Wang 2014.
Methods | RCT | |
Participants | Inclusion: oligohydramnios (AFI < 5 cm). GA beyond 37 0/7 weeks’, singleton pregnancy, vertex presentation, BS ≤ 6, intact membranes, the absence of documented uterine contractions, the absence of prior CS delivery, reassuring antenatal fetal testing (non‐stress test) active, and oxytocin challenge test negative upon study entry. Exclusion: antepartum bleeding, chorioamnionitis, placenta previa, or any other contraindication to vaginal delivery, women with documented PG allergy, maternal asthma history, vaginitis or cervicitis at presentation, and/or glaucoma history were not eligible for the pharmacological treatment arm |
|
Interventions | Double balloon (n = 67): 80/80cc, no traction, max 12 hours. After 24 hours unsuccessful ripening start oxytocin 10 mg dinoprostone insert (n = 59), fornix posterior, max 24 hours, After 24 hours unsuccessful ripening start oxytocin |
|
Outcomes | Pregnancy outcomes and success of induction | |
Notes | Setting: The People’s Liberation Army 174th Hospital, Xiamen, China, Study period: April 2010 ‐ February 2011 Funding: financial support of The People’s Liberation Army Nanjing Military Area Command Medicine Health Department in China. Declarations of interest: none declared |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described how random sequence was generated. |
Allocation concealment (selection bias) | Low risk | Sealed envelope randomisation, opaque? |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not feasible due to nature of intervention |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | High risk | No ITT => 5 woman reassigned after randomisation (non re‐assuring FHR, failed placement) no missing data or cases |
Selective reporting (reporting bias) | Unclear risk | No pre specified outcomes reported, so can't be judged |
Other bias | Low risk | No other bias detected |