Soihet 1974.
Methods | Randomised trial (method not stated) Time of randomisation ‐ not stated 258 women analysed No withdrawals after randomisation stated Duration of follow up ‐ not stated | |
Participants | Women with primary or secondary infertility with tubal immobility or occlusion. All women underwent tubal surgery involving cuff salpingostomy, tubal reanastomosis, tubal reimplantation, adhesiolysis or any combination of the above, in addition to ventrosuspension, by laparotomy. The procedure was covered by intraperitoneal instillation of chloramphenicol or penicillin and the same antibiotics systemically for 5 days. Mean age and mean duration of infertility not specified. Infertility work up not stated. No exclusion criteria prior to randomisation stated. The trial was carried out at San Marcos University, Lima, Peru. Timing and duration of trial not stated. | |
Interventions | Early postoperative hydrotubation (solution not specified) twice weekly from day 5 to 6 weeks versus late postoperative hydrotubation twice weekly from weeks 6‐12 where the surgery had included Teflon stenting of the fallopian tubes (removed electively after 6 weeks) versus late postoperative hydrotubation twice weekly from week 6‐12 with a solution containing gentamicin where the surgery included tubal suspension in addition to Teflon tube stenting of the fallopian tubes (removed electively after 6 weeks) | |
Outcomes | Outcomes of relevance to this review:
Pregnancy or live birth rate (per woman)
Ectopic pregnancy rate (per woman)
Method of diagnosis of pregnancy: term delivery
Tubal patency rate (of at least 1 fallopian tube, per woman)
Infective morbidity rate (per woman) Other outcomes: Bilateral tubal obstruction rate (per woman) |
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Study stated as randomised. |
Allocation concealment? | Unclear risk | Not stated within text. |
Blinding? All outcomes | Unclear risk | Not stated within text. |
Incomplete outcome data addressed? All outcomes | Low risk | |
Free of selective reporting? | Unclear risk | Unequal numbers randomised into each group could represent deliberate unequal randomisation. |
Free of other bias? | Low risk |