An interventional study of Dinoprostone and Cervical ripening balloon. in Induction of Labor Affected Fetus / Newborn, sponsored by Rambam Health Care Campus. Completed at 1 site in Israel. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2022-04-20.
Sponsored by Rambam Health Care Campus · Not applicable, Interventional, and Treatment
Women after induction of labor with a dinoprostone insert will be evaluated after 24 hours from the beginning of labor induction. Women with a BISHOP score of less than 5 will be randomized to 1 of 2 groups. Induction with a cervical ripening balloon versus induction with a 2nd dinoprostone insert.
Nulliparous women with obstetric indications for induction of labor who were induced with a dinoprostone insert and failed to go into labor after 24 hours from the beginning of labor induction and a BISHOP score of less than 5 will receive a thorough explanation regarding the study and sign informed consent. The eligible women will be randomized to 1 of 2 groups. Induction with a cervical ripening balloon versus induction with a 2nd dinoprostone insert. Relevant demographic and medical information will be gathered from the patients' electronic files.
Rambam Health Care Campus is the lead sponsor of 466 studies on the registry; 34 are open to participants now.
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Exclusion Criteria:
Women induced with a second dinoprostone insert.
Drug: Dinoprostone
Women induced with a cervical ripening balloon.
Device: Cervical ripening balloon.
Dinoprostone vaginal insert.
Double lumen cervical ripening balloon.
Delivery within 24 hours.
Rate of delivery in 24 hours.
Time frame: From the time of induction up to 24 hours from induction.
Time to delivery.
The number of hours it takes to deliver.
Time frame: From the time of induction up to 120 hours from induction.
Mode of delivery.
Vaginal and cesarean delivery rates.
Time frame: From the time of induction up to 120 hours from induction.
Uterine revision.
The rate of uterine revision postpartum.
Time frame: From the time of induction up to 120 hours from induction.
Postpartum hemorrhage.
The rate of postpartum hemorrhage.
Time frame: From the time of induction up to 120 hours from induction.
Chorioamnionitis.
The rate of chorioamnionitis.
Time frame: From the time of induction up to 120 hours from induction.
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2020 to primary completion in Nov 2021, 13 months.
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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dinoprostone