Novel ‘extended balloon labour induction/augmentation’ (EBLIA) device to improve safety of labour induction

Novel ‘extended balloon labour induction/augmentation’ (EBLIA) device to improve safety of labour induction: Preliminary clinical study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

PACTR

Registry ID

PACTR202605920358995

Enrollment

Registered

2026-05-29

Start date

2026-05-01

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy and Childbirth

Interventions

Extended balloon labour induction and augmentation

Routine care control

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Age >18 years Planned labour induction Singleton cephalic pregnancy Gestation 36 weeks or more Suitable for balloon labour induction 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 5cm or more) within 48 hours without use of amniotomy or uterine stimulants	—

Secondary

Measure	Time frame
Mode of birth;Time from insertion to birth;Vaginal birth without use of uterine stimulants or amniotomy;Cervical dilatation at EBLIA balloon expulsion;Cervical dilation reached without uterine stimulants or amniotomy;Use of uterine stimulants;Use of amniotomy;Fetal heart rate parameters (baseline bradycardia or tachycardia, baseline variability, early/variable or late fetal heart rate decelerations);Uterine hyper-stimulation (5 or more contractions per 10 minutes);5-minute Apgar score <7;Birthweight;Neonatal complications;Maternal complications;Qualitative and quantitative data on usability and acceptability to staff and participants, through structured and semi-structured questionnaires	—

Measure

Time frame

Mode of birth;Time from insertion to birth;Vaginal birth without use of uterine stimulants or amniotomy;Cervical dilatation at EBLIA balloon expulsion;Cervical dilation reached without uterine stimulants or amniotomy;Use of uterine stimulants;Use of amniotomy;Fetal heart rate parameters (baseline bradycardia or tachycardia, baseline variability, early/variable or late fetal heart rate decelerations);Uterine hyper-stimulation (5 or more contractions per 10 minutes);5-minute Apgar score <7;Birthweight;Neonatal complications;Maternal complications;Qualitative and quantitative data on usability and acceptability to staff and participants, through structured and semi-structured questionnaires

—

Countries

South Africa

Contacts

Public ContactMandisa Singata Madliki

Co Director

manidsasingata@gmail.com+27661127043

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026