Methods | RCT. | |
Participants | Setting: women attending hospital in Florida, USA. (67 women recruited, 55 included in analyses.) Inclusion criteria: women with PPROM < 37 weeks, singleton. Women observed for 72 hrs and labour not started, no signs of infection, amniotic fluid > 2 cm, cephalic presentation, cervical dilatation < 4 cm, resident in the county. Membrane rupture confirmed by positive fern, or pooling tests and decrease of amniotic fluid on ultrasound Exclusion criteria: labour started during 72 hrs surveillance period, membranes resealed and no further leakage within 72 hrs, oligohydramnios, lived outside county, not consented, maternal condition precluded discharge |
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Interventions | Women were evaluated before randomisation and cervical cultures obtained. All women commenced antibiotic treatment according to local protocol. If cultures were negative antibiotics were stopped, if positive then treatment according to local protocol. Testing included fetal lungmaturity with offer of steroids for lungmaturation until 34 weeks. No tocolytic drugs were used. Randomisation was carried out after the surveillance period Intervention group: discharge home after surveillance period with daily charting of fetal movements and weekly review. Women were re-admitted if there was evidence of labour or non-reassuring fetal movements Comparison group: routine care in hospital. Both groups were encouraged to rest in bed. Daily recording of fetal movements. NST and blood count, ultrasound and sterile speculum examination weekly. Women were delivered at 37 weeks’ gestation if the cervix was favourable, and all women by 40 weeks |
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Outcomes | Perinatal mortality, neonatal infection, maternal chorioamnionitis, latency period, gestational age at birth, respiratory distress syndrome, NICU admission, birthweight, cost of care | |
Notes | ||
Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Unclear | Not described. |
Allocation concealment? | Unclear | Described as “sealed envelopes”. |
Incomplete outcome data addressed? All outcomes |
Unclear | 67 women were recruited but randomisation did not occur until after the surveillance period. Leakage stopped and membranes resealed in 10 women. One woman in each group was described as “non compliant”. 55 women included in the analyses |
Free of selective reporting? | Yes | None apparent. |
Free of other bias? | Yes | None apparent. |