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

Prospective randomized clinical trial comparing the effect of vaginal misoprostol synchronously with supracervical ball, versus only vaginal misoprostol for induction of labor.

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002061-29-ES

Enrollment

Unknown

Registered

2016-01-13

Start date

2016-03-21

Completion date

Unknown

Last updated

2016-05-17

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

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: 18.1 Level: LLT Classification code 10055563 Term: Labor induction System Organ Class: 100000004865

Interventions

Trade Name: Misofar 25 microgramos comprimidos vaginales Pharmaceutical Form: Vaginal tablet INN or Proposed INN: MISOPROSTOL CAS Number: 59122-46-2 Current Sponsor code: C22H38O5 Other descriptive na

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. 2- To assess the requirement and dosage of drugs for cervical ripening and labour induction. 3- To assess the requirement of analgesia in labour. 4- To assess adverse effects during labour and perinatal outcomes. 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.	—

Measure

Time frame

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. 2- To assess the requirement and dosage of drugs for cervical ripening and labour induction. 3- To assess the requirement of analgesia in labour. 4- To assess adverse effects during labour and perinatal outcomes. 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.

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Secondary

Measure	Time frame
Secondary end point(s): - Bishop score at 12 hours from the onset of induction - Bishop score at 24 hours from the onset of induction - Number of doses of misoprostol required - Percentage of pregnant women requiring oxytocin - Maximum dosage of oxytocin given (mU / min) - Percentage of pregnant women requiring epidural analgesia - Percentage of pregnant women with tachysystole and / or hypertone with absence of fetal heart rate decelerations - Percentage of pregnant women with tachysystole and / or hypertone with fetal heart rate decelerations - Percentage of pregnant women with intrapartum fever - Percentage of pregnant women with maternal side effects - Percetage of pregnant women with vaginal delivery within 12 hours from the onset of induction - Percentage of pregnant women with vaginal delivery within 24 hours from the onset of induction - Total rate of cesarean section - Percentage of cesarean sections for failed induction - Percentage of cesarean sections for nonreassuring fetal status - Neonatal intesive care unit admission - Apgar score at 5 minutes - Umbilical artery pH;Timepoint(s) of evaluation of this end point: Once successful delivery.	—

Measure

Time frame

Secondary end point(s): - Bishop score at 12 hours from the onset of induction - Bishop score at 24 hours from the onset of induction - Number of doses of misoprostol required - Percentage of pregnant women requiring oxytocin - Maximum dosage of oxytocin given (mU / min) - Percentage of pregnant women requiring epidural analgesia - Percentage of pregnant women with tachysystole and / or hypertone with absence of fetal heart rate decelerations - Percentage of pregnant women with tachysystole and / or hypertone with fetal heart rate decelerations - Percentage of pregnant women with intrapartum fever - Percentage of pregnant women with maternal side effects - Percetage of pregnant women with vaginal delivery within 12 hours from the onset of induction - Percentage of pregnant women with vaginal delivery within 24 hours from the onset of induction - Total rate of cesarean section - Percentage of cesarean sections for failed induction - Percentage of cesarean sections for nonreassuring fetal status - Neonatal intesive care unit admission - Apgar score at 5 minutes - Umbilical artery pH;Timepoint(s) of evaluation of this end point: Once successful delivery.

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Countries

Spain

Contacts

Public ContactHospital de Terrassa

Consorci Sanitari de Terrassa

MAVives@cst.cat00349373100077098

Outcome results

None listed

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