Orchestra Pregnancy Observational Study in Poland

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Medtronic Poland Spółka z ograniczoną odpowiedzialnością
Sponsor:
Information provided by (Responsible Party):
Medtronic Poland Spółka z ograniczoną odpowiedzialnością
ClinicalTrials.gov Identifier:
NCT01779141
First received: January 28, 2013
Last updated: May 30, 2014
Last verified: May 2014

January 28, 2013
May 30, 2014
May 2013
December 2015   (final data collection date for primary outcome measure)
HbA1c [ Time Frame: 16 months ] [ Designated as safety issue: No ]
Maternal glycemic control
Same as current
Complete list of historical versions of study NCT01779141 on ClinicalTrials.gov Archive Site
Assessment of prevalence of pregnancy complications and neonatal outcomes [ Time Frame: During pregnancy, at delivery and 6 weeks after delivery ] [ Designated as safety issue: No ]
Mode of delivery (rates elective and emergency CS, normal), Respiratory distress (1 and 5 minute Apgar scores), Gestational age at delivery, % preterm delivery <37 weeks, Infant birth weight (SD scores and customised birth weight percentile, % large for gestational age (LGA), % small for gestational age (SGA), Neonatal morbidity (treatment for neonatal hypoglycaemia), Neonatal care admission (duration of stay, level of care), Pregnancy related serious adverse events (miscarriage <22 weeks, congenital malformation, stillbirth, neonatal death), Feeding at hospital discharge (breast, bottle, both)
  • Pregnancy complications [ Time Frame: During pregnacy and 6 weeks after delivery ] [ Designated as safety issue: No ]
    Rates of preterm delivery, infant birth weight, neonatal care admissions
  • Neonatal outcomes [ Time Frame: During pregnancy, at delivery and 6 weeks after delivery ] [ Designated as safety issue: No ]
    • Mode of delivery (rates elective and emergency CS, normal)
    • Respiratory distress (1 and 5 minute Apgar scores)
    • Gestational age at delivery, % preterm delivery <37 weeks
    • Infant birth weight (SD scores and customised birth weight percentile, % large for gestational age (LGA), % small for gestational age (SGA)
    • Neonatal morbidity (treatment for neonatal hypoglycaemia)
    • Neonatal care admission (duration of stay, level of care)
    • Pregnancy related serious adverse events (miscarriage <22 weeks, congenital malformation, stillbirth, neonatal death)
    • Feeding at hospital discharge (breast, bottle, both)
  • Patient reported outcomes [ Time Frame: 16 months ] [ Designated as safety issue: No ]
    To evaluate change in patient-reported outcomes using the Hypoglycemia Fear Survey (HFS) and the Diabetes Treatment Satisfaction Questionnaire (DTSQs and DTSQc)
Not Provided
Not Provided
 
Orchestra Pregnancy Observational Study in Poland
A Multi-center Observational Study During Pregnancy for Women With T1DM Treated With the Paradigm Insulin Pumps Donated by the 'Wielka Orkiestra Świątecznej Pomocy' Foundation in Poland

Purpose:

The aim of this observational study (registry) is to document the use of insulin pump therapy (CSII) and sensor augmented pump therapy (SAP) before, during and after pregnancy in women with Type 1 Diabetes Mellitus benefiting from the Orchestra donation of Paradigm REAL-Time and Paradigm Veo pumps in Poland.

Objectives:

To assess the benefits of CSII and SAP on the maternal glycemic control; To assess the prevalence of pregnancy complications (rates of preterm delivery, infant birth weight, neonatal care admissions) from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks); To report and assess the potential benefits of SAP or CSII on neonatal outcomes

Not Provided
Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
16 Months
Retention:   None Retained
Description:

Whole blood, serum, urine samples as required in routine practice before, during and after pregnancy in women with Type 1 Diabetes Mellitus

Probability Sample

Women with Type 1 Diabetes Mellitus planning pregnancy or being pregnant until the 16th week of pregnacy

  • Type 1 Diabetes Mellitus
  • Pregnancy
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
January 2016
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female Diagnosed with Diabetes Mellitus Type 1
  • Subject indicated by Health Care Provider (HCP) to start insulin pump therapy (CSII) or sensor augmented pump therapy (SAP) due to the desired or established pregnancy
  • HCP has prescribed the use of Orchestra donated device to the subject independently of the study
  • Signed Patient Informed Consent (PIC)
  • Subject is 18 to 45 years old, planning immediate pregnancy (within the next 6 months) or being pregnant within the first trimester until the 16th week of amenorrhea
  • Subject has been on Multiple Daily Injections (MDI) for at least 3 months (before pre-conception phase), except following a miscarriage and trying another pregnancy

Exclusion Criteria:

  • Participation in any other clinical trial - currently and/or in the last 3 months before the signature of PIC
  • Subject uses an insulin pump that was not donated by the Orchestra foundation
  • Use of contraception during insulin pump therapy
  • Pregnant women with longer than 16 weeks of pregnancy/amenorrhea
  • Subjects who need assisted in vitro fertilization
  • Subjects with Diabetes Mellitus Type 2
  • Subjects with Gestational Diabetes or MODY
  • Subject under the age of 18
  • Subject legally incompetent
  • Subject cannot read or write
Female
18 Years to 45 Years
No
Poland
 
NCT01779141
PL01
No
Medtronic Poland Spółka z ograniczoną odpowiedzialnością
Medtronic Poland Spółka z ograniczoną odpowiedzialnością
Not Provided
Principal Investigator: Jacek Sieradzki, Professor Cracow Medical University
Medtronic Poland Spółka z ograniczoną odpowiedzialnością
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP