Last updated: 03/08/2019 21:50:11
Observational Study to Assess Maternal and Fetal Outcomes Following Exposure to Albiglutide during Pregnancy
GSK study ID
207351
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
Official title: Observational Study to Assess Maternal and Fetal Outcomes Following Exposure to Albiglutide during Pregnancy
Trial description: There are no published controlled studies examining the safety of albiglutide in pregnancy. Subjects and prescribers need information on the safety of albiglutide in pregnancy in order to decide whether the benefits outweigh the potential risks. The objective of this study is to assess the safety of albiglutide in the developing fetus and in pregnant women. To determine whether exposure to albiglutide during specific gestational periods is associated with an increased risk of pre-specified obstetric and neonatal outcomes, the current study will quantify the risk in pregnancies exposed to albiglutide relative to unexposed women within a population-based cohort of pregnant women with clinically diagnosed pre-gestational type 2 diabetes. Completed pregnancies in women 12 to 55 years of age will be linked to live born infants. Strict eligibility criteria are then applied to ensure complete claim information for the mother and infant.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of spontaneous abortions
Timeframe: Up to 20 weeks post gestation
Number of childbirths
Timeframe: 20 Weeks to end of pregnancy
Number of live infants with major congenital malformations overall and specific classes of malformations
Timeframe: Delivery to 3 months post delivery
Number of live infants with Preterm delivery
Timeframe: Delivery to 1 month post delivery
Number of live infants with excessive fetal growth (macrosomia)
Timeframe: Delivery to 1 month post delivery
Number of live infants born small for gestational age (fetal growth retardation)
Timeframe: Delivery to 1 month post delivery
Number of pregnancies with pre-eclampsia
Timeframe: Delivery admission
Number of pregnancies with hypoglycemia
Timeframe: Delivery admission
Number of pregnancies with polyhydramnios
Timeframe: Delivery admission
Number of pregnancies ending in Cesarean delivery
Timeframe: Delivery admission
Number of pregnancies requiring induction of labor
Timeframe: Delivery admission
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
0
Primary completion date:
2021-01-01
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Diabetes Mellitus, Type 2
Product
albiglutide
Collaborators
Harvard T.H. Chan School of Public Health
Study date(s)
July 2019 to January 2021
Type
Observational
Phase
4
Participation criteria
Sex
Female
Age
12 - 55 Years
Accepts healthy volunteers
Not applicable
- Analysis for spontaneous abortions and stillbirths:
- Base cohort to include pregnancies drawn from the Truven database with a pregnancy outcome (spontaneous abortion, stillbirth or live birth) from 2014 onwards with pre-gestational type 2 diabetes.
- Analysis for spontaneous abortions and stillbirths:
- Termination of pregnancy (since these pregnancies will not be at risk for other outcomes).
Inclusion and exclusion criteria
Inclusion criteria:
- Analysis for spontaneous abortions and stillbirths:
- Base cohort to include pregnancies drawn from the Truven database with a pregnancy outcome (spontaneous abortion, stillbirth or live birth) from 2014 onwards with pre-gestational type 2 diabetes.
- Maternal eligibility for health care and prescriptions insurance from a) live births: 90 days months prior to the last menstrual period until 30 days post-delivery; b) abortions (spontaneous abortions): from 180 days prior to the first code for abortion to 30 days after this diagnosis and c) stillbirths: from 365 days prior to the first code for stillbirth to 30 days after this diagnosis. (The long baseline required for losses aims to include peri- last menstrual period (LMP) information under most timing scenarios.) Analysis for major malformations:
- Base cohort to include pregnancies drawn from the Truven database with linked offspring from 2014 onwards with pre-gestational type 2 diabetes (Only live births included since information from pathology of pregnancy losses or as indication for termination is rarely recorded, however, the proportion of pregnancy losses will be considered in sensitivity analyses.)
- Maternal eligibility for health care and prescriptions insurance from 90 days prior to the last menstrual period until 30 days post delivery.
- Offspring eligibility from delivery to 90 days after the delivery, unless the infant died prior to the end of the 90 days, in which case a shorter eligibility period until death will be permitted. Analyses for preterm delivery, macrosomia, small for gestational age, maternal hypoglycemia, polyhydramnios, preeclampsia, Cesarean delivery and induction of labor:
- Base cohort to include pregnancies drawn from the Truven database with linked offspring from 2014 onwards with pre-gestational type 2 diabetes.
- Maternal eligibility for Insurance from 90 days prior to the last menstrual period until 30 days post delivery.
- Offspring eligibility for at least 30 days after the delivery, unless the infant died prior to the end of the 30 days, in which case a shorter eligibility period will be permitted. Note, that infant eligibility is not necessarily required to study maternal outcomes, but to maintain consistency with the analysis of preterm, macrosomia and small for gestational age, we will require 30 days post-delivery eligibility for the infant (unless they died).
Exclusion criteria:
- Analysis for spontaneous abortions and stillbirths:
- Termination of pregnancy (since these pregnancies will not be at risk for other outcomes). Analysis for major congenital malformations:
- Pregnancies with a chromosomal abnormality based on at least one inpatient or outpatient ICD-9 code for 758.xx or 759.81-759.83 within the first 90 days of the date of birth in the infant and/or maternal claims.
- Pregnancies with outpatient exposure to definite teratogens including warfarin, antineoplastic agents, isotretinoin, misoprostol, and thalidomine from LMP through LMP plus 90 days (i.e., days of exposure overlap with 1st trimester).
- Pregnancies in which albiglutide is dispensed in the 3 months prior to the LMP but not during the first trimester (to insure that there is not misclassification of the non-exposed) Exclusion criteria for analyses for preterm delivery, macrosomia, small for gestational age, maternal hypoglycemia, polyhydramnios, preeclampsia, Cesarean delivery and induction of labor:
- Exclude pregnancies in which albiglutide is dispensed in the 90 days prior to the LMP but not during pregnancy itself.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Other
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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