Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05827731
Other study ID # ChangshaHMC 331
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date October 31, 2022

Study information

Verified date April 2023
Source Changsha Hospital for Maternal and Child Health Care
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 230
Est. completion date October 31, 2022
Est. primary completion date August 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 25 Years to 34 Years
Eligibility Inclusion Criteria: - 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) Exclusion Criteria: - abnormal head and pelvis, unable to be delivered vaginally - twins - maternal contraindication of vaginal delivery - severe placental dysfunction, unable to tolerate vaginal delivery - there were contraindications for the use of cervical balloon.

Study Design


Intervention

Behavioral:
cesarean section
According to the different outcomes of pregnancy, the patients were divided into natural delivery group and cesarean section group

Locations

Country Name City State
China Changsha Hospital for Maternal & Child Health Care Affiliated to Hunan Normal University Changsha Hunan

Sponsors (1)

Lead Sponsor Collaborator
Changsha Hospital for Maternal and Child Health Care

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Acute Chorioamnionitis acute Chorioamnionitis (or = 0.006,95% cl = 0.001-0.030, p < 0.001) Immediately after the surgery
Primary Fetal distress fetal distress (or = 0.102,95% CL = 0.022-0.473, P = 0.004) Immediately after the surgery
Primary NST typing NST typing (or = 20.057,95% CL = 4.145-97.039, p < 0.001) Immediately after the surgery
See also
  Status Clinical Trial Phase
Completed NCT02566356 - Adult Study Oxytocin - fMRI Early Phase 1
Completed NCT04330677 - Dissecting the Role of Estradiol in Mediating Gender-specific Anxiolytic and Prosocial Effects of Oxytocin Phase 1
Completed NCT02567032 - Adult Study Oxytocin - Behavioral Early Phase 1
Recruiting NCT04760496 - Effect of Increased Oxytocin Doses on the Mode of Delivery in Obese Primiparous Women With Spontaneous or Induced Labour Phase 4
Completed NCT03096249 - The Influence of Oxytocin on Socio-communicative Sensitivity Phase 1/Phase 2
Recruiting NCT05079841 - The Stimulation To Induce Mothers Study Phase 4
Completed NCT05059028 - Effect of Oxytocin Massage and Music on Breastfeeding N/A
Enrolling by invitation NCT06403982 - The Influence of Oxytocin on Intrapartum Fetal Well-being and Delivery Outcomes in Patients Receiving Epidural Analgesia N/A
Completed NCT03140709 - Non-Invasive, Highly Specific Detection of Oxytocin in Biological Fluids N/A
Recruiting NCT04109339 - Effects of Oxytocin on Hemodynamics in Patients Undergoing Laparoscopic Myomectomy N/A
Completed NCT01891201 - Intrapartum Oxytocin Administration Affects Primitive Neonatal Reflexes N/A
Completed NCT05357521 - Interplay Between Oxytocin and Cortisol During Stress in Borderline Personality Disorder
Completed NCT03140488 - Oxytocin Dosage to Decrease Induction Duration Phase 4
Completed NCT05823441 - Effect of Oxytocin Nasal Inhalation on Empathy Analgesia Phase 4
Not yet recruiting NCT06010368 - Comparing Intramyometrial Tranexamic Acid and Oxytocin for Blood Loss in Cesarean Section Phase 3
Withdrawn NCT05608070 - IV Oxytocin for Post Operative Pain After Minimally Invasive Hysterectomy Phase 4
Completed NCT04441125 - The Effect of Labor Induction With Oxytocin on Early Postpartum Hemorrhage, Perineal Integrity and Breastfeeding
Recruiting NCT04551482 - Oxytocin for Weight Loss in Adolescents Phase 2
Completed NCT03255148 - Influence of Oxytocin on Resting State Neurophysiological Measures Phase 1
Completed NCT03272321 - Influence of Oxytocin on Neurophysiological Responses to Live Faces Phase 1/Phase 2