METHODS: We conducted a multicentre randomised controlled study of 420 patients from 1st January 2016 to 31st December 2017 to evaluate the use of DBC in IOL in an Asian population looking at the adverse effects in the first 12 h after insertion. Women were assigned randomly to cervical ripening with either a DBC or a prostaglandin pessary. The adverse events in the 12 h after DBC or first prostaglandin inserted, the efficacy of a DBC to a prostaglandin in labour induction and maternal satisfaction were evaluated.
RESULTS: There were significantly less women with uterine hyperstimulation in the DBC (2 vs 24, p ≤ 0.0001) compared to the prostaglandin group. There were no women with uterine hyperstimulation and non-reassuring foetal status in the DBC while there were 5 women with uterine hyperstimulation and foetal distress in the prostaglandin group. Use of entonox was significantly less in the DBC group (p = 0.009). There were no significant differences in both groups in caesarean section, vaginal deliveries and time to delivery, although significant less time was needed to achieve cervical os dilation more than 4 cm in the DBC group (p ≤ 0.0001). Neonatal birth outcomes were similar. Women's pain scores were similar for both methods. 80.1% of women allocated the DBC and 76.8% of women allocated the PGE were keen to recommend their method of induction.
CONCLUSION: Double balloon catheter remains a good alternative method for inducing women in view of a good safety profile with low risk of hyperstimulation and high maternal satisfaction.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02620215.
SETTING: Department of Ophthalmology, Penang General Hospital, Georgetown Penang, Malaysia.
DESIGN: Prospective comparative case series.
METHOD: Patients with immature cataract were randomized to the topical mydriatic group (topical group) or intracameral mydriatic group (intracameral group). Patients with small pupils and complicated cataracts were excluded. Pupil diameter changes were measured throughout the surgery. Additional pupil dilation maneuvers and complications were recorded.
RESULTS: The study comprised 112 patients. There was no difference in mean pupil dilation between the intracameral group (4.86 mm ± 0.74 [SD]) and the topical group (4.88 ± 0.91 mm) (P = .86). However, the mean pupil size before capsulorhexis in the topical group (7.23 ± 1.08 mm) was significantly larger than in the intracameral group (6.40 ± 0.80 mm) (P = .01). The pupils in the intracameral group continued to dilate during surgery (0.44 ± 0.62 mm), while those in the topical group constricted (-0.41 ± 1.04 mm) (P