18 years
Title
Preterm delivery
Time Frame
up to delivery
Title
pre-eclampsia
Time Frame
up to delivery
Secondary Outcome Measure Information:
Title
emesis and hyperemesis
Time Frame
up to delivery
Title
Breastfeeding
Time Frame
One year post partum
Title
weight change
Time Frame
up to delivery
Title
blood pressure change
Time Frame
up to delivery
Title
Incident of instrumental deliveries
Time Frame
at delivery
Title
Hormone levels in mother and offspring
Time Frame
up to delivery
Title
Snoring and sleep quality
Time Frame
up to delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-45 years,
PCOS diagnosis according to Rotterdam criteria
single, viable, ultrasound verified fetus
if metformin was used at conception and early pregnancy, at least 7 days of "wash out"
Exclusion Criteria:
known liver disease or ALAT > 90 nmol/L
known renal disease or creatinine > 110 micromol/L
diabetes mellitus
alcohol or drug abuse
peroral steroid treatment
cimetidine, anticoagulant or erythromycin treatment at time of inclusion
not suitable for other reasons
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eszter I Vanky, MD, PhD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital of Bergen
City
Bergen
Country
Norway
Facility Name
Central Hospital of Northern Norway
City
Bodø
Country
Norway
Facility Name
Buskerud Hospital
City
Drammen
Country
Norway
Facility Name
Haugesund Hospital
City
Haugesund
Country
Norway
Facility Name
Ringerike Hospital
City
Hønefoss
Country
Norway
Facility Name
Elvebredden Gynekologpraksis
City
Kristiansand
Country
Norway
Facility Name
Lillehammer Hospital
City
Lillehammer
Country
Norway
Facility Name
Stavanger University Hospital
City
Stavanger
Country
Norway
Facility Name
Departments of Obstetrics and Gynecology and Endocrinology, St. Olav's Hospital
City
Trondheim
Country
Norway
Facility Name
Ålesund Hospital
City
Ålesund
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
29659896
Citation
Underdal MO, Stridsklev S, Oppen IH, Hogetveit K, Andersen MS, Vanky E. Does Metformin Treatment During Pregnancy Modify the Future Metabolic Profile in Women With PCOS? J Clin Endocrinol Metab. 2018 Jun 1;103(6):2408-2413. doi: 10.1210/jc.2018-00485.
Results Reference
background
PubMed Identifier
20926533
Citation
Vanky E, Stridsklev S, Heimstad R, Romundstad P, Skogoy K, Kleggetveit O, Hjelle S, von Brandis P, Eikeland T, Flo K, Berg KF, Bunford G, Lund A, Bjerke C, Almas I, Berg AH, Danielson A, Lahmami G, Carlsen SM. Metformin versus placebo from first trimester to delivery in polycystic ovary syndrome: a randomized, controlled multicenter study. J Clin Endocrinol Metab. 2010 Dec;95(12):E448-55. doi: 10.1210/jc.2010-0853. Epub 2010 Oct 6.
Results Reference
result
PubMed Identifier
22154766
Citation
Vanky E, Carlsen SM. Androgens and antimullerian hormone in mothers with polycystic ovary syndrome and their newborns. Fertil Steril. 2012 Feb;97(2):509-15. doi: 10.1016/j.fertnstert.2011.11.021. Epub 2011 Dec 10.
Results Reference
result
PubMed Identifier
26835542
Citation
Shetelig Lovvik T, Stridsklev S, Carlsen SM, Salvesen O, Vanky E. Cervical Length and Androgens in Pregnant Women With Polycystic Ovary Syndrome: Has Metformin Any Effect? J Clin Endocrinol Metab. 2016 Jun;101(6):2325-31. doi: 10.1210/jc.2015-3498. Epub 2016 Feb 2.
Results Reference
result
PubMed Identifier
29490031
Citation
Hanem LGE, Stridsklev S, Juliusson PB, Salvesen O, Roelants M, Carlsen SM, Odegard R, Vanky E. Metformin Use in PCOS Pregnancies Increases the Risk of Offspring Overweight at 4 Years of Age: Follow-Up of Two RCTs. J Clin Endocrinol Metab. 2018 Apr 1;103(4):1612-1621. doi: 10.1210/jc.2017-02419.
