Preterm Premature Rupture Of Membranes between 34 and 37 weeks: EXpectant management versus Induction of Labour 2

Conditions

Preterm prelabour rupture of membranes Pregnancy and Childbirth Premature rupture of membranes

Annemijn A. de Ruigh, Noor E. Simons, Janneke van ’t Hooft, Aleid G. van Wassenaer‐Leemhuis, Cornelieke S.H. Aarnoudse-Moens et al. (13 authors)

BMJ Open2021-06-017 citations

10.1136/bmjopen-2020-046046

Can neonatal sepsis be predicted in late preterm premature rupture of membranes? Development of a prediction model.

van der Ham DP, van Kuijk S, Opmeer BC, Willekes C, van Beek JJ, Mulder AL, van Loon AJ, Groenewout M, Mantel GD, Bloemenkamp KW, Porath M, Kwee A, Akerboom BM, Papatsonis DN, Metz GC, Nijhuis JG, Mol BW, PPROMEXIL trial group.

2014-02-139 citations

10.1016/j.ejogrb.2014.02.003

Interventions

Participants will be randomised to induction of labour or expectant management. If randomised for induction: same day or the day after. If randomised for expectant management: inductio

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Women presenting with preterm prelabour rupture of the foetal membranes between 34+0 and 37+0 weeks' gestation and have not delivered within 24 hours after rupture of the foetal membranes 3. Women presenting with preterm prelabour rupture of foetal membranes after 26+0 weeks gestation who have not delivered at 34+0 weeks of gestation 4. Single and multiple gestations 5. Women with child in breech presentation can also be included

Exclusion criteria

Exclusion criteria: 1. Monochorionic multiple pregnancies 2. Abnormal (non-reassuring) cardiotocogram (CTG) 3. Meconium stained amniotic fluid 4. Signs of intrauterine infection 5. Major foetal anomalies 6. Being in labour 7. Hemolytic anaemia, elevated liver enzymes and low platelet count (HELLP) syndrome 8. Severe pre-eclampsia

Design outcomes

Primary

Measure	Time frame
Neonatal sepsis, measured immediately on discharge from hospital	—

Secondary

Measure	Time frame
1. Respiratory distress syndrome (RDS) 2. Transient tachypnoea of the newborn 3. Asphyxia 4. Pneumothorax/pneumomediastinum 5. Late onset sepsis 6. Hypoglycaemia 7. Meconium aspiration syndrome 8. Necrotising enterocolitis (NEC) 9. Hyperbilirubinaemia 10. Intraventricular haemorrhage 11. Periventricular leucomalacia 12. Convulsions 13. Other neurological abnormalities and congenital abnormalities Secondary maternal outcome measures: 1. Antepartum haemorrhage 2. Umbilical cord prolapse 3. Signs of chorioamnionitis 4. Maternal sepsis 5. Thrombo-embolic complications 6. Urinary tract infection treated with antibiotics 7. Signs of endometritis 8. Pneumonia 9. Anaphylactic shock 10. Haemolysis, Elevated Liver Enzymes, Low Platelets (HELLP) syndrome 11. Death 12. Incidence of instrumental deliveries 13. Maternal quality of life 14. Maternal intervention reference 15. Costs Other outcomes: Direct medical and non-medical costs, generated by maternal and neonatal resource utilisation during admission and post-discharge follow-up until 6 weeks after randomisation. The economic evaluation will integrate the primary clinical outcome and costs in a cost effectiveness analysis. All outcomes will be measured immediately on discharge from hospital, and also 6 weeks and 6 months post-partum.	—

Measure

Time frame

1. Respiratory distress syndrome (RDS) 2. Transient tachypnoea of the newborn 3. Asphyxia 4. Pneumothorax/pneumomediastinum 5. Late onset sepsis 6. Hypoglycaemia 7. Meconium aspiration syndrome 8. Necrotising enterocolitis (NEC) 9. Hyperbilirubinaemia 10. Intraventricular haemorrhage 11. Periventricular leucomalacia 12. Convulsions 13. Other neurological abnormalities and congenital abnormalities Secondary maternal outcome measures: 1. Antepartum haemorrhage 2. Umbilical cord prolapse 3. Signs of chorioamnionitis 4. Maternal sepsis 5. Thrombo-embolic complications 6. Urinary tract infection treated with antibiotics 7. Signs of endometritis 8. Pneumonia 9. Anaphylactic shock 10. Haemolysis, Elevated Liver Enzymes, Low Platelets (HELLP) syndrome 11. Death 12. Incidence of instrumental deliveries 13. Maternal quality of life 14. Maternal intervention reference 15. Costs Other outcomes: Direct medical and non-medical costs, generated by maternal and neonatal resource utilisation during admission and post-discharge follow-up until 6 weeks after randomisation. The economic evaluation will integrate the primary clinical outcome and costs in a cost effectiveness analysis. All outcomes will be measured immediately on discharge from hospital, and also 6 weeks and 6 months post-partum.

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Countries

Netherlands

Outcome results

None listed