None listed
Conditions
Brief summary
Induction of labour (IOL) is one of the most frequent obstetric interventions, being performed in more than 100,000 pregnant women in Australia every year. The first phase of IOL consists of preparation of the cervix, which is often done with the placement of a balloon catheter through the birth canal for 12-24 hours. This procedure is effective, safe and generally performed in hospital. This study will not only investigate whether cervical ripening with a balloon catheter can be performed safely and effectively at home after insertion in hospital, but also establish a network of obstetric services in Australia. If we show that cervical ripening with a balloon catheter can be safely and effectively performed at home, this will reduce significantly the number of admissions and healthcare costs.
Interventions
Completion of mechanical cervical ripening (with a balloon catheter) in the outpatient (home) setting.
Data collection will be prospective or retrospective depending on whether the participating centre has commenced outpatient cervical ripening. If the centre is already performing outpatient cervical ripening, data concerning the cervical ripening process and the subsequent labour and delivery will be collected. If the centre has not yet commenced outpatient cervical ripening, data will be co
Completion of mechanical cervical ripening (with a balloon catheter) in the outpatient (home) setting. Data collection will be prospective or retrospective depending on whether the participating centre has commenced outpatient cervical ripening. If the centre is already performing outpatient cervical ripening, data concerning the cervical ripening process and the subsequent labour and delivery will be collected. If the centre has not yet commenced outpatient cervical ripening, data will be collected at the time of presentation for cervical ripening and subsequently for labour and delivery. Data collection will centre on admission for induction of labour, where routine hospital inpatient data collected would include information on the participants personal and antenatal medical history. Therefore, the time period would be isolated to this admission. There are no further planned follow up attendance required. A subgroup of participants who will complete a maternal satisfaction questionnaire will do so during their normal post-natal stay. We aim to collect a questionnaire from 100 or more participants (50 from each arm). Participants will be selected by convenience sampling - women will be approached on the post-natal ward about voluntary participation in the questionnaire at participating sites.
Sponsors
Madeleine Jones
Eligibility
Sex/Gender
All
Healthy volunteers
No
Inclusion criteria
1. For health centres: to be currently performing inpatient cervical ripening with balloon catheters prior to induction of labour at term. 2. For individuals: All women undergoing induction of labour at or after 37 weeks of gestation with an unfavourable cervix requiring balloon cervical ripening (Bishop score < 7). Singleton pregnancy with no major fetal structurally abnormality, cephalic (head-first) presentation and intact membranes.
Exclusion criteria
Induction of labour before 37 weeks of gestation, major fetal structural abnormalities, intrauterine fetal death, multiple pregnancies, anomalous (non-cephalic) presentation, induction of labour without cervical ripening, utilisation of other pharmacological methods (prostaglandins) for cervical ripening when cervical ripening with balloon is contra-indicated or when the placement of the balloon is technically not possible, and necessity of hospital admission for other medical reasons prior to and during the balloon cervical ripening (in both phases).
Outcome results
None listed