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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NOT_YET_RECRUITING
NA
164 participants
INTERVENTIONAL
2023-08-01
2026-06-30
Brief Summary
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Women admitted for induction of labor will be recruited and randomized to either a cervical ripening balloon for one hour or twelve hours. the management of delivery after the extraction of the balloon will be left to the discretion of the attending physician.
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Detailed Description
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Study Protocol:
1. Women planned for induction of labor will be approached by a trained resident and will sign informed consent.
2. All participants will be randomized to either one hour or twelve hours CRB placement using a computer program randomization scheme, block size of 20, by the department research coordinator who will keep the sequential in sealed envelopes.
3. Demographic parameters will be retrieved from the computerized database of Rambam Medical Center (RMC).
4. Eligible women will undergo the usual procedure of CRB insertion using a double lumen Cook cervical ripening balloon (CCRB). The CRB will be removed approximately after an hour in the intervention group and after twelve hours in the control group. Thereafter, the women will proceed amniotomy or Pitocin use at the discretion of the labor and delivery physician
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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cervical ripening balloon for 1 hour
Eligible women will undergo the usual procedure of CRB insertion using a double lumen Cook cervical ripening balloon (CCRB). The CRB will be removed approximately after an hour in the intervention group and thereafter, the women will proceed amniotomy or Pitocin use at the discretion of the labor and delivery physician
cervical ripening balloon for one hour
The cervical ripening balloon will be left in place for one hour and after balloon removal the induction of labor will proceed at the discretion of the attending physician at labor and delivery room
cervical ripening balloon for 12 hours
Eligible women will undergo the usual procedure of CRB insertion using a double lumen Cook cervical ripening balloon (CCRB). The CRB will be removed approximately after 12 hours in the control group and thereafter, the women will proceed amniotomy or Pitocin use at the discretion of the labor and delivery physician
cervical ripening balloon for twelve hours
The cervical ripening balloon will be left in place for for twelve hours and after balloon removal the induction of labor will proceed at the discretion of the attending physician at labor and delivery room
Interventions
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cervical ripening balloon for one hour
The cervical ripening balloon will be left in place for one hour and after balloon removal the induction of labor will proceed at the discretion of the attending physician at labor and delivery room
cervical ripening balloon for twelve hours
The cervical ripening balloon will be left in place for for twelve hours and after balloon removal the induction of labor will proceed at the discretion of the attending physician at labor and delivery room
Eligibility Criteria
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Inclusion Criteria
2. Gestational age ≥ 370/7 to 416/7 gestational weeks
3. Age 18-45
4. Signed informed consent
Exclusion Criteria
2. Multifetal gestation
3. Rupture of membranes
4. Bishop score \> 6
5. The cervix is dilated to more than 2 cm
6. Previous caesarean delivery
18 Years
45 Years
FEMALE
Yes
Sponsors
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Rambam Health Care Campus
OTHER
Responsible Party
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Principal Investigators
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Naphtali Justman
Role: PRINCIPAL_INVESTIGATOR
Rambam Health Care Campus
Central Contacts
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Other Identifiers
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0602-21-RMB CTIL
Identifier Type: -
Identifier Source: org_study_id
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