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Artificial rupture of membrane versus induced of labor with misoprostol after failure of Foley catheter balloon cervical ripening in labor induction: a randomized trial

Artificial rupture of membrane versus induced of labor with misoprostol after failure of Foley catheter balloon cervical ripening in labor induction: a randomized trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067900
Enrollment
Unknown
Registered
2023-01-31
Start date
2023-01-31
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

labor induction of term pregnancy

Interventions

artificial rupture of membrane:artificial rupture of membrane
induced of labor with misoprostol:misoprostol 25 ug was placed vaginally for cervical ripening

Sponsors

Department of Obstetrics and Gynecology, Nanjing Drum Tower Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Term pregnancy, singleton head presentation, aged 18-40 years (not inclucing 18 and 40), and no contraindication for vaginal delivery; 2. Bishop score < 6 after Foley catheter balloon cervical induction; 3. Understanding and signing informed consent.

Exclusion criteria

Exclusion criteria: 1. Premature rupture of membranes, inflammation of the reproductive system, contraindication of balloon or misoprostol for ripening, carriage of group B Streptococcus, pelvic abnormalities; 2. History of previous uterine surgery; 3. Severe fetal malformations, fetal distress, Stillbirth, severe fetal growth restriction (estimated fetal weight < 3%),placental margin less than 6 cm from the cervix; 4. Asthma, glaucoma, allergy to prostaglandin preparations; 5. Use of other methods of cervical maturation; 6. Cognitive or intellectual disability.

Design outcomes

Primary

MeasureTime frame
Time from intervention to delivery;

Secondary

MeasureTime frame
Cesarean section indication;Cesarean section rate;Indications for operative vaginal birth;Operative vaginal birth rate;Time from intervention to vaginal delivery;time from intervention to active phase;rate of labor analgesia;rate of oxytocin using;Rate of vaginal delivery at 24 hours;Rate of vaginal delivery at 48 hours;

Countries

China

Contacts

Public ContactYimin Dai

Department of Obstetrics and Gynecology, Nanjing Drum Tower Hospital

nj_daiyimin@126.com+86 13851492169

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026