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Women with a BMI>30 and women with a BMI<30 will be divided in a randomized controlled manor to 4 groups depending on the mode of labor induction and BMI value:
The study is a randomized controlled test in which women with a BMI>30 and women with a BMI<30 will sign an informed consent and then divided to 4 groups depending on the mode of labor induction and BMI value:
The subjects will be followed until labor, and information regarding the success of induction, mode of delivery and time of delivery will be collected from patients' electronic files.
The participants will finish participation in the study after delivery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMI>30+Dinoprostone | Experimental | Women with a BMI>30 at term that will be induced for obstetrical indications with 10 mg of a Dinoprostone vaginal insert. |
|
| BMI<30+Dinoprostone | Experimental | Women with a BMI<30 at term that will be induced for obstetrical indications with 10 mg of a Dinoprostone vaginal insert. |
|
| BMI>30+Cervical ripening balloon | Experimental | Women with a BMI>30 at term that will be induced for obstetrical indications with a double lumen cervical ripening balloon. |
|
| BMI<30+Cervical ripening balloon | Experimental | Women with a BMI<30 at term that will be induced for obstetrical indications with a double lumen cervical ripening balloon. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dinoprostone | Drug | 10 mg of a Dinoprostone vaginal insert. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mode of delivery | Vaginal delivery in oppose to cesarean section. | Up to 5 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to delivery | Time from insertion of induction device\drug until delivery. | Up to 5 days. |
| Induction success. | Cervical dilatation and effacement after cessation of induction. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ROY LAUTERBACH, MD | Rambam Health Care Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam health care campus | Haifa | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36996264 | Derived | 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. |
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| ID | Term |
|---|---|
| D015232 | Dinoprostone |
| ID | Term |
|---|---|
| D011458 | Prostaglandins E |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
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| Double lumen cervical ripening balloon. | Device | Double lumen cervical ripening balloon. |
|
| Up to 5 days. |
| Neonatal complications and outcome. | Any neonatal complications as mentioned In the neonate's electronic file. | Up to 5 days. |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |