Cervical Double Balloon Combined With Oxytocin
Condition: Pregnancy Outcomes; Oxytocin; Labor Induction; Mode of Delivery
Study type: Interventional

Summary: 
      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.
    


Intervention name(s): cesarean section
Intervention type(s): Behavioral
Intervention description(s): According to the different outcomes of pregnancy, the patients were divided into natural delivery group and cesarean section group
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care