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Orchestra Pregnancy Observational Study in Poland

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 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: October 15, 2014
Last verified: October 2014

January 28, 2013
October 15, 2014
May 2013
February 2017   (final data collection date for primary outcome measure)
HbA1c [ Time Frame: 22 months ] [ Designated as safety issue: No ]
Maternal glycemic control
HbA1c [ Time Frame: 16 months ] [ Designated as safety issue: No ]
Maternal glycemic control
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
22 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
350
May 2017
February 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female diagnosed with Diabetes Mellitus Type 1
  • Subject indicated by 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 12 months) or being pregnant within the first trimester until the 16th week of amenorrhea
  • Subject has been on MDI for at least 3 months before starting pump therapy

Exclusion Criteria:

  • Subject was enrolled in the registry earlier, and terminated it (for any reason)
  • Participation in any other interventional 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
  • Pregnant women with longer than 16 weeks of pregnancy/amenorrhea
  • Subjects who need assisted in vitro fertilization
  • Subjects with Diabetes Mellitus Type 2, Gestational Diabetes, MODY or any other type of diabetes than Type 1
  • Subject under the age of 18
  • Subject legally incompetent
  • Subject cannot read or write
Female
18 Years to 45 Years
No
Contact: Jacek Sieradzki, Prof ja.sieradzki@gmail.com
Contact: Katarzyna Cypryk, Prof kcypryk@mp.pl
Poland
 
NCT01779141
PL01
No
Medtronic Poland Spółka z ograniczoną odpowiedzialnością
Medtronic Poland Spółka z ograniczoną odpowiedzialnością
Not Provided
Study Chair: Jacek Sieradzki, Prof Cracow Medical University
Medtronic Poland Spółka z ograniczoną odpowiedzialnością
October 2014

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