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The purpose of this study is to specifically investigate whether oxytocin and mechanical dilation decreases the rate of cesarean section compared to misoprostol and mechanical dilation for pregnancies at risk of fetal compromise
This is a single center randomized control trial of two arms. Singleton, cephalic, high risk pregnancies will be randomized to either oxytocin with mechanical dilation versus misoprostol with mechanical dilation.
In group A, receiving misoprostol with mechanical dilation, will serve as the control group. Group B, oxytocin with mechanical dilation, will serve as the experimental group. The expected duration of participation begins at induction of labor and concludes at time of delivery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxytocin with Mechanical Dilation | Experimental | If the patient is randomized to Cook Balloon and Oxytocin - The balloon inflated to 60cc will be placed and oxytocin 2 mu/min will be initiated, and increased incrementally by 2mu/min every 30 minutes. If the cook cannot be placed initially, it will be reattempted and placed within 6 hours of oxytocin starting. The Cook catheter will remain in place until spontaneously expelled, or if not, after 12 hours of placement. If a Cook Balloon is not available, a Foley catheter can be used in its place as alternate and equivalent form of mechanical dilation. |
|
| Misoprostol with Mechanical Dilation | Active Comparator | If the patient is randomized to Misoprostol and Cook balloon - she will be given 25mcg of misoprostol orally or buccal and a Cook Balloon inflated to 60cc will be placed. She will subsequently receive 50mcg oral or buccal misoprostol every 4 hours up to 4 doses. If regular contractions occur (three or more contractions in a 10-minute period), the patient will be switched to Oxytocin 2 mu/min, and increased incrementally by 2mu/min every 30 minutes. If the cook balloon cannot be placed initially, it will be reattempted and placed within 6 hours of induction start. The Cook catheter will remain in place until spontaneously expelled, or at the fourth misoprostol administration. At this point, oxytocin will be started if not already initiated and artificial rupture of membranes will occur |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug | Intervention |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Cesarean Delivery | Total rate of cesarean delivery | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| The time interval from induction-to-delivey for vaginal deliveries | Maternal outcome | 48 hours |
| The number of vaginal births within 24 hours | Maternal outcome |
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Inclusion Criteria:
• Age > 18 years old
Exclusion Criteria:
• Prior cesarean delivery
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37806650 | Derived | Al-Hafez L, Khanuja K, Mendez-Figueroa H, Al-Kouatly HB, Mascio DD, Chauhan SP, Berghella V. Misoprostol with balloon vs oxytocin with balloon in high-risk pregnancy induction: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 Dec;5(12):101175. doi: 10.1016/j.ajogmf.2023.101175. Epub 2023 Oct 6. |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Misoprostol | Drug | Control |
|
|
| 24 hours |
| The number of misoprostol doses received by each participant | Maternal outcome | 24 hours |
| The incidence of uterine tachysystole | Defined as greater than 5 contractions in a ten minute window, averaged over 30 minutes | 24 hours |
| The rate of each indication for the cesarean delivery | Indications include non-reassuring fetal hear tones, arrest of dilation, arrest in the 2nd stage of labor etc. | 48 hours |
| The rate of operative vaginal delivery | Maternal outcome - includes forceps or vacuum assisted deliveries | 48 hours |
| The rate of intra-amniotic infection | Maternal outcome | 48 hours |
| The rate of postpartum hemorrhage | Maternal outcome | 24 hours |
| The rate of Fetal heart rate abnormaliies | recurrent late decelerations, bradycardia, or prolonged deceleration | 48 hours |
| The number of patients that received betamethasone for fetal lung maturity and/or magnesium sulfate for fetal neuroprotection | Maternal outcome | 24 hours |
| The rate of stillbirth | Fetal/Neonatal outcome | 48 hours |
| The total rate of Neonatal Apgar scores less than 7 at 5 minutes | Neonatal outcome | 5 minutes |
| The total rate of Neonatal RDS | Neonatal outcome | 96 hours |
| The total rate of Neonatal admission to the NICU | Neonatal outcome | 96 hours |
| The total rate of neonatal arterial umbilical blood pH < 7.1 | Neonatal outcome | 96 hours |
| The rate of neonatal Sepsis | Neonatal outcome | 96 hours |
| The rate of Neonatal Death | Neonatal outcome | 96 hours |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |