Not provided
Not provided
Not provided
Not provided
Not provided
Insufficient research staff to recruit and complete study
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to study if misoprostol administered orally is at least as effective as misoprostol administered vaginally for cervical ripening and the induction of labor. The main purpose is to show that oral misoprostol administration is non-inferior to vaginal misoprostol administration with respect to the time interval from misoprostol administration to onset of active phase of labor. The study is a non-inferiority, prospective randomized controlled trial comparing oral misoprostol given as 25 mcg every 2 hours versus vaginal misoprostol given as 25 mcg every 4 hours.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral misoprostol | Experimental | oral misoprostol given 25 mcg every 2 hours |
|
| Vaginal misoprostol | Active Comparator | vaginal misoprostol given 25 mcg every 4 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug | Comparing dosing of misoprostol 25 mcg orally every 2 hours versus 25 mcg vaginally every 4 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Active Labor | Active phase of labor defined as greater than or equal to 6 cm cervical dilation | from start of induction of labor (first misoprostol administration) to active phase of labor, up to 3 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Initiation of Oxytocin for Labor Augmentation | The length of time (in hours) between the administration of misoprostol (first dose) and the first administration of oxytocin for labor augmentation. | From start of induction of labor (first misoprostol administration) to initiation of oxytocin for labor augmentation, up to 36 hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jaimey Pauli, MD | Milton S. Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34155622 | Derived | Kerr RS, Kumar N, Williams MJ, Cuthbert A, Aflaifel N, Haas DM, Weeks AD. Low-dose oral misoprostol for induction of labour. Cochrane Database Syst Rev. 2021 Jun 22;6(6):CD014484. doi: 10.1002/14651858.CD014484. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Oral Misoprostol | oral misoprostol given 25 mcg every 2 hours |
| FG001 | Vaginal Misoprostol | vaginal misoprostol given 25 mcg every 4 hours |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Oral Misoprostol | oral misoprostol given 25 mcg every 2 hours |
| BG001 | Vaginal Misoprostol | vaginal misoprostol given 25 mcg every 4 hours |
| 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 to Active Labor | Active phase of labor defined as greater than or equal to 6 cm cervical dilation | Subjects who reached active phase of labor. | Posted | Mean | Standard Deviation | hours | from start of induction of labor (first misoprostol administration) to active phase of labor, up to 3 days. |
|
During hospital stay-admission for induction until discharge after delivery, up to 7 days.
Charts were reviewed for the specific events of postpartum hemorrhage requiring blood transfusion, maternal surgical ICU admission and neonatal NICU admission during the maternal hospital stay (admission for induction until discharge after delivery, up to 7 days).
Not provided
| 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 | oral misoprostol given 25 mcg every 2 hours | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neonatal NICU admission | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
Limitations include that during the COVID-19 pandemic, all in person research was suspended. Research time was reallocated to clinical time for providers. Recruitment was difficult. We had multiple changes in the research team requiring retraining. Ultimately, we were not able to recruit the numbers needed so the trial was terminated with inadequate numbers of subjects analyzed. Multiple turnovers led to a delay in completing our close out.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jaimey Pauli | Penn State Milton S. Hershey Medical Center | 717-531-8142 | 5 | jpauli@pennstatehealth.psu.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 15, 2021 | Aug 15, 2022 | Prot_SAP_ICF_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Time to Vaginal Delivery |
includes vaginal deliveries only; cesarean section deliveries are excluded |
| from start of induction of labor (first misoprostol administration) to vaginal delivery, up to 3 days |
| Cesarean Section Rate | Number of cesarean sections/total deliveries (%) | From enrollment until delivery, up to 3 days |
| Rate of Tachysystole | Tachysystole is defined as 4 or more contractions in a 10 minute period. | from enrollment until delivery, up to 3 days |
| Rate of Tachysystole Causing Non-reassuring Fetal Heart Tones | Previously defined as "hyperstimulation", this outcome measure is defined as 4 or more contractions in a 10 minute period (tachysystole) thought to be causing recurrent variable or late decelerations, bradycardia, or minimal variability in the fetal heart rate tracing (non-reassuring fetal heart tones,which would require intervention to resolve or delivery of the infant). | From enrollment until delivery, up to 3 days |
