Intra uterine pressure monitoring for augmentation or induction of labour with intravenous oxytocin: Benefits and costs.

To evaluate the effectiveness of the use of an intra uterine pressure catheter (IUPC) in comparison to external monitoring of uterine activity during (I) augmentation after arrest of labor OR (II) induction of labour with intravenous oxytocin. Does the potentially more accurate monitoring of uterine activity with IUPC lead to a better outcome of labour and delivery in a study that radomizes the use of an IUPC?

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25086

Enrollment

1350

Registered

2005-09-09

Start date

2004-07-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Monitoring frequency and strenght of uterine contractions by IUPC (intervention) or external monitoring (control) during induction or augmentation of labour with intravenous oxytocin.

Interventions

Intra uterien pressure monitoring with a catheter during labour.

Eligibility

Inclusion criteria

Inclusion criteria: Women with the indication to induce labour or to stimulate the contractions with intravenous oxytocin in case of arrest of labour.

Exclusion criteria

Exclusion criteria: 1. Women with a history of caesarean section; 2. Gestational age<36 weeks; 3. Intra uterine fetal death; 4. Breech presentation; 5. Multiple pregnancy; 6. Maternal age<18 years; 7. HIV- or hepatitis B-infection; 8. Inta uterien infection; 9. Contra indication for amniotomy; 10. Participation in another RCT.

Design outcomes

Primary

Measure	Time frame
The number of instrumental deliveries, i.e. caesarean sections and/or assisted vaginal delivery.	—

Secondary

Measure	Time frame
1. The occurrence of neonatal admittance to NICU; 2. Need for antibiotics by mother or child; 3. Total amount of oxytocin used; 4. Complications; 5. Time to delivery and costs.	—

Contacts

Public ContactJ.J.H. Bakker

Academic Medical Center (AMC), Department of Obstetrics and Gynaecology, H3-107, P.O. Box 22660

j.j.bakker@amc.uva.nl+31 (0)20 5669111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)