Comparison of Vaginal Misoprostol Plus Supracervical Balloon Versus Vaginal Misoprostol Alone for Induction of Labor

Consorci Sanitari de Terrassa

Status and phase: Unknown; Phase 4

Conditions: Cervical Ripening; Induction of Labor; Pregnancy

Treatments: Drug: Misoprostol; Device: Foley catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT02762942

2015-002061-29 (EudraCT Number)

Details and patient eligibility

About

Demonstrate that with concomitant and synchronous use of supracervical balloon and vaginal misoprostol for induction of labour, vaginal delivery is achieved in less time compared with vaginal misoprostol alone.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

• Singleton pregnancy
• Cephalic presentation
• Reassuring fetal heart rate pattern
• Intact membranes
• Bishop score less than 6

Exclusion criteria

• Severe preeclampsia
• Prematurity ( < 37 weeks gestation dated by first trimester ultrasound)
• Previous cesarean section or previous uterine surgery
• Intrauterine growth restriction
• Premature rupture of membranes
• Maternal colonization with Streptococcus Agalactiae at any time during pregnancy
• Multifetal pregnancy
• Breech presentation
• Stillbirth
• Any contraindication for vaginal delivery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Vaginal misoprostol alone

Active Comparator group

Description:

Women in this group will receive 25mcg of vaginal misoprostol every 4 hours up to a maximum of 5 doses. Misoprostol will be stopped in case of a favorable cervix or if the patient is in active labor. In case of no progression after 5 doses of misoprostol, intravenous oxytocin will be perfused 4 hours after the last dose of misoprostol according to local protocols

Treatment:

Drug: Misoprostol

Vaginal misoprostol + Foley catheter

Experimental group

Description:

Women in this group will receive 25mcg of vaginal misoprostol every 4 hours up to a maximum of 5 doses. At the same time a 16French Foley catheter will be inserted through the internal os with visualization of the cervix by sterile speculum examination. The catheter balloon will be inflated with 30 ml of sterile normal saline solution and then the catheter will be taped with gentle traction to the inner thigh of the patient until spontaneous expulsion. If this does not occur, the catheter will be deflated and removed after 12 hours. Misoprostol will be stopped in case of a favorable cervix or if the patient is in active labor. In case of no progression after 5 doses of misoprostol, intravenous oxytocin will be perfused 4 hours after the last dose of misoprostol.

Treatment:

Device: Foley catheter

Drug: Misoprostol