Skip to content

The establishment of clinical protocol for the induction of labour with double-balloon catheter and intravaginal misoprostol in gestational diabetes mellitus

Comparison of the effects of double-balloon catheter and intravaginal misoprostol for the induction of labour in gestational diabetes mellitus

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032216
Enrollment
Unknown
Registered
2020-04-23
Start date
2020-06-01
Completion date
Unknown
Last updated
2020-11-24

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

Conditions

Gestational diabetes mellitus

Interventions

Balloon Group:Place cervical balloon
Misoprostol group:Place misoprostol

Sponsors

Shenzhen Baoan District Maternal and Child Health Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. The pregnant women in the balloon group and miso group met the diagnostic criteria of gestational diabetes; 2. There was no prom in both groups and the gestational age was >= 40 weeks; 3. Pregnant women who have regular birth examination, hospital delivery and complete clinical data in our hospital; 4. Pregnant women with single head position; 5. Pregnant women with bishop cervical score less than 6.

Exclusion criteria

Exclusion criteria: 1. Fetal death; 2. Poor blood sugar control, or use insulin to control blood sugar during pregnancy; 3. Examination of vaginal secretions before placing the balloon: vaginal cleanliness >= III degree, or visible fungal spores (GV) or trichomonas (Tri); 4. Bacterial vaginosis sialidase (BV) positive (+); 5. There are special high-risk complications in pregnancy (such as fetal distress, oligohydramnios, hypertensive disorder complicating pregnancy, etc.); 6. Placenta praevia and vasa praevia; 7. Severe comorbidities and complications, such as severe abnormal functions of heart, kidney and liver, can not tolerate vaginal delivery; 8. History of cesarean section or uterine surgery ; 9. Obvious cephalopelvic disproportion; 10. Cervical cancer; 11. Certain infectious diseases of the genital tract, such as the active phase of herpes infection; 12. Untreated acquired immunodeficiency virus infection; 13. People with heart disease, acute liver and kidney disease, severe anemia, glaucoma, asthma, epilepsy; 14. People who are allergic to induced drugs; 15. History of precipitate labour; 16. The number of deliveries > 3.

Design outcomes

Primary

MeasureTime frame
vaginal birth within 24h;

Secondary

MeasureTime frame
fetal stress;

Countries

China

Contacts

Public ContactJiahui Jie

Shenzhen Baoan District Maternal and Child Health Hospital

493661057@qq.com+86 15811705349

Outcome results

None listed

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