COMPLETED

CAPO: Continuous Glucose Monitoring in A2 Gestational Diabetes and Pregnancy Outcomes

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will utilize continuous glucose monitoring in women with A2 gestational diabetes. Women will be randomized to continuous glucose monitoring or routine care with fingersticks to check their blood glucose four times daily. It is hypothesized that women in the continuous glucose monitoring arm will have a lower incidence of the composite primary outcome, which includes the following variables: perinatal death, shoulder dystocia, birth weight greater than 4,000 grams, NICU admission for treatment of hypoglycemia (blood glucose level \<40mg/dL) and birth trauma, including fracture or nerve palsy.

Official Title

CAPO: Continuous Glucose Monitoring in A2 Gestational Diabetes and Pregnancy Outcomes

Quick Facts

Study Start:2020-09-01
Study Completion:2024-08-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04219085

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * women between 18-50 years old
  2. * pregnant
  3. * singleton gestation
  4. * diagnosis of gestational diabetes requiring medication (A2) during the current pregnancy between 24-36 weeks' gestation
  1. * pregestational diabetes
  2. * diagnosis with gestational diabetes \< 24 weeks gestation or \> 36 weeks gestation
  3. * known fetal anomalies
  4. * fetal growth restriction diagnosed during the current pregnancy
  5. * diagnosis of polyhydramnios at time of randomization
  6. * abnormal diagnostic genetic testing or genetic screening for the fetus in the current pregnancy prior to randomization
  7. * twin or higher order multiple gestation
  8. * non-compliance with prenatal visits (missing ≥3 visits prior to enrollment) prior to diagnosis with A2 gestational diabetes
  9. * maternal medical comorbidities including the following: lupus, chronic hypertension, cancer, ischemic cardiovascular disease

Contacts and Locations

Principal Investigator

Audrey Merriam, MD, MS
PRINCIPAL_INVESTIGATOR
Assistant Professor; Assistant Professor, Department of Obstetrics, Gynecology and Reproductive Sciences

Study Locations (Sites)

Yale University
New Haven, Connecticut, 06511
United States

Collaborators and Investigators

Sponsor: Yale University

  • Audrey Merriam, MD, MS, PRINCIPAL_INVESTIGATOR, Assistant Professor; Assistant Professor, Department of Obstetrics, Gynecology and Reproductive Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-01
Study Completion Date2024-08-30

Study Record Updates

Study Start Date2020-09-01
Study Completion Date2024-08-30

Terms related to this study

Keywords Provided by Researchers

  • gestational diabetes
  • fetal or neonatal outcomes
  • maternal morbidity

Additional Relevant MeSH Terms

  • Gestational Diabetes
  • Maternal Complication of Pregnancy