Skip to content

Induction of labour in hospital with a Foley catheter or oral misoprostol versus induction of labour at home with a Foley catheter or oral misoprostol

Induction of labour in hospital with a Foley catheter or oral misoprostol versus induction of labour at home with a Foley catheter or oral misoprostol - PROBAAT-III

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON48395
Enrollment
2828
Registered
2019-10-03
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Induction of labour

Interventions

1. Misoprostol at home 2. Foley catheter at home.

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Vital singleton pregnancy in cephalic presentation Intact membranes Gestational age of 37 weeks or more Unfavourable cervix (Bishop score

Exclusion criteria

Exclusion criteria: History of a Caesarean section or other uterine surgery with risk of uterine rupture Non-reassuring cardiotocography Suspected severe fetal growth restriction defined as EFW

Design outcomes

Secondary

MeasureTime frame
Number of Foley catheters used/ misoprostol gifts Induction to delivery time Spontaneous or artificially ruptured membranes More than one induction agent required Mode of delivery Use of analgesics during labour Use of oxytocin (for induction or augmentation) Use of tocolytics Postpartum hemorrhage, need for a blood transfusion Uterine hyperstimulation Maternal death Cardiorespiratory arrest Hysterectomy for any complications resulting from birth Intensive care admission Pulmonary embolus or stroke Maternal birth trauma (2nd, 3rd or 4th degree tears) Maternal satisfaction/ preferences about both induction and labour Total admission time, ante and postpartum. Total amount of re-admissions before scheduled admission in home group and reasons for readmission Maternal infection Meconium stained liquor Gender Birth weight Apgar scores Admissions to the neonatal ward/NICU and reason why Extensive cost analysis (see protocol paragraph 8.1.2)

Primary

MeasureTime frame
The main endpoint regarding safety will be a composite outcome of neonatal asphyxia (defined as a neonatal pH*7.05 and/or 5 minute Apgar

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)