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

Costs and effects of amniotomy at home for induction of post term pregnancy in low risk women: A pragmatic randomised controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21694
Enrollment
500
Registered
2005-11-14
Start date
2004-10-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post term pregnancy defined as a pregnancy of 294 days or more occurs in approximately 6% of all pregnancies and is associated with an increased risk for neonatal morbidity and a small but significant increased risk of neonatal mortality.

Interventions

If referral for post term pregnancy is planned within the next 24 hours, randomisation takes place: The intervention group will receive amniotomy at home and expectant managment of labour for 12 hour

Sponsors

Midwifery Academy Amsterdam Louwesweg 6 1066 EC Amsterdam Telefoon 020 – 512 4231 Fax 020 – 614 0698 E-mail kvjry@slz.nl
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: After informed consent women with a single fetus in cephalic position and a pregnancy of 292 days or more, receiving prenatal care from a midwife in a freestanding midwifery practice are included in the trial.

Exclusion criteria

Exclusion criteria: Exclusion criteria are a history of neonatal infection, endometritis, stillbirth, and in this pregnancy a positive GBS culture, a suboptimal fetal condition, contractions, rupture of membranes or communication problems.

Design outcomes

Primary

MeasureTime frame
Percentage of women that will deliver without obstetric interventions besides amniotomy. Data of pregnancy outcome, performed management and obstetric interventions are obtained from midwives and obstetricians with a for this study designed CRF. Data regarding patient expectations of birth and birth-management are obtained from participating women by questionaire. This will take place in pregnancy between 292-294 days but before randomisation. Data about patient satisfaction and patients costs are obtained by questionaire within 1 month postpartum.

Secondary

MeasureTime frame
Proportion ceasarean section and admission to the NICU. Other obstetric interventions on maternal or fetal indication, pain relief, maternal and fetal morbidity, medical and patients costs, patient satisfaction.

Contacts

Public ContactM.E.B. Rijnders

TNO Quality of life, P.O. Box 2215

meb.rijnders@pg.tno.nl+31 (0)71 5181889

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)