Status:
RECRUITING
DOuble-BAlloon Versus PROstaglandin E2 for Cervical Ripening in Low Risk Pregnancies
Lead Sponsor:
Hanoi Obstetrics and Gynecology Hospital
Collaborating Sponsors:
Mỹ Đức Hospital
Conditions:
Induction of Labor
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
To compare the effectiveness and safety of double balloon catheter and vaginal insert Prostaglandin E2 in cervical ripening prior to Induction of Labor in low-risk women from 39+0 to 40+6 weeks of ges...
Detailed Description
Induction of labor (IOL) is a technique to establish vaginal delivery when the risks for continuing the pregnancy for mother or baby are higher than the risks of delivery. In case the cervix is unripe...
Eligibility Criteria
Inclusion
- Maternal age ≥ 18
- Singleton pregnancy. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks gestational age.
- Gestational age at randomization from at 39+0 to 40+6 weeks of gestation.
- Cephalic presentation
- Intact membrane
- Unfavourable cervix (Bishop\<6)
- Informed consent
Exclusion
- 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.)
- Abnormal placenta: Active vaginal bleeding greater than bloody show or placenta previa, accreta or vasa previa
- Abnormal amniotic fluid volume:
- Oligohydramnios (MVP \< 2cm)
- Polyhydramnios (MVP \> 10cm)
- 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)
- Previous C-section
- Planned for C-section or contra-indication to labour
- Cerclage or use of pessary in current pregnancy
- Refusal of blood product.
- Participation in another interventional study that influences management of labour at delivery or perinatal morbidity or mortality
Key Trial Info
Start Date :
August 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT04747301
Start Date
August 1 2021
End Date
December 31 2025
Last Update
March 1 2024
Active Locations (1)
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1
Hanoi Obstetrics and Gynecology Hospital
Hanoi, Hanoi, Vietnam, 10000