Condition category
Pregnancy and Childbirth
Date applied
09/01/2006
Date assigned
09/01/2006
Last edited
13/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M.E.B. Rijnders

ORCID ID

Contact details

TNO Quality of life
P.O. Box 2215
Leiden
2301 CE
Netherlands
+31 (0)71 5181889

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 measures

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes