NCT02802215

Brief Summary

Randomized, placebo controlled clinical trial that evaluate the role of taking metformin therapy during pregnancy in women with polycystic ovarian syndrome(PCOS) in reducing the development of gestational diabetes(GDM) and improving pregnancy outcomes.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 16, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

June 16, 2016

Status Verified

December 1, 2015

Enrollment Period

7 months

First QC Date

May 7, 2016

Last Update Submit

June 15, 2016

Conditions

Polycystic Ovary SyndromeDiabetes, Gestational

Keywords

Diabetes MellitusPregnancy

Outcome Measures

Primary Outcomes (1)

  • Number of participants with gestational diabetes by measuring plasma glucose levels ( mg / dl ).

    Diagnosis of GDM when these values are met or exceed fasting plasma glucose level (92 mg/dl).1hr level is (180 mg/dl) and 2hrs level is (153 mg/dl).

    24th -28th week gestation

Secondary Outcomes (2)

  • Fetal adverse effects

    from 12th week gestation till delivery

  • Maternal adverse effects

    from 12th week gestation till delivery

Study Arms (2)

Metformin group

ACTIVE COMPARATOR

40 women will receive metformin in dose of 1500 mg per day orally (500 mg every 8 hrs in the middle of meal) starting from 12th week of gestation till delivery.

Drug: metformin

control group

PLACEBO COMPARATOR

40 women will receive placebo which will be folic acid 500 micro gram which looks like metformin tablet.

Drug: placebo (folic acid )

Interventions

metforminDRUG

Metformin group will receive 1500 mg of metformin per day orally ( 500 mg every 8hrs in the middle of meal) starting from 12th week of gestation till delivery.

Also known as: cidophage
Metformin group
placebo (folic acid )DRUG

500 micro gram of folic acid every 8 hrs

Also known as: folicap
control group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All women had confirmed diagnosis of PCOS before pregnancy according to revised 2003 Rotterdam criteria.
  • Age more than 20 and more than 40 years.
  • BMI ranging from (25\_35 )
  • Written and signed informed consent is given from the patient to participate in the study.

You may not qualify if:

  • Women with pre-gestational diabetes mellitus confirmed by 2hrs OGTT.
  • Patients who take metformin in the first 12 wk of pregnancy.
  • Patients who are unwilling to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams maternity hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary SyndromeDiabetes, GestationalDiabetes Mellitus

Interventions

MetforminFolic Acid

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesPregnancy ComplicationsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Ahmed E elbohoty, MD

    Ain Shams University

    PRINCIPAL INVESTIGATOR

  • Reda k Mokhtar, MD

    Ain Shams University

    PRINCIPAL INVESTIGATOR

  • mai R ibrahim, MBBCH

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed E elbohoty, MD

CONTACT

elbohoty79@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Obstetric and Gynecology Faculty of medicine Ain Shams University

Study Record Dates

First Submitted

May 7, 2016

First Posted

June 16, 2016

Study Start

January 1, 2016

Primary Completion

August 1, 2016

Study Completion

September 1, 2016

Last Updated

June 16, 2016

Record last verified: 2015-12

Data Sharing

IPD Sharing
Will share

Locations

EG(1)