| Methods |
Truly randomised (pack of cards)
Time of randomisation not stated
206 women analysed
No withdrawals after randomisation stated
24‐months follow up |
| Participants |
Women with primary or secondary infertility and distal tubal disease. All women underwent bilateral salpingoneostomy of fimbrioplasty (unilateral if only 1 residual tube). Mean age 28 years (all women were under 36 years old), mean duration of infertility 12 years (range 1‐19 years). The infertility work up consisted of semen analysis, PCT, documentation of ovulation (method not stated), HSG and laparoscopy (90% of women). No exclusion criteria prior to randomisation stated. The trial was multicentre (5 centres) carried out from Jan 1978 to Dec 1981 in the USA (Baltimore, Brooklyn, Durham), Netherlands (Amsterdam) and Colombia (Bogota). |
| Interventions |
Postoperative hydrotubation on 1st, 2nd and 3rd postoperative days and on the day of discharge home with 50mls Ringer's lactate versus 50ml Ringers lactate with 150mg hydrocortisone versus no hydrotubation |
| Outcomes |
Outcomes of relevance to this review:
Total pregnancy rate (per woman)
Live birth rate (per woman)
Miscarriage rate (per woman; rate per intrauterine pregnancy extrapolated)
Ectopic pregnancy rate (per woman)
Method of diagnosis of pregnancy ‐ not stated
Infection and complication rates (per woman) |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
A pack of cards. |
| 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 |
|
