Intrauterine pressure monitoring for augmentation or induction of labour with intravenous oxytocin: benefits and costs
| ISRCTN | ISRCTN13667534 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13667534 |
| Secondary identifying numbers | NTR285 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 29/01/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr J.J.H. Bakker
Scientific
Scientific
Academic Medical Centre (AMC)
Department of Obstetrics and Gynaecology, H3-107
Meibergdreef 9
Amsterdam
1100 DD
Netherlands
| j.j.bakker@amc.uva.nl |
Study information
| Study design | Multicentre, randomised, single-blind, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | To evaluate the effectiveness of the use of an IntraUterine 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 randomises the use of an IUPC? |
| Study acronym | The IUPC study |
| Study objectives | Our hypothesis is that use of an intrauterine pressure catheter (IUPC), during augmentation or induction of labour with intravenous oxytocin, will reduce the number of instrumental deliveries from 25% to 16%. |
| Ethics approval(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Pregnancy, labour |
| Intervention | Intrauterine pressure monitoring with a catheter during labour versus external uterine activity monitoring (control group). |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Oxytocin |
| Primary outcome measure | The number of instrumental deliveries, i.e. caesarean sections and/or assisted vaginal delivery. |
| Secondary outcome measures | 1. The occurrence of neonatal admittance to Neonatal Intensive Care Unit (NICU) 2. Need for antibiotics by mother or child 3. Total amount of oxytocin used 4. Complications 5. Time to delivery and costs |
| Overall study start date | 01/07/2004 |
| Completion date | 01/07/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 1350 |
| Key inclusion criteria | Women with the indication to induce labour or to stimulate the contractions with intravenous oxytocin in case of arrest of labour. |
| Key exclusion criteria | 1. Women with a history of caesarean section 2. Gestational age less than 36 weeks 3. Intrauterine foetal death 4. Breech presentation 5. Multiple pregnancy 6. Maternal age greater than 18 years 7. Human immunodeficiency virus (HIV) or hepatitis B infection 8. Intrauterine infection 9. Contraindication for amniotomy 10. Participation in another randomised controlled trial |
| Date of first enrolment | 01/07/2004 |
| Date of final enrolment | 01/07/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Centre (AMC)
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Sponsor information
Academic Medical Centre (AMC) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Obstetrics and Gynaecology
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| Website | http://www.amc.uva.nl/ |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Hospital/treatment centre
Academic Medical Centre (AMC) (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 28/01/2010 | Yes | No |
