Rock 1984.
| Study characteristics | ||
| Methods | Randomised trial (method not stated) Time of randomisation: evening before surgery Factorial design Power calculation done Timing and duration: 1984 Sponsored by Laboratories Chanterau, France Truly randomised (pack of cards) Time of randomisation: not stated Sequential analysis Location: multi‐centre—4 centres in the USA (Norfolk, Durham, 2 units in New York), 1 in the Netherlands (Amsterdam) and 1 in Colombia (Bogota) Timing and duration: Jan 1978 to Dec 1981 | |
| Participants | Infertile women undergoing open gynaecological microsurgery Condition: bilateral distal tubal obstruction (unilateral if only 1 residual tube) Surgery performed: tubal surgery Preexisting adhesions: not stated Age: < 36 years (mean 28) Mean duration infertility: 10.7 years (range 1 to 18) Infertility work‐up: semen analysis, postcoital test, documentation of ovulation (method not stated), hysterosalpingogram and laparoscopy (90% of women) Number randomly assigned: ? (no exclusions stated) Number analysed: 120 | |
| Interventions | Steroids versus Ringer`s lactate Route of administration: postoperative hydrotubation on the first 3 postoperative days and on day of discharge Dosage/volume: 50 mL Ringer`s lactate, with or without 150 mg hydrocortisone Prophylactic antibiotics: yes | |
| Outcomes | Analysed in review Pregnancy rate (total and live births)
Miscarriage rate Ectopic rate Other outcomes—infection rates and complications after hydrotubation |
|
| Notes | 3‐way trial comparing postoperative hydrotubation, with or without steroids, or no hydrotubation; also included in review on postoperative procedures following tubal surgery | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "A card drawn from a previously randomised deck" |
| Allocation concealment (selection bias) | Unclear risk | Insufficent information to permit judgement |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Insufficent information to permit judgement |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficent information to permit judgement |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data |
| Selective reporting (reporting bias) | Unclear risk | Data presented in full for all outcomes specified, however, no study protocol or trial registry identified for comparison |
| Other bias | Low risk | None |