Mechanical cervicAl ripeninG for Women With PrOlongedPregnancies
Avainsanat
Abstrakti
Päivämäärät
| Viimeksi vahvistettu: | 08/31/2019 |
| Ensimmäinen lähetys: | 09/05/2016 |
| Arvioitu ilmoittautuminen lähetetty: | 09/13/2016 |
| Ensimmäinen lähetetty: | 09/19/2016 |
| Viimeisin päivitys lähetetty: | 09/24/2019 |
| Viimeisin päivitys lähetetty: | 09/25/2019 |
| Todellinen opintojen alkamispäivä: | 01/26/2017 |
| Arvioitu ensisijainen valmistumispäivä: | 12/11/2018 |
| Arvioitu tutkimuksen valmistumispäivä: | 12/11/2018 |
Ehto tai tauti
Interventio / hoito
Device: Mechanical cervical ripening
Drug: Pharmacological cervical ripening
Vaihe
Varren ryhmät
| Varsi | Interventio / hoito |
|---|---|
| Experimental: Mechanical cervical ripening mechanical cervical ripening with a Cook® Cervical Ripening Balloon | Device: Mechanical cervical ripening The mechanical cervical ripening is a double transcervical balloon. The device used in the study is the Cook® Cervical Ripening Balloon with CE marked (commercialized by the Cook® laboratory, ref JCRBS-184000). It is a silicone double balloon catheter. Maximum balloon inflation is 80 mL/balloon.
It will be used in accordance with user manual |
| Active Comparator: Pharmacological cervical ripening pharmacological cervical ripening with a 10mg slow releasing system of Dinoprostone (Propess®) | Drug: Pharmacological cervical ripening The comparative pharmacological procedure is a vaginal slow releasing system of dinoprostone. The form used in the study is Propess (Ferring pharmaceuticals) containing 10mg of dinoprostone (prostaglandin E2).
It will be used in accordance with Summary of Product Characteristics |
Kelpoisuusehdot
| Tutkimukseen soveltuvat iät | 18 Years Vastaanottaja 18 Years |
| Sukupuolet, jotka ovat kelpoisia tutkimukseen | Female |
| Hyväksyy terveelliset vapaaehtoiset | Joo |
| Kriteeri | Inclusion Criteria: - Pregnant women - ≥ 18 years old - With a singleton cephalic pregnancy between ≥41+0 weeks and ≤ 42+0 weeks of gestation - Gestational age estimated from the first trimester ultrasound (realized between 11 and 13+6 weeks of gestation) - With a decision of induction of labour - Written informed consent obtained from subject - Subject covered by or having the rights to the French Social Security system Exclusion Criteria: - Bishop score ≥ 6 (favourable cervix) - Non cephalic presentation (breech, transverse) - Severe preeclampsia defined as the presence of preeclampsia with at least one of the following items : - Severe maternal hypertension (systolic blood pressure ≥ 160 mm Hg and/or diastolic blood pressure ≥ 110 mm Hg) - Renal failure with oliguria (< 500 ml/24h) or creatinine > 135μmol/L, or proteinuria > 5 g/day - Pulmonary oedema, epigastric pain or HELLP syndrom (hemolysis, elevated liver enzyme, low platelets) - Eclampsia or neurologic persisting symptoms (visual disturbances, headache, increased reflexes) - Thrombopenia < 100 G/L - Prior caesarean section or uterine scar - Placenta praevia - Suspected genital herpes infection - Known VIH seropositivity (confirmed by blood serology) - Premature rupture of membranes (PROM - continual leaking of amniotic fluid or positive test in favour of PROM) - Foetus with suspected severe congenital abnormalities - Pathological fetal heart rate - Contra-indications to Propess® - Contra-indications for using Cook® Cervical Ripening Balloon - Women under guardianship or trusteeship |
Tulokset
Ensisijaiset tulosmittaukset
1. Caesarean section rate for non-reassuring fetal status. [Up to 2 days after cervical ripening]
Toissijaiset tulosmittaukset
1. Time between cervical ripening and delivery in hours [Up to 2 days after cervical ripening]
2. Delivery rate after 12 and 24 hours of cervical ripening [up to 2 days after cervical ripening]
3. Induction with oxytocin [up to 2 days after cervical ripening]
4. Total dose of oxytocin required for induction of labour [up to 2 days after cervical ripening]
5. Uterine hyper stimulation defined as more than 6 contractions by 10 minutes over a 30 minutes period [up to 2 days after cervical ripening]
6. Requirement for tocolysis during cervical ripening or during labour [up to 2 days after cervical ripening]
7. Suspicious or pathological fetal heart rate [up to 2 days after cervical ripening]
8. Uterine rupture [up to 2 days after cervical ripening]
9. Use of analgesics during labour [up to 2 days after cervical ripening]
10. Use of antibiotics during labour [up to 2 days after cervical ripening]
11. Indication for caesarean delivery other than non-reassuring FHR [up to 2 days after cervical ripening]
12. Type of vaginal delivery [up to 2 days after cervical ripening]
13. Maternal intra partum infection [up to 2 days after cervical ripening]
14. Maternal post partum infection [up to 2 days after cervical ripening]
15. Maternal post partum haemorrhage [up to 2 days after cervical ripening]
16. Maternal blood transfusion [up to 2 days after cervical ripening]
17. Neonatal apgar score [at 1, 3, 5 and 10 minutes after delivery]
18. Neonatal arterial ph [at delivery]
19. Intensive care unit for newborn [up to 5 days after cervical ripening]
20. Neonatal respiratory insufficiency [up to 5 days after cervical ripening]
21. Birth asphyxia [up to 5 days after cervical ripening]
