Rush 1984.
Methods | RCT. 20 January 1979 to 19 April 1982. Reproductive failure clinic at the Groote Schuur Maternity Centre, Peninsula Maternity and Neonatal Service, Capetown, South Africa. Women entered the study at 15 to 21 weeks' gestation. |
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Participants | Participants (N = 194): high‐risk women for PTL or late abortion. Inclusion criteria:
Exclusion criteria: age > 35 years; smoking > 5 cigarettes/day; medical disorders (cardiac disease, hypertension, diabetes, thyroid disease); obstetric/gynaecological conditions (recurrent 1st trimester abortions, multiple gestation in present pregnancy, congenital uterine abnormality, uterine fibromyomata, previous cervical surgery – cone biopsy, trachelorrhaphy, cervical cerclage); cervix < 2.0 cm long or dilated at entry |
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Interventions | Cervical suture versus no suture | |
Outcomes | Not stated | |
Notes | Additional information and the data base for cross‐checking of the published results provided by the first author | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | “…patients were allocated at random either to have a cervical suture (96 patients) or to be managed without a suture (98 patients) by reference to a series of sealed envelopes.” |
Allocation concealment (selection bias) | Unclear risk | “…reference to a series of sealed envelopes.” |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Impossible to blind to participants and personnel |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated if outcome assessors were blinded |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Loss of participants not stated. Exclusion of participants after randomisation not stated. Intention‐to‐treat analysis: “All but two of 194 women entered into the trial received the management to which they were allocated.” |
Selective reporting (reporting bias) | Low risk | Study protocol not available. The full database was provided by the authors, so any selective reporting unlikely |
Other bias | Low risk | Study was not stopped early. Baseline imbalance: “Although the frequency of two or more previous second trimester abortions or preterm deliveries was somewhat greater in women allocated to cerclage, this difference was not statistically significant.” |