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. 2017 Mar 6;2017(3):CD012031. doi: 10.1002/14651858.CD012031.pub2

Crowther 1989.

Methods Randomisation and allocation concealment: the study used block randomisation without stratification to provide balanced numbers in the study groups. Use of consecutively‐numbered, opaque, sealed envelopes. Researchers involved in allocating the women to the treatment groups were not involved in preparing the randomisation schedule.
Blinding of outcome assessment: paediatrician examining newborn infants was unaware to which group the mother had been allocated.
Documentation of exclusion: no losses to follow‐up.
Participants 139 women with a twin pregnancy and a cervical score of ‐2 or less at or before 34 weeks' gestation attending a special antenatal clinic for multiple pregnancy.
Cervical score is length minus dilatation (cm) of the cervix.
Interventions Women allocated to the intervention group received bed rest in the hospital.
Women allocated to the control group continued conventional outpatient management and were only admitted to the hospital if pregnancy complications occurred.
Outcomes Primary outcomes
  1. Gestational age at delivery (using Dubowitz scoring)

  2. Preterm birth (< 37 weeks)

  3. Small‐for‐gestational age (birthweight < 10th centile by local singleton standards)


Seconcary outcomes
  1. Very preterm birth (< 34 weeks)

  2. Birthweight

  3. Perinatal mortality

  4. Apgar score of < 7 at 1 min and 5 min

  5. Admission to NICU and length of stay

  6. Neonatal and maternal morbidities

Notes Chorionicity: not reported
Sample‐size calculation: reported, 44 women for a 40% (from 80%‐40%) reduction of preterm delivery rate at the 5% level
Intention‐to‐treat analyses: performed
 Compliance: 2 women (3%) in the hospitalisation group did not attend the antenatal ward and 17 women (25%) in the control group were admitted to hospital because of pregnancy complications
 Location: single centre in Harare, Zimbabwe
 Timeframe: 1984
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Block randomisation without stratification to provide balanced numbers in the study groups. Use of a series of consecutively‐numbered, opaque, sealed envelopes. p 851
Allocation concealment (selection bias) Low risk "The researchers involved in allocating the women to the treatment groups were not involved in preparing the randomisation schedule." p 851
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Blinding of participants and personnel was not possible due to the type of intervention (hospitalisation and bed rest compared with no activity restriction at home)
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk "All newborn infants were examined by a paediatrician who was unaware to which group the mother had been allocated." p 851
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No loss to follow‐up and analysis on an intention‐to‐treat basis
Selective reporting (reporting bias) Unclear risk No information provided about trial protocol or predefined outcomes
Other bias Low risk The study appears to be free of other sources of bias