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This randomized controlled trial of consenting women undergoing induction of labor with combined combination Foley catheter and pharmacologic cervical ripening seeks to efficacy of early amniotomy.
This project will include 157 women presenting at Christiana Care Health System. Women will be included if they are at least 37 weeks gestation, have a singleton pregnancy, have intact membranes and are undergoing an induction of labor using a Foley catheter combined with either misoprostol or pitocin. Following admission, women will be randomized into either early or delayed amniotomy
Women will be randomized with equal probability to the intervention group using block randomization stratified by party.
Prior to discharge from the hospital, baseline demographic and clinical data will be obtained via chart review
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Amniotomy | Active Comparator | Women in the Early AROM group will under amniotomy one hour from Foley Catheter expulsion. Labor augmentation will continue per study protocol. Refer to Appendix A for protocol regimen. |
|
| Delayed Amniotomy | Active Comparator | Women in the Delayed AROM group will undergo amniotomy at the discretion of the obstetrician or labor provider. No specific instructions will be given. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| amniotomy | Procedure | Artificially rupturing membranes |
| |
| Measure | Description | Time Frame |
|---|---|---|
| time to delivery | time to delivery (hours) defined as time from Foley Catheter expulsion to delivery regardless of mode of delivery. | Number of hours from removal of Foley catheter to delivery of neonate; up to 72 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Cesarean delivery rate | binary; yes/no | At time of delivery |
| Time to vaginal delivery | time to delivery (hours) defined as time from Foley Catheter expulsion to delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christiana Care Health Systems | Newark | Delaware | 19713 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23926074 | Background | Wei S, Wo BL, Qi HP, Xu H, Luo ZC, Roy C, Fraser WD. Early amniotomy and early oxytocin for prevention of, or therapy for, delay in first stage spontaneous labour compared with routine care. Cochrane Database Syst Rev. 2013 Aug 7;2013(8):CD006794. doi: 10.1002/14651858.CD006794.pub4. | |
| 22959833 | Background |
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| ID | Term |
|---|---|
| D000074885 | Amniotomy |
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D007751 | Labor, Induced |
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Foley Catheter |
| Device |
Foley catheter device is commonly used for cervical ripening during labor induction. It is used independently or in combination with pharmacologic augmentation. It is inserted in the cervix and the balloon is then inflated with 60 cc of saline. |
|
| Misoprostol | Drug | Misoprostol is a medication that is commonly used for cervical ripening during labor induction. It is commonly used independently or in combination with mechanical methods, such as a foley catheter. The commonly used dose during term labor induction is 25 mcg. |
|
| At time of delivery |
| Maternal length of stay | time from admission to discharge | through study completion, an average of 4 days |
| Indication for cesarean delivery | discrete | At time of delivery |
| Chorioamnionitis | defined by the presence of maternal fever ≥100·4°f in the presence of maternal or fetal tachycardia or fundal tenderness | At time of delivery |
| 3rd/4th degree perineal laceration | binary; yes/no | at time of delivery |
| Blood transfusion | binary; yes/no | through study completion, an average of 1 year |
| Endometritis | binary; yes/no | From time of delivery to time of hospital discharge; up to 6 weeks |
| Wound separation-infection | binary, yes/no; defined by the need for additional wound closure or the need for antibiotics | through study completion, an average of 1 year |
| Neonatal death | binary, yes/no | through study completion, an average of 1 year |
| Macones GA, Cahill A, Stamilio DM, Odibo AO. The efficacy of early amniotomy in nulliparous labor induction: a randomized controlled trial. Am J Obstet Gynecol. 2012 Nov;207(5):403.e1-5. doi: 10.1016/j.ajog.2012.08.032. Epub 2012 Aug 24. |
| 11888099 | Background | Levy R, Ferber A, Ben-Arie A, Paz B, Hazan Y, Blickstein I, Hagay ZJ. A randomised comparison of early versus late amniotomy following cervical ripening with a Foley catheter. BJOG. 2002 Feb;109(2):168-72. doi: 10.1111/j.1471-0528.2002.01137.x. |
| 27824758 | Background | Levine LD, Downes KL, Elovitz MA, Parry S, Sammel MD, Srinivas SK. Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial. Obstet Gynecol. 2016 Dec;128(6):1357-1364. doi: 10.1097/AOG.0000000000001778. |
| 20502296 | Background | Delaney S, Shaffer BL, Cheng YW, Vargas J, Sparks TN, Paul K, Caughey AB. Labor induction with a Foley balloon inflated to 30 mL compared with 60 mL: a randomized controlled trial. Obstet Gynecol. 2010 Jun;115(6):1239-1245. doi: 10.1097/AOG.0b013e3181dec6d0. |
| 35135684 | Derived | Gomez Slagle HB, Fonge YN, Caplan R, Pfeuti CK, Sciscione AC, Hoffman MK. Early vs expectant artificial rupture of membranes following Foley catheter ripening: a randomized controlled trial. Am J Obstet Gynecol. 2022 May;226(5):724.e1-724.e9. doi: 10.1016/j.ajog.2021.11.1368. Epub 2022 Feb 6. |
| 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 |