Is there an interest in repeating the vaginal administration of dinoprostone ( Propess® ) , to promote cervical ripening of pregnant women at term?

Is there an interest in repeating the vaginal administration of dinoprostone ( Propess® ) , to promote cervical ripening of pregnant women at term? - RE-DINO

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000147-13-FR

Enrollment

360

Registered

2016-04-22

Start date

2016-06-21

Completion date

Unknown

Last updated

2022-05-23

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

Conditions

cervix ripening MedDRA version: 19.0 Level: PT Classification code 10073175 Term: Induction of cervix ripening System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Propess Pharmaceutical Form: Vaginal delivery system INN or Proposed INN: DINOPROSTONE Other descriptive name: DINOPROSTONE Concentration unit: mg milligram(s) Concentration type: equal Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age = 18 years. - Term pregnancy> 37 weeks - Current Trigger medically indicated - Patients who have had the establishment of a first Propess®, within 24 to 36 hours (before signing the consent) - Cephalic presentation - Unfavorable cervical conditions (Bishop score =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Multiple pregnancy - Uterus scar - Contraindications to epidural anesthesia - Contraindications to Propess®: recent history of pelvic inflammatory disease; hypersensitivity to prostaglandins - Contraindications to Syntocinon: Hypersensitivity to oxytocin, cardiovascular disorders and severe toxemia of pregnancy. - Contraindications to vaginal delivery - Premature Rupture of Membranes (PROM) - Intra Uterine Growth retardation (IUGR) 97th percentile - Impaired fetal heart rate - Fetal Death In Utéro (IUFD) - Patient under guardianship, curatorship or safeguard justice

Design outcomes

Primary

Measure	Time frame
Main Objective: Demonstrate, if cervical ripening failure by a first Propess®, the laying of a second Propess® (followed if necessary by oxytocin (Syntocinon®)) increases the rate of births vaginally by compared to the direct injection of oxytocin (Syntocinon®).;Secondary Objective: 1. Comparison of the proportion trigger failure 2. Assessment and comparison of maternal morbidity and mortality 3. Assessment and comparison of fetal morbidity and mortality;Primary end point(s): The rate of vaginal deliveries.;Timepoint(s) of evaluation of this end point: At the delivery	—

Measure

Time frame

Main Objective: Demonstrate, if cervical ripening failure by a first Propess®, the laying of a second Propess® (followed if necessary by oxytocin (Syntocinon®)) increases the rate of births vaginally by compared to the direct injection of oxytocin (Syntocinon®).;Secondary Objective: 1. Comparison of the proportion trigger failure 2. Assessment and comparison of maternal morbidity and mortality 3. Assessment and comparison of fetal morbidity and mortality;Primary end point(s): The rate of vaginal deliveries.;Timepoint(s) of evaluation of this end point: At the delivery

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Secondary

Measure	Time frame
Secondary end point(s): 1. The triggering of failure The failure of the trigger is the lack of work setting: remaining cervical dilation <3cm despite 8am Syntocinon (or 1 syringe) and lack of regular uterine contractions and amniotomy. The success of the trigger is defined by regular uterine contractions and cervical dilatation = 3 cm. 2. Criteria of maternal morbidity and mortality: - Duration of work: time in minutes between the start of work defined by the onset of regular uterine contractions and cervical dilatation of =3 cm and childbirth. - Caesarean indications - Proportion of instrumental delivery - Proportion of complications of delivery and the various supported. - Proportion of uterine rupture - The transfer to intensive care - Duration of hospital stay of the mother - maternal death 3. Criteria fetal morbidity and mortality: - Apgar score at 3, 5 and 10 min - Assessment of fetal acidosis umbilical arterial pH and lactate - The presence of amniotic fluid meconium - The share transfer in neonatology or neonatal resuscitation - Fetal / neonatal death;Timepoint(s) of evaluation of this end point: 1. 24h 2. At the end of hospitalisation 3. After delivery	—

Measure

Time frame

Secondary end point(s): 1. The triggering of failure The failure of the trigger is the lack of work setting: remaining cervical dilation <3cm despite 8am Syntocinon (or 1 syringe) and lack of regular uterine contractions and amniotomy. The success of the trigger is defined by regular uterine contractions and cervical dilatation = 3 cm. 2. Criteria of maternal morbidity and mortality: - Duration of work: time in minutes between the start of work defined by the onset of regular uterine contractions and cervical dilatation of =3 cm and childbirth. - Caesarean indications - Proportion of instrumental delivery - Proportion of complications of delivery and the various supported. - Proportion of uterine rupture - The transfer to intensive care - Duration of hospital stay of the mother - maternal death 3. Criteria fetal morbidity and mortality: - Apgar score at 3, 5 and 10 min - Assessment of fetal acidosis umbilical arterial pH and lactate - The presence of amniotic fluid meconium - The share transfer in neonatology or neonatal resuscitation - Fetal / neonatal death;Timepoint(s) of evaluation of this end point: 1. 24h 2. At the end of hospitalisation 3. After delivery

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Countries

France

Contacts

Public ContactDirection Research and Innovation

CHU de LIMOGES

drc@chu-limoges.fr+33555056349

Outcome results

None listed

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