Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2018-03-01
2021-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
All eligible women will be presented with the study protocol by a study coordinator.The following screening medical procedures will be completed:
Medical and gynecological history, physical and vaginal speculum examination, Ultrasonography and a non-stress test (NST).
For eligible patients, and following an informed consent, group randomization will take place:
GROUP 1: Expectant management (standard protocol). GROUP 2: Insertion of a balloon cervical catheter (study group).
The randomization process will be as follows:
A. The eligible patient will sign the informed consent prior to randomization. B. The patient will receive a subject number for the study (from 1 to 200) The study coordinator will open a sealed envelope with the patient's study number to reveal the patient's assigned study group.
TREATMENT
NONE
Study Groups
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Double balloon catheter for induction of labor
in this group a trans-cervical double balloon catheter will be inserted. Following device insertion, 20 minutes of external monitoring is performed. The patient will be transferred to the Ob/Gyn ward for hospitalization. 12 hours after insertion of the device the balloons are deflated and the device removed. At this stage the patient is assessed for a second Bishop score and expectant management is resuming.
Double Balloon catheter for induction of labor
With the patient in lithotomy position or lying supine in bed, a speculum is inserted to visualise the cervix. The device is inserted into the cervix using long forceps until both balloons enter the cervical canal. Then, the uterine balloon is inflated with 20 ml of saline (by means of a 20 ml syringe). The device is then pulled out until stopped by the uterine balloon covering the internal cervical os. At this point the cervico-vaginal balloon located at the external os is inflated with 20 ml of saline and the speculum is removed. Then both balloons are additionally inflated with alternate increments of 20 ml normal saline to a total volume of 80 ml in each balloon. The device is loosely taped to the patient's inner thigh.
Expectant management
Women in the expectant management group will be transferred to the Ob/Gyn ward for hospitalization and conservative management until spontaneous labor ensues.
No interventions assigned to this group
Interventions
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Double Balloon catheter for induction of labor
With the patient in lithotomy position or lying supine in bed, a speculum is inserted to visualise the cervix. The device is inserted into the cervix using long forceps until both balloons enter the cervical canal. Then, the uterine balloon is inflated with 20 ml of saline (by means of a 20 ml syringe). The device is then pulled out until stopped by the uterine balloon covering the internal cervical os. At this point the cervico-vaginal balloon located at the external os is inflated with 20 ml of saline and the speculum is removed. Then both balloons are additionally inflated with alternate increments of 20 ml normal saline to a total volume of 80 ml in each balloon. The device is loosely taped to the patient's inner thigh.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Singleton Pregnancy
2. Previous single cesarean section
3. At least 12 months have elapsed since the previous caesarean delivery
4. Diagnosed with confirmed PROM at ≥ 34 weeks' gestation.
5. Ruptured membranes have occurred ≤24 hours prior to inclusion in the study.
6. Vertex presentation well applied to the cervix
7. Found to have an unripe cervix in a speculum examination (Bishop score ≤6).
8. Absence of significant and regular uterine contraction (\<3/10Min).
9. Willingness to comply with the protocol for the duration of the study.
10. Have signed an informed consent (including a TOLAC consent form).
Exclusion Criteria
1. Any contraindication for a vaginal delivery (i.e. placenta previa, non-vertex presentation, previous cesarean delivery \< 12 months).
2. Regular uterine contractions (\>3/10Min).
3. Diagnosis of ruptured membranes was made over 24 hours prior to study inclusion.
4. Meconium stained amniotic fluid.
5. Evidence of chorio-amnionitis (T 37.6°C with uterine tenderness and maternal or fetal tachycardia or purulent discharge or WBC20.000)
6. Suspected placental abruption or a significant hemorrhage.
7. Non-reassuring fetal status (as determined by fetal heart rate monitoring and/or bio-physical profile) necessitating immediate intervention.
18 Years
45 Years
FEMALE
Yes
Sponsors
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Soroka University Medical Center
OTHER
Responsible Party
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Gil Gutvirtz MD
Ob/Gyn Resident
Locations
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Soroka University Medical Center
Beersheba, , Israel
Countries
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Central Contacts
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Facility Contacts
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References
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de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
Other Identifiers
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SOR-0019-17-CTIL
Identifier Type: -
Identifier Source: org_study_id
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