PDF(Pubmed)
Abstract：
UNASSIGNED: To compare cervical ripening time with the use of vaginal Misoprostol plus Hyoscine-N-Butylbromide, with vaginal Misoprostol alone.
UNASSIGNED: A double-blind randomized controlled trial with Pan-African Clinical Trials Registry (PACTR) approval number PACTR202112821475292.
UNASSIGNED: Federal Medical Centre, Asaba, Nigeria.
UNASSIGNED: A total of 126 eligible antenatal patients for cervical ripening were enrolled.
UNASSIGNED: Participants in Group A had 25µg of vaginal misoprostol with 1ml of intramuscular placebo, and those in Group B had 25µg of vaginal misoprostol with 20mg of Intramuscular Hyoscine (1 ml). Oxytocin infusion was used when indicated, and the labour was supervised as per departmental protocol.
UNASSIGNED: Cervical ripening time.
UNASSIGNED: The mean cervical ripening time was statistically significantly shorter in the hyoscine group (8.48±4.36 hours) than in the placebo group (11.40±7.33 hours); p-value 0.02, 95% CI 0.80-5.05. There was no statistically significant difference in the mean induction-delivery interval in Group A (7.38±5.28 hours) compared to Group B (7.75±5.04 hours), with a value of 0.54. The mode of delivery was comparable. However, women in Group B (53, 84.1%) achieved more vaginal deliveries than women in Group A (50, 79.4%); p-value 0.49. Thirteen women in Group A (20.6%) had a caesarean section, while ten women (15.9%) in Group B had a caesarean section (p-value 0.49, RR 0.94, CI 0.80-1.11). Adverse maternal and neonatal outcomes were not statistically significant between the two groups.
UNASSIGNED: Intramuscular hyoscine was effective in reducing cervical ripening time when used as an adjunct to vaginal Misoprostol, with no significant adverse maternal or neonatal outcome.
UNASSIGNED: None declared.
UNASSIGNED: A double-blind randomized controlled trial with Pan-African Clinical Trials Registry (PACTR) approval number PACTR202112821475292.
UNASSIGNED: Federal Medical Centre, Asaba, Nigeria.
UNASSIGNED: A total of 126 eligible antenatal patients for cervical ripening were enrolled.
UNASSIGNED: Participants in Group A had 25µg of vaginal misoprostol with 1ml of intramuscular placebo, and those in Group B had 25µg of vaginal misoprostol with 20mg of Intramuscular Hyoscine (1 ml). Oxytocin infusion was used when indicated, and the labour was supervised as per departmental protocol.
UNASSIGNED: Cervical ripening time.
UNASSIGNED: The mean cervical ripening time was statistically significantly shorter in the hyoscine group (8.48±4.36 hours) than in the placebo group (11.40±7.33 hours); p-value 0.02, 95% CI 0.80-5.05. There was no statistically significant difference in the mean induction-delivery interval in Group A (7.38±5.28 hours) compared to Group B (7.75±5.04 hours), with a value of 0.54. The mode of delivery was comparable. However, women in Group B (53, 84.1%) achieved more vaginal deliveries than women in Group A (50, 79.4%); p-value 0.49. Thirteen women in Group A (20.6%) had a caesarean section, while ten women (15.9%) in Group B had a caesarean section (p-value 0.49, RR 0.94, CI 0.80-1.11). Adverse maternal and neonatal outcomes were not statistically significant between the two groups.
UNASSIGNED: Intramuscular hyoscine was effective in reducing cervical ripening time when used as an adjunct to vaginal Misoprostol, with no significant adverse maternal or neonatal outcome.
UNASSIGNED: None declared.
摘要：
■为了比较宫颈成熟时间与使用阴道米索前列醇加Hyoscine-N-丁基溴，单独使用米索前列醇阴道。
■一项双盲随机对照试验，泛非临床试验注册（PACTR）批准号为PACTR202112821475292。
■联邦医疗中心，Asaba,尼日利亚。
■共纳入126名符合产前宫颈成熟的患者。
■A组的参与者有25微克阴道米索前列醇和1毫升肌内安慰剂，B组中的患者有25µg阴道米索前列醇和20mg肌内Hyoscine（1ml）。当需要时使用催产素输注，劳动按照部门协议进行监督。
■宫颈成熟时间。
■hyoscine组的平均宫颈成熟时间（8.48±4.36小时）明显短于安慰剂组（11.40±7.33小时）；p值0.02，95%CI0.80-5.05。A组(7.38±5.28小时)平均诱导-分娩间期与B组(7.75±5.04小时)比较,差异无统计学意义,值为0.54。交付方式具有可比性。然而,B组女性(53,84.1%)的阴道分娩率高于A组女性(50,79.4%);p值0.49.甲组13名妇女(20.6%)剖腹产,B组中有10名妇女（15.9％）进行了剖腹产（p值0.49，RR0.94，CI0.80-1.11）。两组间不良母婴结局无统计学意义。
■当用作阴道米索前列醇的辅助药物时，肌内hyoscine可有效减少宫颈成熟时间，没有明显的不良母婴结局。
■没有声明。
■一项双盲随机对照试验，泛非临床试验注册（PACTR）批准号为PACTR202112821475292。
■联邦医疗中心，Asaba,尼日利亚。
■共纳入126名符合产前宫颈成熟的患者。
■A组的参与者有25微克阴道米索前列醇和1毫升肌内安慰剂，B组中的患者有25µg阴道米索前列醇和20mg肌内Hyoscine（1ml）。当需要时使用催产素输注，劳动按照部门协议进行监督。
■宫颈成熟时间。
■hyoscine组的平均宫颈成熟时间（8.48±4.36小时）明显短于安慰剂组（11.40±7.33小时）；p值0.02，95%CI0.80-5.05。A组(7.38±5.28小时)平均诱导-分娩间期与B组(7.75±5.04小时)比较,差异无统计学意义,值为0.54。交付方式具有可比性。然而,B组女性(53,84.1%)的阴道分娩率高于A组女性(50,79.4%);p值0.49.甲组13名妇女(20.6%)剖腹产,B组中有10名妇女（15.9％）进行了剖腹产（p值0.49，RR0.94，CI0.80-1.11）。两组间不良母婴结局无统计学意义。
■当用作阴道米索前列醇的辅助药物时，肌内hyoscine可有效减少宫颈成熟时间，没有明显的不良母婴结局。
■没有声明。
