Delivery Uterine
Conditions
Keywords
Induction of labor, cervical ripening, misoprostol,, prostaglandin, cost-effectiveness
Brief summary
For about 10% of pregnancies, it is necessary to induce delivery for medical reasons. Prostaglandins alone can be used to perform cervical ripening in cases of immature cervix. In France, dinoprostone is the own approved medication. It is in the form of gel or sustained release device whose effectiveness and side effects are comparable. The vaginal misoprostol has no marketing authorization in France, but is sometimes used. Some data in the scientific literature have showed that its use with low-dose (25 mcg) vaginally did not lead to more complications, was at least as effective and seems to be cost-effective compared with dinoprostone. Misoprostol with this dose and route of administration is now recommended by the American College of Obstetricians and Gynecologist (ACOG), Grade A (ACOG Practice Bulletin August 2009). This is not the case in France (French HAS 2008 Guidelines on induction of labor). According to HAS, the investigators still lack data on large samples to confirm the benefits of misoprostol 25 mcg vaginally, in terms of efficiency, rate of cesarean section, and lower cost compared to dinoprostone. The primary objective is to demonstrate non-inferiority of vaginal misoprostol 25 mcg vs. dinoprostone in terms of cesarian section occurence with a non-inferiority margin of +5% difference.
Detailed description
To show if the experimental treatment (25μg of intravaginal misoprostol) used for induction of labor in singleton women ≥ 36 weeks gestation with an unfavorable cervix is not clinically and statistically inferior than the reference treatment , ie intravaginal dinoprostone sustained release (10mg), in terms of cesarian sectionto compare the cost-effectiveness and to assess the differential tolerance of the two strategies. Non-inferiority will be demonstrated if the upper limit of the 90%-bilateral confidence interval of the difference between cesarian section rates (misoprostol - dinosprostone) is below 5% in the intention-to-treat analysis and the per-protocol analysis. If non-inferiority is demonstrated, as a secondary analysis, superiority of misosprostol will be tested. Orther secondary objectives are to assess the cost-effectiveness, the tolerance, maternal satisfaction and other efficacy endpoints of the two strategies.
Interventions
DRUGMisoprostol
administration of Misoprostol 25 micrograms capsule by intravaginal route every 4 hours, up to 4 capsules
DRUGDinoprostone
administration of one sustained released pessary of 10 milligrams by intravaginal route
Sponsors
University Hospital, Toulouse
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* singleton pregnancy * Cephalic presentation * Bishop ≤ 5 * ≤ 3 uterine contractions / 10 mn * ≥ 36 weeks gestation * Personally signed and dated informed consent document
Exclusion criteria
* History of cesarian-section * uterine scar * deceleration on Cardiotocogram (CTG) * placenta praevia * bleeding * chorioamnionitis * Fetal weight US ≥4500 g * Contra-indication to vaginal delivery * Hystory of myomectomy * Herpes primoinfection or recurrence * Allergy to prostaglandins
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cesarean for all indications | Up to delivery | Occurrence of cesarean section for all indications |
Secondary
| Measure | Time frame |
|---|---|
| Cost-effectiveness of two strategies (direct medical cost differential efficiency strategies measured by the Cesarean rate | Up to discharge / end of study |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Up to discharge/end of study | Summary description of all adverse events, related adverse events and serious adverse events by treatment using MedRA classification. |
| Other specific safety assessments | Up to discharge/end of study | Maternal hyperstimulation syndromes with or without changes of foetal heart rate, uterine hypertonus, rate, rate of postpartum hemorrhage, degree III/IV perineal tears, uterine rupture, neonatal rate of pH \<7.05 and/or BDbase deficit\> 12mmol / L, rates Apgar score \<7 at 5 minutes, transfer rate in neonatal intensive-care unit (NICU), neonatal seizures |
| Other efficacy assessments | Up to discharge/end of study | Time from 1st treatment administration to delivery, ocytocine administration and dose, occurrence of instrumental delivery, occurrence of spontaneous delivery |
| Participant satisfaction assessment | Up to discharge/end of study | Maternal satisfaction using visual analog scale and questionnaire |
Countries
France
Outcome results
None listed