Rabinovici 1987.
| Methods | 'Randomized control trial.' | |
| Participants | Inclusion criteria: twin pregnancy, induced or spontaneous labour, both alive. 1st vertex, 2nd breech or transverse, 35‐42 weeks estimated gestational age, no known fetal anomaly, no signs of acute placental insufficiency or abruption, normal amniotic fluid volume, normal FHR testing, no maternal or obstetric indications for a specific route of delivery, cervix < 7 cm dilated. 60 women randomised. | |
| Interventions | Experimental intervention: planned lower segment CS, preferably with epidural analgesia, but dependent on preference of anaesthetist. Control/comparison intervention: planned VB following evaluation of labour progress using ‘Friedman curve’; continuous electronic fetal monitoring of both babies; lie of 2nd twin confirmed clinically or with ultrasound; if breech, assisted breech delivery planned; of fetal distress or poor progress despite oxytocin, total breech extraction done; artificial rupture of second sac as late as possible; if second twin in oblique or transverse lie, internal version and complete breech extraction under general analgesia or epidural analgesia if in place; routine episiotomy. |
|
| Outcomes | Method of delivery; birthweight, Apgar scores, neonatal and maternal complications. | |
| Notes | Setting: Chaim Sheba Medical Centre labour ward. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Allocation “changed randomly by a non‐involved person without prior notice on a time basis”. 20% difference in group sizes not accounted for (27 vs 33). |
| Allocation concealment (selection bias) | High risk | See above. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding not feasible. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not mentioned whether neonatal assessments blinded. |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 6 women allocated to planned VB excluded from primary analysis for delivery not according to protocol (2 CS and 4 vertex VBs). Analysis was not conducted on an ITT basis. Only categorical neonatal data have been included in the review as data given separately for the 6 excluded women and could be added to the primary data, thus low risk of bias for these outcomes. |
| Selective reporting (reporting bias) | Unclear risk | No pre‐published protocol available to check predefined outcome reporting. |
| Other bias | High risk | Baseline imbalance: CS n = 27 vs vaginal n = 33. |
CS: caesarean section FHR: fetal heart rate ITT: intention‐to‐treat VB: vaginal birth vs: versus