Results Reference
result
PubMed Identifier
30704873
Citation
Hanem LGE, Salvesen O, Juliusson PB, Carlsen SM, Nossum MCF, Vaage MO, Odegard R, Vanky E. Intrauterine metformin exposure and offspring cardiometabolic risk factors (PedMet study): a 5-10 year follow-up of the PregMet randomised controlled trial. Lancet Child Adolesc Health. 2019 Mar;3(3):166-174. doi: 10.1016/S2352-4642(18)30385-7. Epub 2019 Jan 29.
Results Reference
result
PubMed Identifier
35265033
Citation
Trouva A, Alvarsson M, Calissendorff J, Asvold BO, Vanky E, Hirschberg AL. Thyroid Status During Pregnancy in Women With Polycystic Ovary Syndrome and the Effect of Metformin. Front Endocrinol (Lausanne). 2022 Feb 21;13:772801. doi: 10.3389/fendo.2022.772801. eCollection 2022.
Results Reference
derived
PubMed Identifier
34529073
Citation
Stokkeland LMT, Giskeodegard GF, Ryssdal M, Jarmund AH, Steinkjer B, Madssen TS, Stafne SN, Stridsklev S, Lovvik TS, Iversen AC, Vanky E. Changes in Serum Cytokines Throughout Pregnancy in Women With Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2022 Jan 1;107(1):39-52. doi: 10.1210/clinem/dgab684.
Results Reference
derived
PubMed Identifier
32866967
Citation
Andrae F, Abbott D, Stridsklev S, Schmedes AV, Odsaeter IH, Vanky E, Salvesen O. Sustained Maternal Hyperandrogenism During PCOS Pregnancy Reduced by Metformin in Non-obese Women Carrying a Male Fetus. J Clin Endocrinol Metab. 2020 Dec 1;105(12):3762-70. doi: 10.1210/clinem/dgaa605.
Results Reference
derived
PubMed Identifier
32039724
Citation
Greger HK, Hanem LGE, Ostgard HF, Vanky E. Cognitive function in metformin exposed children, born to mothers with PCOS - follow-up of an RCT. BMC Pediatr. 2020 Feb 10;20(1):60. doi: 10.1186/s12887-020-1960-2.
Results Reference
derived
PubMed Identifier
31613965
Citation
Underdal MO, Salvesen O, Henriksen AH, Andersen M, Vanky E. Impaired Respiratory Function in Women With PCOS Compared With Matched Controls From a Population-Based Study. J Clin Endocrinol Metab. 2020 Jan 1;105(1):dgz053. doi: 10.1210/clinem/dgz053.
Results Reference
derived
PubMed Identifier
30186323
Citation
Stridsklev S, Salvesen O, Salvesen KA, Carlsen SM, Vanky E. Uterine Artery Doppler in Pregnancy: Women with PCOS Compared to Healthy Controls. Int J Endocrinol. 2018 Aug 16;2018:2604064. doi: 10.1155/2018/2604064. eCollection 2018.
Results Reference
derived
PubMed Identifier
29165598
Citation
Hjorth-Hansen A, Salvesen O, Engen Hanem LG, Eggebo T, Salvesen KA, Vanky E, Odegard R. Fetal Growth and Birth Anthropometrics in Metformin-Exposed Offspring Born to Mothers With PCOS. J Clin Endocrinol Metab. 2018 Feb 1;103(2):740-747. doi: 10.1210/jc.2017-01191.
Results Reference
derived
PubMed Identifier
25282112
Citation
Christiansen SC, Vanky E, Klungland H, Stafne SN, Morkved S, Salvesen KA, Saether M, Carlsen SM. The effect of exercise and metformin treatment on circulating free DNA in pregnancy. Placenta. 2014 Dec;35(12):989-93. doi: 10.1016/j.placenta.2014.09.010. Epub 2014 Sep 23.
Results Reference
derived
PubMed Identifier
24595965
Citation
Helseth R, Vanky E, Stridsklev S, Vogt C, Carlsen SM. Maternal and fetal insulin levels at birth in women with polycystic ovary syndrome: data from a randomized controlled study on metformin. Eur J Endocrinol. 2014 Apr 10;170(5):769-75. doi: 10.1530/EJE-13-0859. Print 2014 May.
Results Reference
derived
PubMed Identifier
23071212
Citation
Carlsen SM, Martinussen MP, Vanky E. Metformin's effect on first-year weight gain: a follow-up study. Pediatrics. 2012 Nov;130(5):e1222-6. doi: 10.1542/peds.2012-0346. Epub 2012 Oct 15.
Results Reference
derived
Learn more about this trial
Metformin in Pregnant PCOS Women
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