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. 2017 Mar 3;2017(3):CD004735. doi: 10.1002/14651858.CD004735.pub4

Mercer 1993.

Methods RCT
Duration of study: 1 March 1991‐31 July 1992
Participants Setting: University of Tennessee, Memphis, USA
Participants: 93 women
  • 46 women were randomised to induction of labour

  • 47 women were randomised to expectant management


Inclusion criteria
  • Confirmed premature rupture of the membranes at 32 weeks‐36 weeks 6 days

  • Amniotic fluid testing suggestive of fetal pulmonary maturity


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)

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

  • 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

  • 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

    • subgrouped into suspected and confirmed sepsis:

      • suspected neonatal sepsis: clinical findings suggestive of neonatal infection or persistent leucopenia with a WBC count < 4000/mm3 or a C‐reactive protein level elevated greater than 0.6;

      • confirmed neonatal sepsis: infants with symptoms of sepsis and positive blood cultures

  • Abnormal fetal heart rate pattern

  • Birthweight

  • Apgar scores

  • Respiratory distress:

    • required oxygen therapy (at least 40%) at least 24 h in absence of other identifiable cause

  • Pneumonia

  • Necrotising enterocolitis

  • Intraventricular haemorrhage

  • Duration of neonatal hospital stay

  • Mortality

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.

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