Clinical trial NCT06641141: The Feasibility Of Expectant Management Versus Induction At 38 Weeks Among Individuals With Gestational Diabetes Mellitus: A Randomized Controlled Pilot Trial
Official title: The Feasibility Of Expectant Management Versus Induction At 38 Weeks Among Individuals With Gestational Diabetes Mellitus: A Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gestational Diabetes Mellitus (GDM)
Keywords: gestational diabetes mellitus
gestational diabetes
induction
induction of labour
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 260
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a multi-centre Prospective Randomized Open-label Blinded Endpoint (PROBE) Pilot Trial
Primary purpose: OTHER

Brief summary: The EAGER pilot trial is designed to assess the feasibility of a Canadian, multicentre prospective randomized open-label blinded end-point (PROBE) clinical trial addressing whether induction of labour (IOL) at 38 weeks' gestation compared to expectant management (EM) reduces severe perinatal mortality and morbidity among individuals with gestational diabetes mellitus (GDM). Eligible participants will be recruited between 36 weeks + 0 days and 38 weeks + 0 days gestation. Participants will be randomized to one of two arms:

* Intervention Arm: IOL between 38 weeks + 0 days and 38 weeks + 6 days OR
* Control Arm: EM without intervention until spontaneous labour, or earlier if a medical indication arises.

A total of 260 participants (130 per group) will be recruited from Canadian sites, where participants will have 3 study visits:

1. Enrollment and randomization
2. After delivery and up to 72 hours postpartum
3. 6 weeks postpartum At enrollment and randomization, patient-reported baseline and clinical data from medical charts will be collected. Upon admission to hospital for labour and delivery, a blood sample will be collected to assess HbA1C and plasma glucose levels. After delivery and up to 72 hours postpartum, study feasibility will be assessed through patient-reported outcomes and administrative and clinical data. At 6 weeks postpartum, participants will be surveyed for secondary health resource use. Findings from this pilot will inform the design, implementation and feasibility of a future full-scale randomized controlled trial.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of GDM after 24 weeks of gestation, based on documented 1-step or 2-step screening and diagnostic tests for GDM.
* Singleton fetus at randomization.
* Confirmed live fetus within 24 hours prior to randomization.
* Gestational age between 36 weeks + 0 days and 38 weeks + 0 days inclusive based on an ultrasound in the first or second trimester \[≤ 23 weeks + 0 days\]. For pregnancies conceived by in vitro fertilization, dating will be based on the embryo age at transfer.
* Cephalic presentation.
* Planning to deliver at a participating site.
* Aged 16 years or older.

Exclusion Criteria:

* Pre-pregnancy diabetes mellitus.
* Any obstetrical/maternal indication for immediate delivery including placenta abruption, abnormal fetal well-being either by non-stress test or biophysical profile, history of venous thromboembolism (VTE) on low molecular weight heparin, pre-existing hypertension, gestational hypertension, preeclampsia, eclampsia, or Hemolysis, elevated liver enzymes and low platelets (HELLP) syndrome at the time of randomization.
* Contraindication to labour and/or vaginal delivery.
* Signs of labour (regular uterine contractions accompanied by cervical dilation and/or effacement) at the time of randomization.
* Significant vaginal bleeding or ruptured membranes at the time of randomization.
* Prior Cesarean delivery.
* Placenta previa, placenta accreta, or vasa previa.
* Cerclage in current pregnancy.
* Known major fetal anomaly (e.g., gastroschisis, congenital heart defects).
* Known oligohydramnios (AFI \< 5 or MVP \< 2 or no 2 by 2 pocket).
* Known fetal growth restriction (EFW \< 3rd percentile).
* Refusal of blood products.
* Use of unregulated substances.

Primary outcomes:
measure: Participant Recruitment Rate
timeFrame: Within 12 months of randomizing the first participant
Secondary outcomes:
measure: Appropriateness of eligibility criteria
timeFrame: Within 12 months of randomizing the first participant
measure: Participant retention
timeFrame: Within 12 months of randomizing the first participant
measure: Non-compliance
timeFrame: Within 12 months of randomizing the first participant
measure: Participant satisfaction
timeFrame: Within 12 months of randomizing the first participant
measure: Suitability of maternal and neonatal clinical endpoints.
timeFrame: Within 12 months of randomizing the first participant
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Mark C Walker, MD, MSc, MHM
role: PRINCIPAL_INVESTIGATOR
affiliation: Ottawa Hospital Research Institute
name: Darine El-Chaâr, MD, FRCS(C), MSc
role: PRINCIPAL_INVESTIGATOR
References: