Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR504
Study information
Scientific title
Costs and effects of amniotomy at home for induction of post-term pregnancy in low-risk women: a pragmatic randomised controlled trial
Acronym
SERINAM
Study hypothesis
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
Received from the local medical ethics committee
Study design
Multicentre randomised active-controlled parallel-group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/10/2004
Overall trial end date
01/10/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
500
Participant 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
Recruitment start date
01/10/2004
Recruitment end date
01/10/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
TNO Quality of life
Leiden
2301 CE
Netherlands
Sponsor information
Organisation
Midwifery Academy Amsterdam (The Netherlands)
Sponsor details
Louwesweg 6
Amsterdam
1066 EC
Netherlands
+31 (0)20 5124231
kvjry@slz.nl
Sponsor type
Not defined
Website
Funders
Funder type
Not defined
Funder name
Not provided at time of registration
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list