Costs and effects of induction of labour at 41 weeks compared to waiting for spontaneous labour until 42 weeks.

Costs and effects of induction of labour versus expectant management in women with impending post-term pregnancies: The 41 week vs. 42 week dilemma.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25131

Enrollment

1800

Registered

2012-05-14

Start date

2012-05-01

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 and its neonatal and maternal effects.

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

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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).	—

Contacts

Public ContactE. Miranda, de

Postbus 22660

e.demiranda@amc.uva.nl+31 (0)20 5664056

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)