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The purpose of this study is to investigate whether mechanical cervical ripening (using the Cook double balloon catheter) is superior or inferior to pharmacological agents (PGE1) in overweight and obese women undergoing labor induction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cook double balloon catheter | Experimental | Insertion of the Cook double balloon catheter to the cervix until both balloons are properly located in the cervical canal. After properly located it is inflated with 20 ml of saline. Then both balloons are additionally inflated to a total of 80 ml each balloon. Twelve hours later the balloons are deflated and the device is removed. |
|
| PGE1 tablet insertion | Active Comparator | Insertion of 25 mg PGE1 (Prostaglandin E1) tablet is inserted in the posterior fornix. The patient woll the be instructed to stay in bed for the next 60 minutes. After six hours a repeated dose will be administered. Total of 4 PGE1 doses within 24 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cook double balloon catheter | Device |
| ||
| PGE1 tablet |
| Measure | Description | Time Frame |
|---|---|---|
| Cesarian section rate | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of excessive uterine activity Incidence of excessive uterine activity | At least 6 uterine contractions per 10- minutes period, or hyperstimulation, if combined with fetal heart rate abnormalities, or hypertonus defined as single contraction of 2-minute duration. | 24 hours |
| Active labor onset |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Saja Murra Anabosy, MD | Contact | +972 50 9260067 | saja83@gmail.com | |
| Asnat Walfisch, MD | Contact | +972 50 4492200 | asnatwalfisch@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Saja Murra Anabosy, MD | Hillel Yaffe Medical Center | Principal Investigator |
| Asnat Walfisch, MD | Hillel Yaffe Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hillel Yaffe Medical Center | Hadera | 169 | 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 |
|---|---|
| D009765 | Obesity |
| D007744 | Obstetric Labor Complications |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000527 | Alprostadil |
| ID | Term |
|---|---|
| D011458 | Prostaglandins E |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
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| Drug |
|
|
| 24 hours |
| Proportion of vaginal delivery | 24 hours |
| Treatment failure | Proportion of subjects with unfavorable/unchanged Bishop score 12-24 hours after ripening | 12-24 hours |
| The ripening-to-delivery time interval | 24 hours |
| Need for oxytocin induction and/or augmentation of labor | 24 hours |
| Mode of delivery | NVD vs. instrumental | 24 hours |
| Intra-partum or postpartum fever | 48 hours |
| Incidence of meconium staining | 24 hours |
| The proportion of neonates with 5-minute Apgar scores of less than 7 | 48 hours |
| The number of neonates who were admitted to the neonatal intensive care unit | 48 hours |
| morbidity and mortality | Number of cases of serious maternal and/or neonatal morbidity or death (including uterine rupture, maternal admission to the intensive care unit, maternal septicemia, placental abruption, hemorrhage at required blood transfusion, hysterectomy, neonatal seizures, birth asphyxia, meconium aspiration syndrome, or neonatal sepsis). | 48 hours |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D005229 | Fatty Acids, Monounsaturated |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |