Pregnant participants due for labour induction Pregnancy and Childbirth
Conditions
Interventions
Preliminary proof-of-concept clinical trial:
The initial trial is designed to assess essential safety, performance, feasibility and acceptability and to give an indication of effectiveness and suitabi
Sponsors
Wits Health Consortium, University of the Witwatersrand
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Age >18 years 2. Planned labour induction 3. Singleton cephalic pregnancy 4. Gestation 36 weeks or more 5. Suitable for balloon labour induction 6. Informed consent
Exclusion criteria
Exclusion criteria: Major medical complications such as cardiac disease, diabetes, severe pre-eclampsia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Established labour (cervical dilation 5 cm or more) within 48 hours without use of amniotomy or uterine stimulants measured using clinical assessment of uterine contractions and cervical dilation in cm at during routine labour assessments | — |
Secondary
| Measure | Time frame |
|---|---|
| Mode of birth measured using clinical assessment at birth;Vaginal birth without use of uterine stimulants or amniotomy measured using clinical assessment at birth;Fetal heart rate parameters measured using cardiotocography at during labour;Uterine hyper-stimulation (5 or more contractions per 10 minutes) measured using cardiotocography at during labour;5-minute Apgar score <7 measured using clinical assessment at 5 minutes after birth;Maternal complications measured using clinical assessment at hospital discharge;Usability and acceptability to staff and participants measured using structured and semi-structured questionnaires at postpartum | — |
Countries
South Africa
Contacts
Public ContactG Justus Hofmeyr
Outcome results
None listed