Methods |
RCT Duration of study: 1 March 1991‐31 July 1992 |
Participants |
Setting: University of Tennessee, Memphis, USA Participants: 93 women
Inclusion criteria
Exclusion criteria
Cervical dilatation greater than 2 cm
Persistent regular contractions or progressive labour
Blood or meconium‐stained amniotic fluid
Suspected chorioamnionitis
Any maternal or fetal contraindication to expectant management
Women with fetuses with intrauterine growth restriction
Women with fetuses with congenital malformations
A non‐reassuring fetal heart rate tracing (defined as recurrent decelerations, heart rate greater than 160 beats per minute, or the absence of heart rate accelerations)
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Interventions |
Intervention: intravenous oxytocin infusion Control: expectant management
This included 12 h of continuous fetal heart rate monitoring
Observations performed every 8 h
Women restricted to bed rest
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Criteria for delivery included
progressive labour
chorioamnionitis (defined as a temperature > 100.4°F plus any 2 of the following: fetal or maternal tachycardia, uterine contractions or tenderness, foul smelling amniotic fluid in the absence of other identifiable cause)
non‐reassuring fetal heart rate pattern including persistent fetal tachycardia or recurrent deceleration and positive cultures for Neisseria gonorrhoeae or GBS
Corticosteroids, tocolysis and prophylactic antibiotics not used Vaginal examinations not performed in the absence of labour |
Outcomes |
Maternal
Latency from randomisation to labour
Latency from randomisation to delivery
Duration of maternal hospital stay
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Chorioamnionitis: T > 100.4°F plus 2 of the following:
fetal or maternal tachycardia
uterine contractions or tenderness
foul‐smelling amniotic fluid in the absence of other identifiable cause
Caesarean delivery
Postpartum infection requiring antibiotics
Fetal
-
Neonatal sepsis: required a positive culture for diagnosis
Abnormal fetal heart rate pattern
Birthweight
Apgar scores
-
Respiratory distress:
Pneumonia
Necrotising enterocolitis
Intraventricular haemorrhage
Duration of neonatal hospital stay
Mortality
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Notes |
Gestational age: determined clinically on the basis of menstrual history, earliest ultrasound examination and first clinical assessment
Ruptured membranes diagnosed by: visualisation of amniotic fluid passing from the cervical os on sterile speculum examination or the presence of a pool of fluid in the posterior vaginal fornix that was positive to both Nitrazine paper and ferning tests
Fetal pulmonary maturity was determined on pooled vaginal fluid (foam stability index ≥ 47 considered mature), an amniocentesis was performed in the absence of adequate vaginal fluid.
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Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Computer‐generated random number tables |
Allocation concealment (selection bias) |
Unclear risk |
Not clearly defined. Stated that "blinded" random number tables were used, but no further explanation was given as to what this entailed. |
Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Blinding not possible due to intervention. However this was likely low risk of bias due to objective and specific assessment criteria for outcomes, where lack of blinding did not affect treatment decisions or other aspects of care. |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Neonatologists were not blinded to the perinatal clinical course. It was not specified whether the assessors of maternal outcomes were blinded to their clinical course. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No losses to follow‐up or post‐randomisation exclusions |
Selective reporting (reporting bias) |
Unclear risk |
Outcomes only reported in results. Not pre‐specified |
Other bias |
Low risk |
None noted |