Costs and effects of induction of labour at 41 weeks compared to waiting for spontaneous labour until 42 weeks. |
|- candidate number||12374|
|- NTR Number||NTR3431|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||14-mei-2012|
|- Secondary IDs||171202008 / 2011/ 361 / NL 38455.018.11; ZonMw / METC / CCMO|
|- Public Title||Costs and effects of induction of labour at 41 weeks compared to waiting for spontaneous labour until 42 weeks. |
|- Scientific Title||Costs and effects of induction of labour versus expectant management in women
with impending post-term pregnancies: The 41 week vs. 42 week dilemma.
|- ACRONYM||INDEX-study/ INDEX-trial|
|- hypothesis||Post-term pregnancy (≥ 42 weeks) is associated with increased perinatal morbidity and mortality and is considered as a high-risk stage which requires specialist surveillance and induction of labour at some stage. However, there is uncertainty in The Netherlands on the optimal timing of induction for post-term pregnancy, leading to practice variation and strong debates between caregivers regarding pros and cons of labour induction for impending post-term pregnancy. The literature on this subject is ambiguous. To solve the policy problem in the Netherlands we will conduct a randomised controlled trial to evaluate the cost and effectiveness of a policy of labour induction at 41 weeks versus expectant management until 42 weeks in low risk women. We will study adverse perinatal outcome, adverse maternal outcomes, client satisfaction, preferences and costs.|
|- Healt Condition(s) or Problem(s) studied||Post-term pregnancy, Neonatal and maternal effects|
|- Inclusion criteria||Low risk women > 18 years with a singleton pregnancy in stable cephalic position and a certain gestational age of 41 (-2/+2) weeks.|
|- Exclusion criteria||1. Obstetrical indications for secondary care (hypertension [diastolic blood pressure 90 mmHg or more, systolic blood pressure 140 mmHg or more], proteinuria 3g/L or more, suspected growth retardation, gestational diabetes, previous Caesarean section, multiple pregnancy);|
2. Non-reassuring fetal status [no fetal movements, abnormal fetal heart rate at auscultation];
3. Pre-existent maternal illnesses (heart -/ kidney diseases);
4. Known fetal congenital anomalies or abnormal karyotype;
5. Non certain gestational age of pregnancy;
6. <18 years.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2012|
|- planned closingdate||1-mei-2014|
|- Target number of participants||1800|
|- Interventions||Intervention Group (induction of labour at 41+0/2 weeks):|
Women randomised to induction of labour will be referred to the cooperating hospital for induction of labour. If necessary, labour induction will be preceded by artificial cervical ripening. Induction of labour should be started preferably within 24 hours after randomisation, although the protocol will allow a period of 48 hours for logistic reasons. Women with a cervix that is judged to be 'ripe' at vaginal examination (Bishop Score of 6 or more), will have labour induced with amniotomy and, if labour does not start within 1 hour, augmentation with oxytocin. In case rupturing of membranes is not possible, cervical ripening will be stimulated with the use of all methods of induction as mentioned in our national guidelines. In case the cervix is judged to be unripe the day after priming, cervical ripening will be repeated. All patients in the intervention group will be monitored clinically until after delivery.
Control Group (expectant management until 42 weeks):
Women allocated to expectant management await spontaneous onset of labour until 42 weeks. In the expectant management group, intervention is recommended in case the foetal condition does not justify expectant management, such as reduced foetal movements reported by the mother, or (when there is a consultation in secondary care), non-optimal CTG or oligohydramnios. In case an indication rises for induction of labour, for example prelabour rupture of membranes for > 24 hours or meconium stained liquor, induction of labour is indicated. When the monitoring reveals no abnormity, the women will be referred back to the midwifery practice where controls will be performed according to local protocol until 42 weeks. At 42 weeks women will be referred to secondary care for induction of labour as stated in the intervention group (41 weeks).
|- Primary outcome||The primary outcome will be a composite of perinatal mortality and neonatal morbidity. Adverse perinatal outcomes are defined as a composite of perinatal mortality, a 5-minute Apgar-score below 7 and/or an arterial pH below 7.05, meconium aspiration syndrome, plexus brachialis injury, intracranial hemorrhage and/or NICU admission. The meconium aspiration syndrome is defined as respiratory distress in the first four hours after birth and categorized as severe (requiring assisted mechanical ventilation) or moderate (requiring oxygen for at least 48 hours or at a concentration of 40 percent or greater but without mechanical ventilation). A team of three neonatologists who are blinded to the treatment groups will determine which infants meet the criteria for moderate or severe meconium aspiration syndrome. |
|- Secondary outcome||Secondary outcomes will be maternal outcomes as instrumental delivery (instrumental vaginal delivery, Caesarean section), pain treatment (epidural, remifentanyl, pethidin), hemorrhage and severe perineal injury (third- or fourth-degree perineal tear). |
|- Timepoints||At study-entry clinical data like age, ethnicity, parity, and gestational age are collected. Cervical ripeness will be assessed by digital examination using the Bishop score. At delivery relevant data will be collected for the assessment of perinatal outcomes such as gestational age at birth, birth weight, condition at birth (Apgar scores, Umbilical artery pH), meconium aspiration and NICU admission (type and days). Perinatal mortality and morbidity will be specified. For the mother data will be collected on treatment for pain relief, mode of delivery and adverse outcomes like perineal injury and hemorrhage post partum. We will use standardised case record forms that have been established in previous studies. Apart from the collection of clinical data, each woman will complete questionnaires addressing health related quality of life (MFI, EQ-5D, SF-36, EuroQoL, HUI-III), state anxiety (STAI) as well as a questionnaire containing information on pain and well being. We will develop a questionnaire to measure satisfaction with the allocated strategy, pregnancy period after randomisation, birth and the postpartum period based on the Consumer Quality Index, Cambridge Worry Scale (worries in pregnancy), W-DEQ (fear of childbirth) the Labor Agentry Scale (control during birth) , Mackey Childbirth Satisfaction Rating Scale (satisfaction) and Greater Expectations (expectations and experiences with birth) (Wiegers 2009, Green 2009, Wijma 1998, Hodnett 1987, Goodman 2004). Questionnaires will be completed at baseline after randomisation, two days after randomisation, and 1 week and 6 weeks after delivery. A pain scale will be completed at the day of delivery. Quality of life will also be measured after 6 weeks. Women can fill in the questionnaires online or on paper.|
|- Trial web site||http://www.studies-obsgyn.nl/index|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. E. Miranda, de|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. B.W. Mol|
|- Sponsor/Initiator ||NVOG, KNOV|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||INDEX study:|
Costs and effects of induction of labour versus expectant management in women with impending post-term pregnancies: the 41 week - 42 week dilemma.
Post-term pregnancy is associated with increased perinatal morbidity and mortality and is considered as a high-risk stage which requires specialist surveillance and induction of labour at some stage. However, there is uncertainty in The Netherlands on the policy concerning the timing of induction for post-term pregnancy, leading to practice variation and strong debates between caregivers regarding pros and cons of labour induction for impending post-term pregnancy. To solve this dilemma in the Netherlands we propose a randomised trial to evaluate the effectiveness, costs and cost-effectiveness analysis of policy of labour induction at 41 weeks versus expectant management until 42 weeks in low risk women. We will study adverse perinatal outcome, adverse maternal outcomes, client satisfaction, preferences and costs.
Multicentre randomised controlled clinical trial with cost-effectiveness analysis.
Low risk women with a singleton pregnancy and a certain gestational age of 41 (-2/+2) weeks.
Labour induction at 41 weeks, if necessary proceeded by artificial cervical ripening, versus expectant management until 42 weeks.
The primary outcome will be a composite of perinatal mortality and neonatal morbidity. Adverse perinatal outcomes are defined as, a 5-minute Apgar-score below 7 and/or an arterial pH below 7.05, meconium aspiration syndrome, plexus brachialis injury, intracranial hemorrhage and/or NICU admission.
Secondary outcomes will be maternal outcomes: instrumental delivery (instrumental vaginal delivery, Caesarean section), pain treatment (epidural, remifentanyl, pethidin), hemorrhage and severe perineal injury (third- or fourth-degree perineal tear). Other outcomes are maternal experience of pain, maternal satisfaction and quality of life, client preferences for induction of labour or expectant management, and the extent to which these preferences are influenced by the attributes of obstetric care and socio-demographic factors.
The analysis will be by intention to treat. Based on the systematic review, we may anticipate that induction of labour will reduce the adverse perinatal outcome rate from 3% to 1%. We need a sample size of two groups of 825 women (1650 women) to achieve 80% power in rejecting the null hypothesis of no difference, using an alpha of a two-sided Z test with continuity correction.
We will collect data alongside the trial to estimate the costs and cost-effectiveness of immediate delivery and expectant management from the societal perspective.
Total study time is 48 months. Preparation time four months, recruitment 38 months, analysis and report six months.
|- Main changes (audit trail)|
|- RECORD||14-mei-2012 - 2-jun-2012|
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