Efficacy and safety of hourly titrated misoprostol versus vaginal dinoprostone and misoprostol for and labor induction: randomized clinical trial.

Efficacy and safety of hourly titrated misoprostol versus vaginal dinoprostone and misoprostol for cervical ripening and labor induction: randomized clinical trial. - DV-MV-MO

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003412-20-ES

Enrollment

Unknown

Registered

2016-01-13

Start date

2016-08-01

Completion date

Unknown

Last updated

2016-08-29

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

Conditions

labor induction

Interventions

Trade Name: Misofar Pharmaceutical Form: Vaginal tablet INN or Proposed INN: Misoprostol CAS Number: 59122-46-2 Current Sponsor code: Misoprostol Other descriptive name: MISOPROSTOL Concentration unit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Women over 18 ? single pregnancy ? cephalic presentation ? intact membranes ? unfavorable cervix ( less than 6 Bishop ) ? CTGR not reactive decelerative ? Signed informed consent by the patient. 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 372 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: ? prior Cesarean section or previous uterine surgery . ? Allergy or intolerance to any of the study drugs ? stillbirth ? uterine growth restricted fetuses ? contraindication for vaginal delivery ? Anterior placenta ? Multiparity ? moderate to severe heart disease ? hypertensive disorders of pregnancy ? Suspected chorioamnionitis

Design outcomes

Primary

Measure	Time frame
Main Objective: Compare the percentage of women in each group who achieved vaginal delivery within 24 hours after the beginning of the administration in each group (oral misoprostol, vaginal misoprostol and intravaginal dinoprostone).;Secondary Objective: -Determinate the number of women who manage cervical favorable conditions at 12 and 24 hours after the beginning of the administration -Analyze the percentage of women in each group who achieve vaginal delivery at 12 and 24 hours after the beginning of the administration in each group. -Compare the number of women who achieve a vaginal delivery -Analyze the number of caesarean sections -Compare the percentage of women requiring oxytocin and mg -Compare labor duration of in the 3 groups the length of the latent and active phase -Compare the percentage of failed induction -Determinate the percentage of women in each group having tachysystole and/or uterine hypertnya -Compare the percentage of women who suffered from -severe postpartum hemorrhage -Analyze the values of pH and Apgar at minute 1 and 5 on all children born alive Compare the percentage of children with neonatal complications. -Compare fetal or neonatal mortality Estimate neonatal morbidity;Primary end point(s): Vaginal delivery within 24 hours after the begining of administration.;Timepoint(s) of evaluation of this end point: 24 hours	—

Measure

Time frame

Main Objective: Compare the percentage of women in each group who achieved vaginal delivery within 24 hours after the beginning of the administration in each group (oral misoprostol, vaginal misoprostol and intravaginal dinoprostone).;Secondary Objective: -Determinate the number of women who manage cervical favorable conditions at 12 and 24 hours after the beginning of the administration -Analyze the percentage of women in each group who achieve vaginal delivery at 12 and 24 hours after the beginning of the administration in each group. -Compare the number of women who achieve a vaginal delivery -Analyze the number of caesarean sections -Compare the percentage of women requiring oxytocin and mg -Compare labor duration of in the 3 groups the length of the latent and active phase -Compare the percentage of failed induction -Determinate the percentage of women in each group having tachysystole and/or uterine hypertnya -Compare the percentage of women who suffered from -severe postpartum hemorrhage -Analyze the values of pH and Apgar at minute 1 and 5 on all children born alive Compare the percentage of children with neonatal complications. -Compare fetal or neonatal mortality Estimate neonatal morbidity;Primary end point(s): Vaginal delivery within 24 hours after the begining of administration.;Timepoint(s) of evaluation of this end point: 24 hours

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Secondary

Measure	Time frame
Secondary end point(s): -Favorable cervix: This criterion is determined at 12 and 24 hours after initiation of drug administration . It is considered a favorable cervix should submit a Bishop equal to or greater than 6 .-This criterion is determined at 12 and 48 hours after the begining of drug administration. -vaginal delivery: Eutocic and instrumental labor will be taken into account. - number of cesarean sections -oxitocin administration and dose(mg) -labor duration (hour) -active and latent phases duration (hours) -Induction failure: Induction failure will be considered in case of incapacity of the patient into active labor after oxytocin for 12 ± 3 hours after the rupture of membranes. -Taquisistolia:It will be considered when uterine activity occurs with 6 or more contractions in 10 min for at least 30 minutes. -Hipertonía: It will be considered when uterine contraction maintained longer than 2 minutes produced complete relaxation occurs . - Severe postpartum hemorrhage: All those postpartum hemorrhage requiring blood transfusion , positioning of intrauterine balloon , carrying uterine compression suture (B- Lynch) , radiological embolization , performing vascular ligatures, hysterectomy, ICU admission or death -pH value and Apgar (1 and 5 minutes) -neonatal morbidity: For the purposes of this study are considered fetal morbidity Apgar at 5 minutes less than 4, neonatal trauma , seizuresi in the first 24 hours of life, tracheal ventilation over 24 hours and / or hospitalization in neonatal unit of length equal to or greater than 5 days.;Timepoint(s) of evaluation of this end point: between 12 hours and 3 days	—

Measure

Time frame

Secondary end point(s): -Favorable cervix: This criterion is determined at 12 and 24 hours after initiation of drug administration . It is considered a favorable cervix should submit a Bishop equal to or greater than 6 .-This criterion is determined at 12 and 48 hours after the begining of drug administration. -vaginal delivery: Eutocic and instrumental labor will be taken into account. - number of cesarean sections -oxitocin administration and dose(mg) -labor duration (hour) -active and latent phases duration (hours) -Induction failure: Induction failure will be considered in case of incapacity of the patient into active labor after oxytocin for 12 ± 3 hours after the rupture of membranes. -Taquisistolia:It will be considered when uterine activity occurs with 6 or more contractions in 10 min for at least 30 minutes. -Hipertonía: It will be considered when uterine contraction maintained longer than 2 minutes produced complete relaxation occurs . - Severe postpartum hemorrhage: All those postpartum hemorrhage requiring blood transfusion , positioning of intrauterine balloon , carrying uterine compression suture (B- Lynch) , radiological embolization , performing vascular ligatures, hysterectomy, ICU admission or death -pH value and Apgar (1 and 5 minutes) -neonatal morbidity: For the purposes of this study are considered fetal morbidity Apgar at 5 minutes less than 4, neonatal trauma , seizuresi in the first 24 hours of life, tracheal ventilation over 24 hours and / or hospitalization in neonatal unit of length equal to or greater than 5 days.;Timepoint(s) of evaluation of this end point: between 12 hours and 3 days

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Countries

Spain

Contacts

Public ContactOihane Lapuente Ocamica

Basque Health System

OIHANE.LAPUENTEOCAMICA@osakidetza.eus34945007204

Outcome results

None listed

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