|- candidate number||1827|
|- NTR Number||NTR504|
|- Date ISRCTN created||9-jan-2006|
|- date ISRCTN requested||13-dec-2005|
|- Date Registered NTR||14-nov-2005|
|- Secondary IDs||N/A |
|- Public Title||Costs and effects of amniotomy at home for induction of post term pregnancy.|
|- Scientific Title||Costs and effects of amniotomy at home for induction of post term pregnancy in low risk women: A pragmatic randomised controlled trial.|
|- hypothesis||We hypothize that in low risk women amniotomy at home for post term pregnancy will result in more sponteneous birth (defined as labour and birth without any obstetric intervention but amniotomy)resulting in lower costs during birth.|
|- Healt Condition(s) or Problem(s) studied||Pregnancy, Prolonged pregnancy |
|- 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 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.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2004|
|- planned closingdate||1-okt-2007|
|- Target number of participants||500|
|- 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 hours.
The the control group will be refferred to an obstetrician at 294 days and receives usual standard care.
|- Primary outcome||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 outcome||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.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| M.E.B. Rijnders|
|- CONTACT for SCIENTIFIC QUERIES|| M.E.B. Rijnders|
|- Sponsor/Initiator ||Midwifery Academy Amsterdam|
(Source(s) of Monetary or Material Support)
|- Brief summary||In the Dutch obstetric system a distinction is made between low-risk and high-risk birth. |
Low risk births are attended by a primary care caregiver (midwife or G.P.) and take place either at home, in a freestanding birth clinic or in hospital.
High- risk deliveries are defined as the presence of conditions which place the woman or baby at risk during birth and take place in hospital attended by a secondary care caregiver (obstetrician).
The distinction in low, medium or high risk is based on national guidelines for obstetric care. About 35% of all deliveries are cared for by a midwife, and 30% of all babies are born at home.
Post term pregnancy (defined as 294 days or more) is associated with perinatal complications and therefore a reason for referral to an obstetrician.
To prevent women to become high risk and thus referred to an obstetrician, amniotomy could be done at home between 292 and 294 days thus trying to induce labour at home.
This might be preferable for women and gives them a last chance to have a “normal” (home) birth.
A RCT in 34 midwifery practices in the Netherlands is set up to estimate the costs and effects of amniotomy at home followed by expectant management of labour compared to usual care for low risk post-term women.
|- Main changes (audit trail)|
|- RECORD||14-nov-2005 - 5-jan-2010|