| Rate of Need for Tocolysis | Tocolysis is the administration of medication to decrease or stop contractions. | from enrollment until delivery, up to 3 days |
| Rate of Chorioamnionitis | Chorioamnionitis is defined as an intraamniotic infection. | from enrollment until delivery, up to 3 days |
| Rate of Meconium Stained Fluid | Amniotic fluid with visible meconium (from fetal defecation) within it. | from enrollment until delivery, up to 3 days |
| Neonatal Morbidity | binary composite outcome defined as Apgar score < 7, or cord blood gas pH of less than 7 or base deficit great than 12, or neonatal intensive care unit admission within 4 hours of delivery. | 4 hours from delivery |
| Rate of Anti-emetic Use | Use of medication to treat nausea. | from enrollment until delivery, up to 3 days |
| Rate of Vaginal Delivery Within 24 Hours | Vaginal delivery within from start of induction with misoprostol. | 24 hours from start of induction of labor (first misoprostol administration) |
| Rate of Abandoning Misoprostol for Cervical Ripening and Switching to Mechanical Dilation for Cervical Ripening | Based on clinician's judgment on the progress of the induction, the rate that misoprostol administration was stopped and a cervical ripening balloon was used instead | from enrollment until delivery, up to 3 days |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Secondary | Time to Initiation of Oxytocin for Labor Augmentation | The length of time (in hours) between the administration of misoprostol (first dose) and the first administration of oxytocin for labor augmentation. | Subjects who initiated oxytocin | Posted | Mean | Standard Deviation | hours | From start of induction of labor (first misoprostol administration) to initiation of oxytocin for labor augmentation, up to 36 hours |
|
|
|
|
| Secondary | Time to Vaginal Delivery | includes vaginal deliveries only; cesarean section deliveries are excluded | vaginal deliveries | Posted | Mean | Standard Deviation | hours | from start of induction of labor (first misoprostol administration) to vaginal delivery, up to 3 days |
|
|
|
|
| Secondary | Cesarean Section Rate | Number of cesarean sections/total deliveries (%) | Posted | Count of Participants | Participants | From enrollment until delivery, up to 3 days |
|
|
|
|
| Secondary | Rate of Tachysystole | Tachysystole is defined as 4 or more contractions in a 10 minute period. | Posted | Count of Participants | Participants | from enrollment until delivery, up to 3 days |
|
|
|
|
| Secondary | Rate of Tachysystole Causing Non-reassuring Fetal Heart Tones | Previously defined as "hyperstimulation", this outcome measure is defined as 4 or more contractions in a 10 minute period (tachysystole) thought to be causing recurrent variable or late decelerations, bradycardia, or minimal variability in the fetal heart rate tracing (non-reassuring fetal heart tones,which would require intervention to resolve or delivery of the infant). | Posted | Count of Participants | Participants | From enrollment until delivery, up to 3 days |
|
|
|
|
| Secondary | Rate of Need for Tocolysis | Tocolysis is the administration of medication to decrease or stop contractions. | Posted | Count of Participants | Participants | from enrollment until delivery, up to 3 days |
|
|
|
|
| Secondary | Rate of Chorioamnionitis | Chorioamnionitis is defined as an intraamniotic infection. | Posted | Count of Participants | Participants | from enrollment until delivery, up to 3 days |
|
|
|
| Secondary | Rate of Meconium Stained Fluid | Amniotic fluid with visible meconium (from fetal defecation) within it. | Posted | Count of Participants | Participants | from enrollment until delivery, up to 3 days |
|
|
|
|
| Secondary | Neonatal Morbidity | binary composite outcome defined as Apgar score < 7, or cord blood gas pH of less than 7 or base deficit great than 12, or neonatal intensive care unit admission within 4 hours of delivery. | Excludes neonates with APGAR score>7 not admitted to NICU but were missing cord blood gas results | Posted | Count of Participants | Participants | 4 hours from delivery |
|
|
|
|
| Secondary | Rate of Anti-emetic Use | Use of medication to treat nausea. | Posted | Count of Participants | Participants | from enrollment until delivery, up to 3 days |
|
|
|
|
| Secondary | Rate of Vaginal Delivery Within 24 Hours | Vaginal delivery within from start of induction with misoprostol. | vaginal deliveries only | Posted | Count of Participants | Participants | 24 hours from start of induction of labor (first misoprostol administration) |
|
|
|
|
| Secondary | Rate of Abandoning Misoprostol for Cervical Ripening and Switching to Mechanical Dilation for Cervical Ripening | Based on clinician's judgment on the progress of the induction, the rate that misoprostol administration was stopped and a cervical ripening balloon was used instead | Posted | Count of Participants | Participants | from enrollment until delivery, up to 3 days |
|
|
|
|
| 17 |
| 0 |
| 17 |
| 1 |
| 17 |
| EG001 | Vaginal Misoprostol | vaginal misoprostol given 25 mcg every 4 hours | 0 | 17 | 0 | 17 | 1 | 17 |
Not provided
Not provided
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |