Costs and effects of induction of labour at 41 weeks compared to waiting for spontaneous labour until 42 weeks.
Recruiting
- Conditions
- Post-term pregnancy and its neonatal and maternal effects.
- Registration Number
- NL-OMON25131
- Lead Sponsor
- prioritized bij NVOG/ KNOV
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 1800
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];
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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).