Een gerandomiseerde studie naar epidurale analgesie bij aterme barende vrouwen.
|- candidate number||5535|
|- NTR Number||NTR1744|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||1-apr-2009|
|- Secondary IDs||08-T-26 Atrium Medical Centre Parkstad|
|- Public Title||Een gerandomiseerde studie naar epidurale analgesie bij aterme barende vrouwen.
|- Scientific Title||The Randomised Epidural Analgesia in Term delivering women trial.
|- hypothesis||The objective of the study is to assess the impact of a proactive policy of offering EA at the start of labour before maternal request in women with a child in occiput presentation allowed to try a vaginal delivery, on maternal pain reduction, obstetrical complications, neonatal outcomes, and maternal experience of the delivery. Furthermore, we want to gain insight on the basis of which characteristics (attributes) women in labour chose for (prefer) epidural analgesia.
|- Healt Condition(s) or Problem(s) studied||Labour, Pain, Epidural analgesia|
|- Inclusion criteria||Patients in order to be eligible for the trial, women have to: |
1. Be 18 years or older;
2. Bear a singleton child in cephalic presentation;
3. Be under supervision (second line) for their pregnancy in one of the participating centres (MUMC, AMCP);
4. Have no contraindications for vaginal labour;
5. Have no contraindications for EA:
A. Use of coumarine derivates;
B. LMWH in therapeutic dose;
C. LMWH in profylactic dose, less than 10 hours ago;
D. Thrombocytes < 80 x 109/ L;
E. Use of thrombocytes aggregation inhibitors or anamnestic increased bleeding tendency;
F. Blood clotting disorders;
G. Allergy for used anesthetics;
H. Spine disorders or back infection.
|- Exclusion criteria||Patient in order not to be eligible for the trial, women have to: |
1. Be younger than 18 years;
2. Bear twin pregnancy;
3. Have contraindications for vaginal labour;
4. Have contraindications for EA;
5. Referral by midwife during labour (first line).
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2008|
|- planned closingdate||1-sep-2011|
|- Target number of participants||200|
|- Interventions||Women will be allocated at random into two different groups:|
1. EA group. These women are given an EA as soon as possible as they are in labour, judged by the attending gynaecologist and based on an effaced cervix with at least 2 cm dilation at vaginal examination;
2. Non-EA (restrictive) group. These women receive pain relief only on their explicit request. According to local preferences, several methods of pain relief are allowed, including EA in case other methods have failed.
The medication used in the intervention groups is according to the local protocol of the participating centre and is a regular accepted method for pain relief during labour in the Netherlands.
1. AMCP: nubaine, ropivacaïne/sufentanil;
2. MUMC: pethidine, ropivacaïne/sufentanil.
|- Primary outcome||Primary outcome is maternal pain reduction during delivery, as measured on a VAS pain scale.
|- Secondary outcome||Secondary outcomes are the use of oxytocin, the number of instrumental vaginal deliveries, the number of caesarean sections, the duration of the second stage of labour, maternal hypotension, motor block, urine retention, fever, used antibiotics, used anaesthetics, neonatal condition (including Apgar scores and umbilical blood gasses), maternal experience and quality of life.
|- Timepoints||At study-entry the following variables will be collected from medical records: age, ethnic origin, obstetric history, general health history, gestational age, systolic and diastolic blood pressure, biometric parameters, and maternal weight. After informed consent and before randomisation, questionnaires will be filled in: Qol (Rand-36), beliefs about epidural analgesia questionnaire (BEAQ) and the pain catastrophizing scale (PCS).
During delivery, progression of labour, maternal vital signs, sensory levels, and motor block (Bromage score) are recorded at regular intervals by the attending obstetrician. A pain visual analog scale (VAS) score and the fear of delivery scale is recorded by the woman before every bimanual toucher.
At delivery: gestational age at birth, mode of delivery, birth weight, condition at birth (Apgar scores, umbilical artery pH) are recorded by the attending obstetrician.
Eight hours after delivery: a VAS score will be filled in by the woman.
Six weeks after delivery: questionnaires will be filled in by the woman. These will include Qol (Rand-36), Childbirth Experience Questionnaire.
Neonate: Neonatal admission (type and days), neonatal mortality and morbidity until date of discharge from hospital and six weeks post partum will be collected from the medical records. In case of a non-perfect score at 1 week after birth, the neonate will be followed for 6 weeks using the composite outcome score.
|- Trial web site||www.treattrial.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. Martine M.L.H. Wassen|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Martine M.L.H. Wassen|
|- Sponsor/Initiator ||Atrium Medisch Centrum Parkstad|
(Source(s) of Monetary or Material Support)
|Atrium Medisch Centrum Parkstad |
|- Brief summary||OBJECTIVE: |
Epidural analgesia (EA) is an effective method to reduce labour pain, but is not frequently applied in the Netherlands. In this proposal, we determine the beliefs and characteristics of women about epidural analgesia and we asses the impact of a proactive policy of offering EA at the start of labour as compared to a restrictive policy on maternal pain reduction, obstetrical complications, neonatal outcomes and maternal experience of the delivery. Besides we want to gain insight in the influence of pain catastrophizing on the experienced pain and fear for labour.
Bicentre randomised open label trial. It concerns a pilot study.
Term nulliparous and multiparous women with a child in cephalic presentation, and without contraindications for vaginal labour or EA. Patients will be recruited in 2 hospitals in the Netherlands.
Women will be allocated to the EA group or the non-EA group. In the EA group, women are given an EA as soon as they are in labour. In the non-EA (restrictive) group, women receive pain relief only on their explicit request.
The primary outcome is maternal pain during labour. Secondary outcomes are the use of oxytocin, the number of instrumental vaginal deliveries, the number of caesarean sections, the duration of the second stage of labour, maternal hypotension, motor block, urine retention, fever, obstetric complications, antibiotics and anaesthetics used, neonatal condition, maternal experience of the delivery and quality of life.
SAMPLE SIZE CALCULATION AND DATA ANALYSIS:
We hypothesize that the advantages of EA outweigh the disadvantages, when EA causes a maternal pain reduction of -4 (VAS score 1-10) during the first stage of labour, and -3 during the second stage of labour. In order to be able to detect a pain reduction of 0.4 standard deviation (sd), with a sd of 2.5 on a VAS scale of 1-10, alpha and beta of 0.05 and 0.20, respectively, 99 women are needed in each randomised group.
Statistical analysis will be performed according to the “intention to treat” principle.
|- Main changes (audit trail)|
|- RECORD||1-apr-2009 - 23-sep-2009|
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