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Pregnancy OutcomesNCT05827731

Cervical Double Balloon Combined With Oxytocin

A study testing cesarean section in people with Pregnancy Outcomes and Oxytocin, run by Changsha Hospital for Maternal and Child Health Care at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 25 to 34 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy Outcomes, Oxytocin, Labor Induction
What is being tested?
cesarean section
Could I receive a placebo?
No, everyone receives an active treatment
How many people
230 participants
Where
1 siteChina
Study dates
1 Sep 2021to 31 Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 34 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Changsha Hospital for Maternal & Child Health Care Affiliated to Hunan Normal University

    Changsha, Hunan, 410007

Other trials in China

About this study

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

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.

Read more

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.

Being tested
cesarean section

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cesarean sectionBehavioural

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

Study groups in NCT05827731
Study groupRoleWhat they receive
Natural delivery groupNo interventionThe patients in this group were treated with natural delivery
Cesarean section groupExperimentalThe patients in this group were delivered by cesarean section
Receives: Behavioral: cesarean section

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acute Chorioamnionitis

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

    Measured: Immediately after the surgery

  2. Fetal distress

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

    Measured: Immediately after the surgery

  3. NST typing

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

    Measured: Immediately after the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2023
  2. Study start1 Sep 2021
  3. Primary completion31 Aug 2022
  4. Study completion31 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
230 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05827731
Sponsor's protocol ID
ChangshaHMC 331
Status last verified
Apr 2023
First submitted
5 Apr 2023
Last updated
25 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing cesarean section in people with Pregnancy Outcomes and Oxytocin, run by Changsha Hospital for Maternal and Child Health Care at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute Chorioamnionitis (time frame: Immediately after the surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.

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