Normal risk nulliparous women who have no pregnancy-related or medical contraindication to Induction of Labour MedDRA version: 20.0 Level: LLT Classification code 10055563 Term: Labor induction System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Propess
Pharmaceutical Form: Vaginal delivery system
Sponsors
The Rotunda Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Normal risk nulliparous women (as defined in trial objectives) • Age =18 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Multiparous women • Women with uterine scar • Women with low lying placenta • Women with BMI > 35kg/m2 • Multiple gestation • Known fetal anomaly or fetal growth restriction or oligohydramnios • Known maternal health problem e.g. Hypertensive disease, cardiac disease, renal disease, diabetes, pulmonary disease, hepatic disease which would directly affect the risk status of the woman. This is assessed clinically on a case by case basis. • Women with no transport to hospital or women who live >30 mins or >15km from the hospital • Patients who have difficulty understanding the required protocol and follow up instructions (e.g. language barriers) • Women <39+0 or greater than 39+4 weeks’ gestation at the time of induction of labour (Visit 2) -Gestational age will be based on initial dating scan between 7-14 weeks, which confirms gestational age by CRL. • Any factor which is a contraindication to induction of labour • Contraindications to trial treatment include patients that fall into any of the following categories: o If labour has started. o If oxytocic drugs and/or other labour induction agents have been given. o When strong prolonged uterine contractions would be inappropriate o Patients who have had previous major uterine surgery, e.g. Caesarean section, myomectomy o Patients with a clinical suspicion for cephalopelvic disproportion o Patients with fetal malpresentation o Patients with suspicion or evidence of non-reassuring fetal testing o Who have had previous major surgery (e.g. Other than biopsies and cervical abrasion) or rupture of the uterine cervix o When there is current pelvic inflammatory disease, unless adequate prior treatment has been instituted. o Patients with hypersensitivity to dinoprostone or to any of the excipients listed in the SmPC for Propess/Prostin o Patients with placenta previa or unexplained vaginal bleeding during the current pregnancy. o Patients with evidence or any sign of infection, including genital tract infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate non-inferiority in the efficacy of Dilapan-S® (12 hours or 24 hours insertion) to Propess for outpatient induction of labour at 39 weeks’ gestation in otherwise uncomplicated, normal risk* nulliparous women. the following conditions should be met to consider a pregnancy to be normal risk Singleton pregnancy Cephalic presentation Term gestation (37-39 weeks gestational age) Maternal pre-pregnancy body mass index < 35kg/m2 Maternal age of = 18 and < 40 years No evidence of the following conditions: Pre-pregnancy diabetes Gestational diabetes Pre-pregnancy hypertension Cervical cerclage in situ Premature rupture of membranes Congenital fetal anomalies;Secondary Objective: 1)To compare the Dilapan-S® (12 hours) group to the Propess group in the primary endpoint and secondary endpoints (see Section 10.3 for further details) 2)To compare the the Dilapan-S® (24 hours ) group to the Propess group in the primary endpoint and secondary endpoints (see Section 10.3 for further details) 3)To compare the Dilapan-S® (12 hours) group to the Dilapan-S® (24 hours ) group in the primary endpoint and secondary endpoints (see Section 10.3 for further details) 4)To compare rates of vaginal delivery in the Dilapan-S® 12-hour group, the Dilapan-S® 24-hour group and the Propess at 36 hours, 48 hours and 48 hours respectively from insertion time to delivery (see Section 10.3 for further details) ;Primary end point(s): The primary outcome measure (efficacy measure) is failure to achieve vaginal delivery (or, equivalently, operative vaginal delivery or SVD) at any time. This will allow assessment of effective methods of IOL in the outpatient setting. The window for induction will be 39+0 to 39+4 weeks gestation.;Timepoint(s) of evaluation of this end point: 39+0 to 39+4 weeks gestation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Overall change in Bishop score before and after cervical ripening 2. Rates of vaginal delivery at 36 hours after insertion of either Propess or Dilapan-S® 3. Rates of vaginal delivery at 48 hours after insertion of either Propess or Dilapan-S® 4. The need for second induction modality 5. Rates of hyper-stimulation* 6. Rate of failed induction 7. Overall length of stay in hospital 8. Rates of adverse neonatal outcome 9. Rates of adverse maternal outcomes 10. Maternal satisfaction scores with the outpatient induction process 11. Caesarean delivery rates, categorized by “overall rate”, “rate for failure to progress/failed induction”, and “rate for non-reassuring fetal testing” 12. Analgesia use in each group, including rates of epidural 13. Compare rates of 39 weeks’ successful vaginal delivery in the outpatient setting to rates of successful vaginal delivery in the inpatient setting**. *defined as more than 7 contractions in a 15 minute time period persistently for more than 30 minutes and requiring a medical intervention (such as a clinical decision to remove the Propess/Dilapan or administer a medication such as Terbutaline). **defined as a group of low risk nulliparous women who did not undertake elective induction of labour at 39 weeks as part of this trial. ;Timepoint(s) of evaluation of this end point: 39+0 weeks gestation to 6 weeks postpartum (+/- days) | — |
Countries
Ireland
Contacts
Public ContactMandy Jackson
Royal College of Surgeons Ireland
Outcome results
None listed