DOuble-BAlloon Versus PROstaglandin E2 for Cervical Ripening in Low Risk Pregnancies

Launched by HANOI OBSTETRICS AND GYNECOLOGY HOSPITAL · Feb 5, 2021

Keywords

ClinConnect Summary

This clinical trial, titled "DOuble-BAlloon Versus PROstaglandin E2 for Cervical Ripening in Low Risk Pregnancies," is designed to compare two methods for preparing the cervix for labor in low-risk pregnant women. The study will look at how effective and safe a double balloon catheter is compared to a vaginal insert called Prostaglandin E2. Participants must be women aged 18 or older, be at least 39 weeks pregnant, have a single baby in a head-down position, and have not yet begun labor.

If you join this study, you will be randomly assigned to receive either the double balloon catheter or the Prostaglandin E2 insert to help prepare your cervix for labor. It’s important to know that certain health issues or complications, such as diabetes or previous surgeries, might make you ineligible for this trial. The research is currently open for enrollment, and participants will be monitored closely to ensure their safety and well-being throughout the process.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Maternal age ≥ 18
• • 2. Singleton pregnancy. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks gestational age.
• • 3. Gestational age at randomization from at 39+0 to 40+6 weeks of gestation.
• • 4. Cephalic presentation
• • 5. Intact membrane
• • 6. Unfavourable cervix (Bishop\<6)
• • 7. Informed consent
• Exclusion Criteria:
• • 1. Maternal medical illness associated with increased risk of adverse pregnancy outcome (any diabetes mellitus, any hypertensive disorders, cardiac diseases, renal insufficiency, systemic lupus erythematosus, mental disorders, HIV positive, use of heparin or low-molecular weight heparin during the current pregnancy etc.)
• • 2. Abnormal placenta: Active vaginal bleeding greater than bloody show or placenta previa, accreta or vasa previa
• 3. Abnormal amniotic fluid volume:
• • Oligohydramnios (MVP \< 2cm)
• • Polyhydramnios (MVP \> 10cm)
• • 4. Abnormal fetus
• • Fetal demise or known major fetal anomalies
• • Fetal growth restriction (FGR) (EFW \< 3% or \< 10% and abnormal Doppler)
• • Non-reassuring fetal status (no fetal movements, abnormal fetal heart rate at auscultation)
• • 5. Previous C-section
• • 6. Planned for C-section or contra-indication to labour
• • 7. Cerclage or use of pessary in current pregnancy
• • 8. Refusal of blood product.
• • 9. Participation in another interventional study that influences management of labour at delivery or perinatal morbidity or mortality