The Feasibility Of Expectant Management Versus Induction At 38 Weeks Among Individuals With Gestational Diabetes Mellitus: A Randomized Controlled Pilot Trial (EAGER Pilot Trial)
A legfontosabb adatok
- Ki végzi
- Ottawa Hospital Research Institute
- Hol
- Kanada1 helyszín, 1 országbanVálassz országot a helyszínekhez
- Azonosító
- Állapot
- Toboroz
- Résztvevők
- 260 fő, tervezett
- Kezdés
- 2025. ápr. 7.
- Várható befejezés
- 2028. márc.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoportAz egyik csoport nem kap vizsgálati kezelést, összehasonlításként.
- A vizsgált kezelések
- Induction of Labour
- A regiszteradat frissítve
- 2025. november 18.
Ki vehet részt
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
The trial is looking for pregnant people with diabetes that started in pregnancy (gestational diabetes). It compares starting labour at 38 weeks with waiting for labour to start naturally.
- Életkor
- 16 years or older
- Nem
- Female
- A betegség stádiuma
- Gestational diabetes diagnosed after 24 weeks of pregnancy by standard tests. One live baby, head-down, at 36 weeks + 0 days to 38 weeks + 0 days of pregnancy. Must plan to give birth at a participating site.
- Korábbi kezelés
- People who had a Cesarean delivery before cannot join.
A részvétel fő kizáró okai
- Diabetes before the pregnancy
- High blood pressure, preeclampsia or other reasons for immediate delivery
- Signs of labour, broken waters or heavy vaginal bleeding at randomization
- Placenta problems (previa, accreta, vasa previa) or a stitch in the cervix (cerclage) in this pregnancy
- Known major problem in the baby, low fluid around the baby, or poor baby growth
Ez a vizsgálat csak várandós résztvevőket keres. A regiszter mondata, amelyen ez alapul: * 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.
A regiszter feltételei, szó szerint
Mind a 20 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- Prior Cesarean delivery
- Pre-pregnancy diabetes mellitus
- Significant vaginal bleeding or ruptured membranes at the time of randomization
- Known major fetal anomaly (e.g., gastroschisis, congenital heart defects)
- 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
- Placenta previa, placenta accreta, or vasa previa
- Cerclage in current pregnancy
- 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
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.
A vizsgálatról
Mit akar kideríteni a vizsgálat
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 consented between 32 weeks + 0 days and 38 weeks + 0 days gestation and randomized between 36 weeks + 0 days and 38 weeks + 0 days gestation. Participants will be randomized to one of two arms:
A teljes eredeti leírásKevesebb
* 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 may 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.
A vizsgálat 2 csoportja
- Induction of Labour between 38 weeks + 0 days and 38 weeks + 6 daysA vizsgált kezelés
Induction of Labour between 38+0 weeks and 38+6 weeks.
Kezelés: Induction of Labour
- Expectant ManagementNincs vizsgálati kezelés, összehasonlításként
Expectant management without intervention until spontaneous labour, or earlier at the discretion of the attending healthcare provider.
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- The Feasibility Of Expectant Management Versus Induction At 38 Weeks Among Individuals With Gestational Diabetes Mellitus: A Randomized Controlled Pilot Trial
- MI-összefoglaló
- A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 15.
- A regiszteradat frissítve
- 2025. november 18.