Costs and effects of amniotomy at home for induction of post-term pregnancy

ISRCTN	ISRCTN47736435
DOI	https://doi.org/10.1186/ISRCTN47736435
Protocol serial number	NTR504
Sponsor	Midwifery Academy Amsterdam (The Netherlands)
Funder	Not provided at time of registration

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

TNO Quality of life
P.O. Box 2215
Leiden
2301 CE
Netherlands

Phone	+31 (0)71 5181889

Study information

Primary study design	Interventional
Study design	Multicentre randomised active-controlled parallel-group trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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
Key secondary outcome measure(s)	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
Completion date	01/10/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes