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Premature rupture of membranes (PROM) is a common occurrence of pregnancies at term. A delay from PROM to labor is associated with an increased risk of intrauterine infection and associated maternal and fetal morbidity; therefore, induction of labor (IOL) is recommended. The ideal agent for IOL is not known, particularly among specific subpopulations. The primary aim of this study is to determine if oxytocin (Pitocin) or oral misoprostol results in a shorter interval to delivery after the start of induction among nulliparous women with unfavorable cervical exams with term PROM.
Premature rupture of membranes (PROM) occurs in approximately 8% of pregnancies at term.1 Although onset of spontaneous labor is often prompt after membrane rupture, a delay from PROM to labor is associated with an increased risk of intrauterine infection and its associated maternal and fetal complications. For this reason, the American College of Obstetricians and Gynecologists (ACOG) endorses induction of labor for PROM "if spontaneous labor does not occur near the time of presentation."
The optimal method for PROM induction is less clear. Prior literature has examined the use of Pitocin (Oxytocin), vaginal and oral misoprostol, and dinoprost with mixed results. The TermPROM study found an increased risk of chorioamnionitis and Neonatal Intensive Care Unit (NICU) admission among women treated with vaginal misoprostol for induction.
The postulated link between vaginal misoprostol and chorioamnionitis is the need for vaginal examination for placement of the misoprostol; more vaginal examinations could potentially increase the risk for infection. Utilizing oral misoprostol would eliminate the need for a vaginal exam for administration, thereby potentially mitigating this risk of infection. Currently, vaginal and oral misoprostol as well as oxytocin are used routinely in clinical care based on provider discretion.
Among 7 randomized controlled trials examining the use of oral misoprostol as compared to oxytocin, two found oral misoprostol to result in faster induction to delivery, two found oxytocin to result in faster deliveries, and the remaining three found no difference between the two.3-9 These studies are limited by small sample size, inadequate reporting of patient demographics, varied misoprostol and oxytocin protocols, and inconsistent primary outcomes. Therefore, the utility of oral misoprostol in this population has not been established. Furthermore, its efficacy in specific patient populations is unreported in the literature.
The primary aim of this study is to determine if oxytocin or oral misoprostol results in a shorter interval to delivery after the start of induction among nulliparous women with unfavorable cervical exams with PROM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Misoprostol | Active Comparator |
| |
| Oxytocin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug | Oral misoprostol 50 mcg every 4 hours for up to 6 doses or until cervical ripening is no longer indicated |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time From Induction of Labor (IOL) to Delivery | Time (hours) from start of IOL (As defined by receipt of first medication for induction of labor) to delivery of infant. | Time (hours) from start of IOL (As defined by receipt of first medication for induction of labor) to delivery of infant. |
| Measure | Description | Time Frame |
|---|---|---|
| Infection | Suspected intraamniotic infection | Enrollment to Delivery |
| Time From Premature Rupture of Membranes (PROM) to Delivery | Time (hours) from PROM (as reported by patient) to delivery of infant |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29266075 | Background | Committee on Practice Bulletins-Obstetrics. ACOG Practice Bulletin No. 188: Prelabor Rupture of Membranes. Obstet Gynecol. 2018 Jan;131(1):e1-e14. doi: 10.1097/AOG.0000000000002455. | |
| 8598837 | Background | Hannah ME, Ohlsson A, Farine D, Hewson SA, Hodnett ED, Myhr TL, Wang EE, Weston JA, Willan AR. Induction of labor compared with expectant management for prelabor rupture of the membranes at term. TERMPROM Study Group. N Engl J Med. 1996 Apr 18;334(16):1005-10. doi: 10.1056/NEJM199604183341601. |
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Began: August 2019 End: May 2023 (Last participant follow-up completed 1/8/2023. Additional subjects were screened/approached for participation through 5/2023.) Location: Labor and Delivery
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Misoprostol | Misoprostol: Oral misoprostol 50 mcg every 4 hours for up to 6 doses or until cervical ripening is no longer indicated |
| FG001 | Oxytocin | Oxytocin: IV Oxytocin 2 milliunits (mU)/min, increased by 2mU/min q15 minutes per hospital protocol. Max 40 mU/min |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oral Misoprostol | Misoprostol: Oral misoprostol 50 mcg every 4 hours for up to 6 doses or until cervical ripening is no longer indicated |
| BG001 | Oxytocin | Oxytocin: IV Oxytocin 2 milliunits (mU)/min, increased by 2mU/min q15 minutes per hospital protocol. Max 40 mU/min |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time From Induction of Labor (IOL) to Delivery | Time (hours) from start of IOL (As defined by receipt of first medication for induction of labor) to delivery of infant. | Posted | Median | Inter-Quartile Range | Hours | Time (hours) from start of IOL (As defined by receipt of first medication for induction of labor) to delivery of infant. |
|
From trial enrollment to one month post-delivery (Maternal) or hospital discharge (Neonatal)
Adverse events as described per maternal and neonatal subject. Described adverse event numbers are per event (ie. subject may have experienced more than one event).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oral Misoprostol-Mothers | Misoprostol: Oral misoprostol 50 mcg every 4 hours for up to 6 doses or until cervical ripening is no longer indicated Adverse Maternal Events Only |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neonatal Hypoxic Ischemic Encephalopathy | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NICU Admission > 48 hours | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Whitney Bender | Thomas Jefferson University Health System | 4342948416 | whitney.bender@jefferson.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 27, 2020 | Mar 5, 2024 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 22, 2023 | Mar 5, 2024 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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| Oxytocin | Drug | IV Oxytocin 2 milliunits (mU)/min, increased by 2mU/min q15 minutes per hospital protocol |
|
| Time From IOL to Vaginal Delivery | Time from IOL (as defined by receipt of first medication for induction) to vaginal delivery |
| Time From PROM to Vaginal Delivery | Time (hours) from PROM (as reported by patient) to vaginal delivery |
| Cesarean Delivery | Cesarean section rate | Enrollment to Delivery |
| Maternal Morbidity | Composite maternal morbidity: postpartum hemorrhage, blood transfusion, endometritis, wound infection, venous thromboembolism (VTE), hysterectomy, Intensive care unit (ICU) admission, readmission within 4 weeks, death | Enrollment to 4 weeks postpartum |
| Neonatal Morbidity | Composite neonatal morbidity: NICU admission > 48 hours, neonatal blood transfusion, hypoxic ischemic encephalopathy, intraventricular hemorrhage grade III or IV, headcooling, severe respiratory distress syndrome, necrotizing enterocolitis, sepsis, death | Enrollment to hospital discharge (On average 2-4 days) |
| 12834947 | Background | Al-Hussaini TK, Abdel-Aal SA, Youssef MA. Oral misoprostol vs. intravenous oxytocin for labor induction in women with prelabor rupture of membranes at term. Int J Gynaecol Obstet. 2003 Jul;82(1):73-5. doi: 10.1016/s0020-7292(03)00136-x. No abstract available. |
| 14526301 | Background | Crane JM, Delaney T, Hutchens D. Oral misoprostol for premature rupture of membranes at term. Am J Obstet Gynecol. 2003 Sep;189(3):720-4. doi: 10.1067/s0002-9378(03)00768-3. |
| 10576189 | Background | Butt KD, Bennett KA, Crane JM, Hutchens D, Young DC. Randomized comparison of oral misoprostol and oxytocin for labor induction in term prelabor membrane rupture. Obstet Gynecol. 1999 Dec;94(6):994-9. doi: 10.1016/s0029-7844(99)00423-8. |
| 10688506 | Background | Ngai SW, Chan YM, Lam SW, Lao TT. Labour characteristics and uterine activity: misoprostol compared with oxytocin in women at term with prelabour rupture of the membranes. BJOG. 2000 Feb;107(2):222-7. doi: 10.1111/j.1471-0528.2000.tb11693.x. |
