Comparing double-balloon catheter and Prostaglandin E2 for cervical ripening in low-risk pregnancies

The Effectiveness and Safety of Double-balloon Versus Vaginal Prostaglandin for Cervical Ripening in Women With Low-risk Pregnancies: A Randomized Controlled Trial (DOBA-PRO)

This study is testing whether a double-balloon catheter or a vaginal insert of Prostaglandin E2 works better and is safer for getting the cervix ready for labor in low-risk pregnant women who are close to their due date.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 540 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Hanoi Obstetrics and Gynecology Hospital (other)
• Locations: 1 site (Hanoi, Hà Nội)
• Trial ID: NCT04747301 on ClinicalTrials.gov

What this trial studies

This study aims to compare the effectiveness and safety of a double-balloon catheter versus vaginal insert Prostaglandin E2 for cervical ripening in low-risk pregnant women between 39 and 40 weeks of gestation. Induction of labor is necessary when the risks of continuing the pregnancy outweigh the risks of delivery, and cervical ripening is a crucial step if the cervix is not ready. The study will evaluate both mechanical and pharmacological methods of cervical ripening to determine which is more effective. The findings could provide valuable insights into optimizing labor induction practices for low-risk pregnancies.

Who should consider this trial

Good fit: Ideal candidates for this study are low-risk pregnant women aged 18 and older, with a singleton pregnancy, between 39 and 40 weeks of gestation, and an unfavorable cervix.

Not a fit: Patients with maternal medical illnesses, abnormal placental conditions, or fetal abnormalities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved methods for cervical ripening, enhancing the safety and effectiveness of labor induction for low-risk pregnancies.

How similar studies have performed: Previous studies have shown promising results for similar approaches, but this study aims to provide higher quality evidence in a low-risk population.

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

Where this trial is running

Hanoi, Hà Nội

• Hanoi Obstetrics and Gynecology Hospital — Hanoi, Hà Nội, Vietnam (RECRUITING)

Study contacts

• Principal investigator: Vinh Dang Quang, PhD. MD — Mỹ Đức Hospital
• Study coordinator: Ha Nguyen Thi Thu, PhD. MD

Conditions: Induction of Labor, Induction of labor, Low-risk pregnancies, Double-balloon catheter, Prostaglandin E2