Marquette 1996.
Methods | RCT. | |
Participants |
Inclusion criteria: women with singleton breech presentation, 36 to 41 weeks' gestation, reactive CTG, breech mobile on abdominal palpation. N = 283. Exclusion criteria: impaired fetal growth (estimated weight < 10th percentile), oligohydramnios (AFI < 5), placenta praevia, placental abruption, uterine scar other than low transverse CS, active labour, ruptured membranes, fetal anomalies incompatible with life, contraindication to vaginal delivery, contraindication to tocolysis. |
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Interventions |
Intervention:tocolytic: ritodrine ‐ beta stimulant (A1) ‐ parenteral. IVI, for 20 minutes before and during ECV attempt, of ritodrine 111 micrograms/min or placebo. Maximum of 3 ECV attempts as forward or backward flip. CTG was repeated. N = 138. Comparison:placebo. N = 145 |
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Outcomes | Duration of infusion (tocolysis mean 32.1 (SD 1.04) vs control 31.7 (1.12) minutes); unsuccessful ECV; CTG results (all reactive); time from ECV to birth (average 2 weeks); maternal and fetal complications (maternal complications < 4%, similar between groups); mode of birth; birthweight (3370 (39) vs 3382 (44) grams). | |
Notes | Groups differed in terms of frank breech (tocolysis 59/138 vs control 43/145) and nulliparity (58/138 vs 49/145). Parity (nulliparous 34% vs parous 61%), but not type of breech, affected ECV success rate; therefore results controlled for parity. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | States random assignment of every 10 patients enrolled: 5 to ritodrine and 5 to control. |
Allocation concealment (selection bias) | Unclear risk | No information provided. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Placebo and treatment made up in pharmacy in identical phials and administered IV in the same solution at the same rate. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Placebo and treatment made up in pharmacy in identical phials and administered IV in the same solution at the same rate. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No exclusions or loss to follow‐up reported. |
Selective reporting (reporting bias) | Unclear risk | We did not assess the trial protocol. |
Other bias | Unclear risk | Ritodrine group had higher proportion of nulliparous women. It is unclear whether this would impact the comparison of outcomes. |