Costs and effects of amniotomy at home for induction of post-term pregnancy
| ISRCTN | ISRCTN47736435 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47736435 |
| Secondary identifying numbers | NTR504 |
- Submission date
- 09/01/2006
- Registration date
- 09/01/2006
- Last edited
- 13/06/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr M.E.B. Rijnders
Scientific
Scientific
TNO Quality of life
P.O. Box 2215
Leiden
2301 CE
Netherlands
| Phone | +31 (0)71 5181889 |
|---|
Study information
| Study design | Multicentre randomised active-controlled parallel-group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Costs and effects of amniotomy at home for induction of post-term pregnancy in low-risk women: a pragmatic randomised controlled trial |
| Study acronym | SERINAM |
| Study objectives | We hypothesise that in low-risk women amniotomy at home for post-term pregnancy will result in more spontaneous birth (defined as labour and birth without any obstetric intervention but amniotomy) resulting in lower costs during birth. |
| Ethics approval(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Pregnancy, post-term pregnancy |
| Intervention | If referral for post-term pregnancy is planned within the next 24 hours, randomisation takes place: 1. The intervention group will receive amniotomy at home and expectant management of labour for 12 hours 2. The control group will be referred to an obstetrician at 294 days and receives usual standard care |
| Intervention type | Other |
| Primary outcome measure | 1. Percentage of women that will deliver without obstetric interventions besides amniotomy 2. Data of pregnancy outcome, performed management and obstetric interventions are obtained from midwives and obstetricians with a CRF designed for this study 3. Data regarding patient expectations of birth and birth management are obtained from participating women by questionnaire. This will take place in pregnancy between 292-294 days but before randomisation. 4. Data about patient satisfaction and patient costs are obtained by questionnaire within 1 month postpartum |
| Secondary outcome measures | 1. Proportion caesarean section and admission to the neonatal intensive care unit (NICU) 2. Other obstetric interventions on maternal or foetal indication, pain relief, maternal and foetal morbidity, medical and patient costs, patient satisfaction |
| Overall study start date | 01/10/2004 |
| Completion date | 01/10/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 500 |
| Key inclusion criteria | 1. Informed consent 2. Women with a single foetus in cephalic position 3. Pregnancy of 292 days or more 4. Receiving prenatal care from a midwife in a freestanding midwifery practice |
| Key exclusion criteria | 1. A history of neonatal infection 2. A history of endometritis 3. A history of stillbirth 4. A positive GBS culture 5. A suboptimal foetal condition 6. Contractions 7. Rupture of membranes 8. Communication problems |
| Date of first enrolment | 01/10/2004 |
| Date of final enrolment | 01/10/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
TNO Quality of life
Leiden
2301 CE
Netherlands
2301 CE
Netherlands
Sponsor information
Midwifery Academy Amsterdam (The Netherlands)
Not defined
Not defined
Louwesweg 6
Amsterdam
1066 EC
Netherlands
| Phone | +31 (0)20 5124231 |
|---|---|
| kvjry@slz.nl | |
"ROR" |
https://ror.org/02nt7ap43 |
Funders
Funder type
Not defined
Not provided at time of registration
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 |
