Clinical trial comparing a pharmacological method for inducing labor with the combination of a pharmacological and a mechanical method.

Phase 1

• Conditions: Pegnant women with a term singleton pregnancy, cephalic presentation, reassuring fetal heart rate pattern, intact membranes and an unfavorable cervix (Bishop score less than 6), admitted to our institution for labour induction.; MedDRA version: 18.1Level: LLTClassification code 10055563Term: Labor inductionSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2015-002061-29-ES
• Lead Sponsor: Consorci Sanitari de Terrassa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-13
• Last Update Posted: 17 May 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Pegnant women with a term singleton pregnancy, cephalic presentation, reassuring fetal heart rate pattern, intact membranes and an unfavorable cervix (Bishop score less than 6), admitted to our institution for labour induction.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1- Exclusion criteria pre-randomization:
- Patient refusal to participate in the trial
- Misoprostol contraindication acording to the misoprostol leaflet:
- Severe Preeclampsia
- Prematurity (<37 weeks gestation dated by first trimester ultrasound)
- Previous cesarean section or previous uterine surgery
- Intrauterine growth restriction
- Whenever placement of supracervical balloon might lead to an increase in the risk of infections and chorioamnionitis:
- Premature rupture of membranes
- Maternal colonization with Streptococcus agalactiae at any time during the pregnancy
- Other infrequent situations that may act as a confounder factor:
- Multifetal gestation
- Breech presentation
- Stillbirth

2- Exclusion criteria postrandomization
- Maternal leaving of the study during induction
- Adverse effects secondary to the supracervical balloon, such as pain or maternal discomfort

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: 1- To assess cervical ripening and labour progression.<br>2- To assess the requirement and dosage of drugs for cervical ripening and labour induction.<br>3- To assess the requirement of analgesia in labour.<br>4- To assess adverse effects during labour and perinatal outcomes.<br>5- To evaluate the route and type of delivery.;Primary end point(s): Induction to delivery time with the concomitant use of misoprostol and supracervical balloon compared with misoprostol alone.;Timepoint(s) of evaluation of this end point: Once successful delivery.