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| ID | Type | Description | Link |
|---|---|---|---|
| A532860 | Other Identifier | UW Madison | |
| SMPH/OBSTET & GYNECOL | Other Identifier | UW Madison | |
| Protocol Version 9/20/2023 | Other Identifier | UW Madison | |
| 2020-0240 | Other Identifier | UW-Madison IRB |
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This is a prospective, randomized trial looking at the ideal method of labor induction for women with prelabor rupture of membranes and an unfavorable cervical Bishop score. The study will compare oral misoprostol and intravenous oxytocin.
The purpose of this study is to look at optimal induction management of prelabor rupture of membranes (PROM) at or beyond 34 weeks gestational age.
Objective 1: To determine if there is a decrease in time from initiation of induction of labor to vaginal delivery in women with an unfavorable cervix with the use of oral misoprostol versus intravenous oxytocin.
Hypothesis: Cervical ripening with misoprostol will be beneficial in women with an unfavorable cervix.
Sub objective 1: To determine if the use of oral misoprostol for cervical ripening decreases the rate of postpartum hemorrhage in women with PROM.
Hypothesis: Misoprostol use will result in significantly lower rate of postpartum hemorrhage.
Sub objective 2: To evaluate the rates of infectious morbidity in peripartum women and neonates exposed to misoprostol versus oxytocin in PROM.
Hypothesis: The use of oral misoprostol will result in lower rates of infectious morbidity in mother and neonate.
Sub objective 3: To analyze patient satisfaction surveys. Hypothesis: Patients in the oral misoprostol group will be more satisfied with their labor experience.
Exploratory Outcome To determine if there is a difference in cost between induction of labor in women with an unfavorable cervix with the use of oral misoprostol versus intravenous oxytocin.
Hypothesis: The use of oral misoprostol will be cost effective in women presenting with PROM and an unfavorable cervix.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oral misoprostol | Active Comparator | At time of delivery, participants randomly assigned to either oral misoprostol will receive 50 mcg of Misoprostol every 4 hours up to 6 doses, OR until simplified Bishop score >6 (whichever is achieved first). |
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| intravenous oxytocin | Active Comparator | At time of delivery, participants randomly assigned to intravenous oxytocin, will be administered the drug per standard of labor and delivery titrations. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol Oral Product | Drug | Misoprostol will be dosed using the preexisting UnityPoint Health-Meriter Protocol for oral misoprostol administration. |
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| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoint: Time from initial medication administration to vaginal delivery | time from initiation of induction of labor to vaginal delivery in women with an unfavorable cervix with the use of oral misoprostol versus intravenous oxytocin | Up to 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary endpoint 1: Rate of Postpartum Hemorrhage | the rate of postpartum hemorrhage in women with prelabor rupture of membranes with use of oral misoprostol for cervical ripening | up to 24 hours for immediate postpartum hemorrhage |
| Secondary endpoint 2: Rate of Suspected or Confirmed Intrapartum Intramniotic Infection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacquelyn Adams, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UnityPoint Health- Meriter Hospital | Madison | Wisconsin | 53705-2216 | United States |
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| ID | Term |
|---|---|
| D005322 | Fetal Membranes, Premature Rupture |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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| Intravenous Oxytocin | Drug | Intravenous oxytocin administration will also follow standard, UnityPoint Health-Meriter Protocol. |
|
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Rates of infectious morbidity in peripartum women and neonates exposed to misoprostol versus oxytocin in prelabor rupture of membranes. |
| Prior to delivery |
| Secondary endpoint 3: Rate of Suspected Endometritis | patient satisfaction surveys | From delivery to 6 weeks postpartum |
| Secondary endpoint 4: Rate of Infectious Morbidity for Neonates | Neonatal infection that is diagnosed within the first 6 weeks of life related to maternal infection diagnosed by positive blood cultures or fever. | up to 6 weeks of life |
| Secondary endpoint 5: Participant Satisfaction as Measured by modified Labour Agentry Scale | The modified labour agentry scale has scores that indicate satisfaction with the patient's experience in labor | Postpartum day one with repeat instrument at 6 weeks postpartum |