An interventional study of Double Balloon catheter for induction of labor in Previous; Cesarean Section, Cicatricial, Complicating Pregnancy or Childbirth, Affecting Fetus or Newborn and Prelabor Rupture of Membranes, sponsored by Soroka University Medical Center. Status unknown at 1 site in Israel. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-14.
Sponsored by Soroka University Medical Center · Not applicable, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 12 studies in Pregnancy Complications with a site in Israel — 3 open to participants now, 3 under way, none of them phase 3. Pregnancy Complications · Israel.
Among the 12 studies in Pregnancy Complications with a site in Israel, this one is the only one that started in 2018, is one of 5 with no phase, and was the 6th registered.
411 studies on the registry are indexed under Pregnancy Complications; 113 are open to participants now.
Browse Pregnancy Complications studies →3 of the 12 studies in Pregnancy Complications with a site in Israel are open now. Recruiting first, the newest first:
University Hospital, Basel, Switzerland · Sites in Israel, United States, Argentina and 6 more countries
Ages 18+ · Women only
Tel-Aviv Sourasky Medical Center · Sites in Israel
Women only
Wolfson Medical Center · Sites in Israel
Ages 18+ · Women only
A study can be open while its sites in Israel have not opened yet or have stopped. Only those recruiting at a site in Israel →
Of the 92 Pregnancy Complications studies recruiting now, 44 (48%) set no upper age limit and 45 (49%) stop at 75 or younger; 22 take children under 18; 35 take healthy volunteers.
This study: 18 Years to 45 Years · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
First in 1997; this study’s year is marked. 1 started in 2018.
This study's planned enrollment of 200 is above the median of 144 across 205 interventional studies indexed under Pregnancy Complications.
Median enrollment 200 across the 5 interventional studies, 320 across the 7 observational. Of the 2 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 12 has an industry lead sponsor. The 10 most frequent:
Soroka University Medical Center is the lead sponsor of 160 studies on the registry; 2 are open to participants now.
Soroka University Medical Center has 1 study filed under Pregnancy Complications — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 12 studies in Pregnancy Complications with a site in Israel, from their registry updates:
This tab as a report to print or save as PDF → With an account.
A prospective randomized controlled trial to evaluate the safety and efficacy of labor induction with a double balloon catheter (Atad Ripener Device) in women desiring TOLAC (trial of labor after cesarean) with PROM (pre labor rupture of membranes).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Only patients who meet the following criteria will be approached.
Exclusion Criteria:
Patients having any of the following conditions will be excluded from the study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Double Balloon catheter for induction of labor
Women in the expectant management group will be transferred to the Ob/Gyn ward for hospitalization and conservative management until spontaneous labor ensues.
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.
Also known as: Atad Ripener Device
Vaginal birth after cesarean (VBAC) rates
Time frame: 5 days
PROM to delivery interval (time)
Time frame: 5 days
intrapartum and post-partum infection rates
Time frame: 5 days
Cesarean section rates
Time frame: 5 days
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2018 (actual). Primary completion is estimated for Mar 2020, 24 months after the start.
Of 119 non-industry interventional studies with no phase under Pregnancy Complications, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 24 months is close to that.
Counting every sponsor, half of 119 studies reached it within 26 months; a quarter within 12 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Soroka University Medical Center →