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临床试验/NCT05827731
NCT05827731已完成不适用

Study on the Factors Influencing the Delivery Mode of Pregnant Women Induced by Cervical Double Balloon Combined With Oxytocin

Changsha Hospital for Maternal and Child Health Care1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2021年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
230
试验地点
1
主要终点
Acute Chorioamnionitis

研究概览

简要总结

1 Materials and methods 1.1 Subjects From September 2021 to August 2022, the patients who received induction of labor by cervical double balloon combined with oxytocin in a Grade III A Maternal and Child Health Hospital in Changsha were included in the study. A double balloon and oxytocin induced labor at a tertiary maternal and child health centre in Changsha. Inclusion criteria: 1 age ≥18 years; 2 Singleton; 3 no vaginal infection, fetal membranes intact; 4 according with the indication of induced labor [5] ; These included delayed pregnancy, hypertensive disorder complicating pregnancy, diabetes mellitus, cervical Bishop score < 6, and negative oxytocin provocation test (Oct) . The exclusion criteria were: 1 abnormal head and pelvis, unable to be delivered vaginally; 2 twins; 3 maternal contraindication of vaginal delivery; 4 severe placental dysfunction, unable to tolerate vaginal delivery; 5 there were contraindications for the use of cervical balloon.

1.2 Methods 1.2.1 Operation Method First of all, pregnant women to introduce the procedure of placing the balloon, ease their fear, tension. Assist the patient to take the stone position, sterilize vulva 3 times, spread aseptic towel, expose cervix with vaginal speculum, sterilize vagina and cervix 3 times with iodine cotton ball, after sterilizing the cervical tube 3 times with iodine-complexed cotton swab, insert the disposable dilatation balloon (Henan Bonding Industry Co., Ltd., Yusheng Medical Supervision Machine No. 20180029, model: Type II 18F) into the cervical tube, until the two sacs into the cervical canal and ensure that the double sacs are through the cervical mouth, sub-turn to the cervical inside and outside sacs slowly injected saline 80 ml each. The end of the balloon catheter was fixed to the inner thigh of the pregnant woman with 3m adhesive tape, without restricting the physical activity of the pregnant woman. The operation process is smooth, the pregnant woman has no discomfort, before and after the operation monitoring fetal heart is normal, instructs the pregnant woman to test the fetal movement, closely observes the pregnant woman labor sign and the fetal intrauterine situation. The balloon is usually inserted between 16:00 and 18:00. The balloon is taken out at 8:00 am the next day, oxytocin (Ringe 500ml + oxytocin 2.5 U) was given intravenously to the patients who were not in Labor 1 hour after rupture of membranes. According to the frequency of uterine contractions, if there is no uterine contractions, increase the rate of dripping 8 drops/min, maximum dose not more than 40 drops, until regular uterine contractions, after every half-hour assessment.

1.2.2 Observation indicators Using the hospital electronic medical record information system to search and review the medical records of these women, the age, number of pregnancies, number of parturients, weight gain during pregnancy, height, weight, pre-and post-pregnancy body mass index (BMI) , indication of induced labor, pregnancy complications, gestational age at the time of balloon induced labor, neonatal weight, cervical Bishop score before and after balloon dilatation, occurrence of acute Chorioamnionitis, fetal distress, NST typing, mode of delivery, etc. . The clinical data of the patients who were induced by cervical double balloon combined with oxytocin were analyzed, and the related factors of pregnancy outcome were also discussed.

1.3 Statistical credits SPSS 25.0 was used to analyze the data. The mean ± standard deviation was used for statistical description and t-test was used for statistical analysis. The frequency was used for statistical description and chi-square test was used for statistical analysis. Binary logistic regression analysis was used to determine the influencing factors of different pregnancy modes, and the difference was statistically significant with P < 0.05.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
25 Years 至 34 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •age ≥18 years
  • •Singleton
  • •no vaginal infection, fetal membranes intact
  • •according with the indication of induced labor [5] ; These included delayed pregnancy, hypertensive disorder complicating pregnancy, diabetes mellitus, cervical Bishop score < 6, and negative oxytocin provocation test (Oct)

排除标准

  • •abnormal head and pelvis, unable to be delivered vaginally
  • •maternal contraindication of vaginal delivery
  • •severe placental dysfunction, unable to tolerate vaginal delivery
  • •there were contraindications for the use of cervical balloon.

研究组 & 干预措施

Natural delivery group

No Intervention

The patients in this group were treated with natural delivery

Cesarean section group

Experimental

The patients in this group were delivered by cesarean section

干预措施: cesarean section (Behavioral)

结局指标

主要结局

Acute Chorioamnionitis

时间窗: Immediately after the surgery

acute Chorioamnionitis (or = 0.006,95% cl = 0.001-0.030, p \< 0.001)

NST typing

时间窗: Immediately after the surgery

NST typing (or = 20.057,95% CL = 4.145-97.039, p \< 0.001)

Fetal distress

时间窗: Immediately after the surgery

fetal distress (or = 0.102,95% CL = 0.022-0.473, P = 0.004)

次要结局

未报告次要终点

研究者

发起方
Changsha Hospital for Maternal and Child Health Care
申办方类型
Other
责任方
Principal Investigator
主要研究者

Qiu-Hong Xiang

Principal investigator

Changsha Hospital for Maternal and Child Health Care

研究点 (1)

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