No registrations found.
ID
Source
Brief title
Health condition
Monitoring frequency and strenght of uterine contractions by IUPC (intervention) or external monitoring (control) during induction or augmentation of labour with intravenous oxytocin.
Sponsors and support
Intervention
Outcome measures
Primary outcome
The number of instrumental deliveries, i.e. caesarean sections and/or assisted vaginal delivery.
Secondary outcome
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.
Background summary
In The Netherlands, approximately 10.000 deliveries are induced with oxytocin and 15.000 deliveries are augmented each year (LVR 2, 2002).
Many clinicians monitor frequency and strength of contractions with an intrauterine pressure catheter (IUPC). It is questionable whether monitoring contractions with IUPC is beneficial in terms of maternal or fetal outcome and whether it is cost effective.
- The aim of the study is to evaluate the effectiveness of IUPC in comparison to external monitoring during induction of labour.
Women will be at random allocated to placement of an IUPC (intervention group) or external uterine activity monitoring (control group).
- The primary outcome measure will be the number of instrumental deliveries, i.e. caesarean sections and/or assisted vaginal delivery.
- Secondary outcome measures are the occurrence of neonatal admittance to ICU, need for antibiotics by mother or child, total amount of oxytocin used, complications, time to delivery and costs.
- The study will be designed as an equivalence study. Under the assumption of equal neonatal and maternal morbidity, it is hypothesised that IUPC will reduce the number of instrumental deliveries from 25% to 16%. Analysis will be by intention to treat.
Study objective
Our hypothesis is that use of an IUPC, during augmentation or induction of labour with intravenous oxytocin, will reduce the number of instrumental deliveries from 25% to 16%.
Study design
N/A
Intervention
Intra uterien pressure monitoring with a catheter during labour.
Department of Obstetrics and Gynaecology,
H3-107,
P.O. Box 22660
J.J.H. Bakker
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5669111
j.j.bakker@amc.uva.nl
Department of Obstetrics and Gynaecology,
H3-107,
P.O. Box 22660
J.J.H. Bakker
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5669111
j.j.bakker@amc.uva.nl
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL247 |
NTR-old | NTR285 |
Other | : N/A |
ISRCTN | ISRCTN13667534 |