Effectiveness and safety of outpatient versus inpatient balloon cervical ripening preceding induction of labour

Not Applicable

• Conditions: induction of labour; cervical ripening; Reproductive Health and Childbirth - Childbirth and postnatal care

• Registration Number: ACTRN12621001328864
• Lead Sponsor: Madeleine Jones

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-29
• Last Update Posted: 5 September 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 3672

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).

Study & Design

• Study Type: Observational
• Study Design: Not specified