Sequential use of double-balloon catheter and oral misoprostol versus oral misoprostol alone for induction of labour at term (CRBplus trial): a multicentre, open-label randomised controlled trial
| Autor: | Benjamin Tuschy, Christel Weiss, Ekkehard Schleussner, F. Hägele, J Ziegler, J Siemer, Marc Sütterlin, J Kirscht, Sebastian Berlit, Sven Kehl |
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| Rok vydání: | 2014 |
| Předmět: |
Adult
Anesthesia Epidural medicine.medical_specialty Catheters Adolescent Population Administration Oral Oxytocin Catheterization law.invention Young Adult Randomized controlled trial Pregnancy law Oxytocics medicine Anesthesia Obstetrical Humans Labor Induced education Cervix Misoprostol education.field_of_study Cesarean Section Vaginal delivery Obstetrics business.industry Obstetrics and Gynecology Delivery Obstetric Combined Modality Therapy Double balloon catheter Catheter Treatment Outcome medicine.anatomical_structure Female Open label business Cervical Ripening medicine.drug |
| Zdroj: | BJOG: An International Journal of Obstetrics & Gynaecology. 122:129-136 |
| ISSN: | 1470-0328 |
| DOI: | 10.1111/1471-0528.13116 |
| Popis: | Objective To evaluate the efficacy of inducing labour using a double-balloon catheter and oral misoprostol sequentially, in comparison with oral misoprostol alone. Design A multicentre randomised controlled trial. Setting Five hospitals in Germany. Population A total of 326 pregnant women with an unfavourable cervix undergoing labour induction at term. Methods Women were randomly assigned according to a computer-generated allocation sequence to sequential use of double-balloon catheter and oral misoprostol (study group) or oral misoprostol alone (control group). In the study group, the double-balloon catheter was used the first day before starting oral misoprostol the second day. Main outcome measures The primary outcome measure was the induction-to-delivery interval, and a further outcome parameter was delivery within 48 hours. Results The median times for induction of labour until delivery were 32.4 hours in the study group and 22.5 hours in the control group (P = 0.004). This difference was not seen when evaluating according to parity (nulliparous, P = 0.19; parous, P = 0.06). The rate of vaginal delivery within 48 hours did not differ between both groups. The number of applications of misoprostol (two versus three, P |
| Databáze: | OpenAIRE |
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