| 14586349 | Background | Mozurkewich E, Horrocks J, Daley S, Von Oeyen P, Halvorson M, Johnson M, Zaretsky M, Tehranifar M, Bayer-Zwirello L, Robichaux A 3rd, Droste S, Turner G; MisoPROM study. The MisoPROM study: a multicenter randomized comparison of oral misoprostol and oxytocin for premature rupture of membranes at term. Am J Obstet Gynecol. 2003 Oct;189(4):1026-30. doi: 10.1067/s0002-9378(03)00845-7. |
| 26866082 | Background | Mbaluka CM, Kamau K, Karanja JG, Mugo N. EFFECTIVENESS AND SAFETY OF 2-HOURLY 20 MCG ORAL MISOPROSTOL SOLUTION COMPARED TO STANDARD INTRAVENOUS OXYTOCIN IN LABOUR INDUCTION DUE TO PRE-LABOUR RUPTURE OF MEMBRANES AT TERM: A RANDOMISED CLINICAL TRIAL AT KENYATTA NATIONAL HOSPITAL. East Afr Med J. 2014 Sep;91(9):303-10. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Public Insurance | Count of Participants | Participants |
|
| BMI | Median | Inter-Quartile Range | kg/m^2 |
|
| Prenatal Visit Number | Median | Inter-Quartile Range | Visits |
|
| Gestational age at Rupture of Membranes | Median | Inter-Quartile Range | Weeks |
|
| Starting Cervical Dilation | Mean | Standard Deviation | Centimeters |
|
| Starting Bishop Score | The Bishop score is a commonly used method to rate cervical ripeness for induction of labor. The score ranges from 0-12 with points awarded for cervical dilation, cervical effacement, fetal station, cervical consistency, and cervical position. Scores for each of those 5 categories are added to generate a total score. Higher scores indicate more favorable (or ripe) cervical examinations | Mean | Standard Deviation | Units on a scale. |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Infection | Suspected intraamniotic infection | Posted | Count of Participants | Participants | Enrollment to Delivery |
|
|
|
| Secondary | Time From Premature Rupture of Membranes (PROM) to Delivery | Posted | Median | Inter-Quartile Range | Hours | Time (hours) from PROM (as reported by patient) to delivery of infant |
|
|
|
| Secondary | Time From IOL to Vaginal Delivery | Posted | Median | Inter-Quartile Range | Hours | Time from IOL (as defined by receipt of first medication for induction) to vaginal delivery |
|
|
|
| Secondary | Time From PROM to Vaginal Delivery | Posted | Median | Inter-Quartile Range | Hours | Time (hours) from PROM (as reported by patient) to vaginal delivery |
|
|
|
| Secondary | Cesarean Delivery | Cesarean section rate | Posted | Count of Participants | Participants | Enrollment to Delivery |
|
|
|
| Secondary | Maternal Morbidity | Composite maternal morbidity: postpartum hemorrhage, blood transfusion, endometritis, wound infection, venous thromboembolism (VTE), hysterectomy, Intensive care unit (ICU) admission, readmission within 4 weeks, death | Posted | Count of Participants | Participants | Enrollment to 4 weeks postpartum |
|
|
|
| Secondary | Neonatal Morbidity | Composite neonatal morbidity: NICU admission > 48 hours, neonatal blood transfusion, hypoxic ischemic encephalopathy, intraventricular hemorrhage grade III or IV, headcooling, severe respiratory distress syndrome, necrotizing enterocolitis, sepsis, death | Posted | Count of Participants | Participants | Enrollment to hospital discharge (On average 2-4 days) |
|
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| 3 |
| 52 |
| EG001 | Oxytocin-Mothers | Oxytocin: IV Oxytocin 2 milliunits (mU)/min, increased by 2mU/min q15 minutes per hospital protocol. Max 40 mU/min Adverse Maternal Events only | 0 | 56 | 0 | 56 | 3 | 56 |
| EG002 | Oral Misoprostol-Fetus/Neonate | Misoprostol: Oral misoprostol 50 mcg every 4 hours for up to 6 doses or until cervical ripening is no longer indicated Adverse Neonatal Events Only | 0 | 52 | 1 | 52 | 1 | 52 |
| EG003 | Oxytocin-Fetus/Neonate | Oxytocin: IV Oxytocin 2 milliunits (mU)/min, increased by 2mU/min q15 minutes per hospital protocol. Max 40 mU/min Adverse Neonatal Events only | 0 | 56 | 0 | 56 | 2 | 56 |
| Postpartum Readmission | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Blood transfusion | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
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| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |