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%.
ID
Bron
Verkorte titel
Aandoening
Monitoring frequency and strenght of uterine contractions by IUPC (intervention) or external monitoring (control) during induction or augmentation of labour with intravenous oxytocin.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The number of instrumental deliveries, i.e. caesarean sections and/or assisted vaginal delivery.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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%.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Intra uterien pressure monitoring with a catheter during labour.
Algemeen / deelnemers
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
Wetenschappers
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Women with the indication to induce labour or to stimulate the contractions with intravenous oxytocin in case of arrest of labour.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL247 |
NTR-old | NTR285 |
Ander register | : N/A |
ISRCTN | ISRCTN13667534 |