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A Prospective, Randomized, Double-blind, Multi-centre Study, Where the Possible Effect of Metformin to Prevent Late Miscarriage and Preterm Delivery is Studied in Women With Polycystic Ovary Syndrome (PCOS)


N/A
18 Years
45 Years
Open (Enrolling)
Female
Pregnancy, Polycystic Ovary Syndrome

Thank you

Trial Information

A Prospective, Randomized, Double-blind, Multi-centre Study, Where the Possible Effect of Metformin to Prevent Late Miscarriage and Preterm Delivery is Studied in Women With Polycystic Ovary Syndrome (PCOS)


Inclusion Criteria:



- Age: 18-45 years

- PCOS diagnosed or reconfirmed according to Rotterdam 2003 criteria, not more than 5
years prior to inclusion

- Mode of conception: Any

- Single, viable fetus, diagnosed by vaginal ultrasound

- Gestational week at inclusion: week 6 + 0 to 12 + 0

- Wash out for metformin: at least 7 days

- Able to communicate fluently in the official language at the study cite or English

Exclusion Criteria:

- Any type of diabetes (except GDM in former pregnancy)

- Known liver disease or ALAT > 100 IU/L

- Known kidney disease or creatinine > 110 ╬╝mol/L

- Known alcohol or drug abuse

- Use of drugs interfering with metformin: erytromycin (or other macrolides),
cimetidine, anticoagulation therapy

- Unsuitable for participation of other reasons

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

combined incidence of late miscarriages and preterm births

Outcome Description:

This includes spontaneous births, induced vaginal deliveries and operative deliveries on medical indications.

Outcome Time Frame:

at delivery

Safety Issue:

No

Principal Investigator

Eszter I Vanky, md phd

Investigator Role:

Study Director

Investigator Affiliation:

Norwegian University of Science and Technology

Authority:

Norway:National Committee for Medical and Health Research Ethics

Study ID:

2011/1434

NCT ID:

NCT01587378

Start Date:

October 2012

Completion Date:

March 2016

Related Keywords:

  • Pregnancy
  • Polycystic Ovary Syndrome
  • miscarriage
  • preterm birth
  • prevention
  • Abortion, Spontaneous
  • Polycystic Ovary Syndrome
  • Premature Birth

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