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The study is intended to compare expectant management and on presentation labor induction in women with premature rupture of membranes.
The means of labor induction and cervical ripening are either oxytocin or dinoprostone.
Expectant management in this obstetrical state means waiting 24 hours from the onset of rupture of membranes and then commencing labor induction with either oxytocin or dinoprostone depending on the patient's obstetrical history and cervical condition.
The investigators' hypothesis is that active management will lead to a higher rate of vaginal deliveries, a shorter interval between the time of rupture of membranes and the time of delivery, a lower rate of cesarean sections and a better obstetric result for the mother and the fetus/newborn.
In the setting of premature rupture of membranes in term pregnancies, it is customary in women who are not in active labor to wait for 24 hours before attempting to induce labor. The means of labor induction used at our medical center are either intravenous oxytocin or per-vaginal dinoprostone, depending on patient's obstetric history and cervical conditions.
The investigators hypothesize that commencing induction of labor at presentation in these women by either means of induction will lead to higher rates of vaginal delivery, shorter intervals between the time of onset of rupture of membranes and the time of delivery and lower rates of cesarean sections.
The participants in the study, upon signing informed consents, will be randomized to 4 groups-2 groups of expectant management in which labor induction will be commenced after 24 hours with either oxytocin or dinoprostone and 2 groups of active management in which labor induction will be commenced at presentation with either oxytocin or dinoprostone.
The participants will be followed from the time of presentation with rupture of membranes at the delivery room and until the time of delivery.
Further obstetric, clinical and demographic information will be acquired from the patient's electronic medical file for analysis accuracy and sub-analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Expectant Management-Dinoprostone | Active Comparator | Women with premature rupture of membranes who are not in active labor and have an unfavorable cervix (Bishop score<6). Labor induction will be initiated with Dinoprostone after 24 hours of waiting depending on obstetric history and cervical conditions. |
|
| Expectant Management-Oxytocin | Active Comparator | Women with premature rupture of membranes who are not in active labor and have an unfavorable cervix (Bishop score<6). Labor induction will be initiated with oxytocin after 24 hours of waiting depending on obstetric history and cervical conditions. |
|
| Active Management-Dinoprostone | Experimental | Women with premature rupture of membranes who are not in active labor and have an unfavorable cervix (Bishop score<6). Labor induction will be initiated with Dinoprostone on presentation depending on obstetric history and cervical conditions. |
|
| Active Management-Oxytocin | Experimental | Women with premature rupture of membranes who are not in active labor and have an unfavorable cervix (Bishop score<6). Labor induction will be initiated with oxytocin on presentation depending on obstetric history and cervical conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug | Labor induction and cervical ripening by oxytocin in women with premature rupture of membranes in 2 types of women:
|
| Measure | Description | Time Frame |
|---|---|---|
| Vaginal delivery rate | The percentage of participants that achieved vaginal delivery | Up to 7 days from the time of presentation with rupture of membranes |
| Measure | Description | Time Frame |
|---|---|---|
| Interval to delivery | Interval from the time of onset of premature rupture of membranes and the time of delivery (In minutes) | Up to 7 days from the time of presentation with rupture of membranes |
| Caesarian delivery rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amir Weissman, MD | Rambam Health Care Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam health care campus | Haifa | Israel |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| D015232 | Dinoprostone |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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|
| Dinoprostone | Drug | Labor induction and cervical ripening by dinoprostone in women with premature rupture of membranes in 2 types of women:
|
|
|
The percentage of participants that required caesarian delivery
| Up to 7 days from the time of presentation with rupture of membranes |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011458 | Prostaglandins E |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |