Department of Obstetrics, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing Maternal and Child Health Care Hospital, No.251 Yaojiayuan Road, Beijing, 100026, China.
BMC Pregnancy Childbirth. 2023 Oct 23;23(1):746. doi: 10.1186/s12884-023-06004-7.
The rate of caesarean section (CS) is increasing worldwide. While a CS can be life-saving when medically indicated, it can cause adverse health effects for both women and children. This trial aims to evaluate the effect of the smartphone application, which aims to control the gestational weight gain, on the rate of CS in overweight and obese women.
Overweight and obese primiparas (BMI ≥ 24 kg/m) with age between 20 and 40 years old were recruited at Beijing Obstetrics and Gynecology Hospital, and randomly assigned into the intervention group (143 cases) and the control group (138 cases). The intervention group applied the smartphone application (App) to control gestational weight gain in addition to the usual care, and the control group received the usual care. Primary outcome was cesarean section (CS) rate. Secondary outcomes included gestational hypertension, preeclampsia and eclampsia, gestational diabetes mellitus, postpartum hemorrhage, neonatal asphyxia, and macrosomia.
There was a significant difference in CS rate, with 53.3% in the intervention group and 65.4% in the control group (P = 0.044). The difference still exists in the overweight subgroup (32.6% vs. 55.6%, P = 0.04), but disappears in the obesity subgroup (63.0% vs. 69.1%, P = 0.381). The median of gestational weight gain (GWG) of the intervention group is 8.5 kg (IQR 5.5, 11.0), which is significantly less than that of the control group (median 10.0 kg, IQR [6.0, 14.0], P = 0.008). The intervention group has significantly lower rate of postpartum hemorrhage (5.19%) than the control group (12%) (P = 0.045). There were no significant differences between the groups in gestational hypertension, gestational diabetes mellitus, neonatal asphyxia, and macrosomia.
The smartphone assisted weight control may help reduce CS rate. The effects of the smartphone application might be via the management of gestational weight gain.
This trial was registered at Chinese Clinical Trial Registry. Registration number is ChiCTR2300068845 (retrospectively registered, 01/03/2023).
剖宫产率在全球范围内呈上升趋势。虽然剖宫产在医学上是救命的，但它会对妇女和儿童的健康产生不良影响。本试验旨在评估旨在控制妊娠期体重增加的智能手机应用程序对超重和肥胖妇女剖宫产率的影响。
在北京妇产医院招募年龄在 20 至 40 岁之间的超重和肥胖初产妇（BMI≥24kg/m），并随机分为干预组（143 例）和对照组（138 例）。干预组除常规护理外，还应用智能手机应用程序（App）控制妊娠期体重增加，对照组仅接受常规护理。主要结局为剖宫产率。次要结局包括妊娠期高血压、子痫前期和子痫、妊娠期糖尿病、产后出血、新生儿窒息和巨大儿。
剖宫产率有显著差异，干预组为 53.3%，对照组为 65.4%（P=0.044）。超重亚组（32.6% vs. 55.6%，P=0.04）差异仍然存在，但肥胖亚组（63.0% vs. 69.1%，P=0.381）差异消失。干预组的妊娠期体重增加（GWG）中位数为 8.5kg（IQR 5.5，11.0），明显低于对照组（中位数 10.0kg，IQR [6.0，14.0]，P=0.008）。干预组产后出血率（5.19%）明显低于对照组（12%）（P=0.045）。两组在妊娠期高血压、妊娠期糖尿病、新生儿窒息和巨大儿方面无显著差异。
智能手机辅助体重控制可能有助于降低剖宫产率。智能手机应用的效果可能是通过管理妊娠期体重增加来实现的。
本试验在中国临床试验注册中心注册。注册号为 ChiCTR2300068845（回顾性注册，2023 年 01 月 03 日）。
