- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01916681
Foley OR MisO for the Management of Induction (FORMOMI)
Foley OR MisO for the Management of Induction (FOR MOMI) Trial
Study Overview
Status
Conditions
Detailed Description
Prolonged labor increases the risk of maternal and neonatal morbidity as well as increases healthcare costs. There is limited data evaluating the use of two simultaneous induction agents to decrease the time to delivery.
Maternal and neonatal morbidity with prolonged labor The adverse maternal and neonatal morbidity association with prolonged labor has been demonstrated in numerous studies. An increase in maternal risk of post partum hemorrhage and endometritis has been associated with prolonged labor. Cheng et al demonstrated that the risk of post partum hemorrhage and endometritis significantly increased with increasing length of labor. Maghoma et al evaluated the latent phase of labor and found a similar increased risk in endometritis but also noted a significant risk in maternal sepsis with a prolonged latent phase of labor.
Neonatal outcomes are similarly improved with a shorter duration of labor. In addition to the risk of chorioamnionitis and decreased 5 minute Apgar score, there is also a significantly increased risk of neonatal intensive care unit admission as well as neonatal sepsis with prolonged labor.
- Increased healthcare utilization with prolonged labor Both direct and indirect medical costs have been evaluated in the obstetrics literature. A prolonged labor has been associated with an increase in direct and indirect medical costs as well as an increase in healthcare utilization. Mackenzie et al evaluated the cost of different induction regimens and found a decreased cost for women that remained on the antenatal unit for a shorter period of time.
- Use of simultaneous induction agents Pettker et al evaluated the use of a transcervical foley with and without oxytocin and found no difference in mode of delivery or delivery within 24 hours. They found that labor was 2.5 hours shorter with the addition of oxytocin although the study was not powered to see a statistical difference. Other studies have looked at the concurrent use of prostaglandin with cervical foley. Barrilleaux et al evaluated the use of oral misoprostol with cervical foley compared to cervical foley alone and found no difference in time to delivery; however, the use of oral misprostol has well known side effects, including a high rate of tachysystole which was found in this study. Hill et al reported a decreased time to second stage and time to delivery with the use of cervical foley and oral misoprostol compared to vaginal misoprostol alone; however this was a small study that used with a higher, more favorable starting Bishop score in the combined foley+misoprostol group, biasing them away from the null. Standardized time cut offs during IOL were not used in this study. Recently, Carbone et al performed a randomized trial comparing foley bulb and misprostol to misoprostol alone and found a decreased time to delivery among those in the combined group. This study was a small trial with 60 patients in each arm and did not compare the combined agents to cervical foley alone.
- Standardization of IOL The optimal length for an IOL is not well established and data on definitions of a failed IOL and prolonged latent phase are lacking. Multiple studies have shown that within 6 hours of oxytocin administration, 60-70% of patients are in active labor. Although data suggest that the longer latent labor is allowed to proceed, the more women that will deliver vaginally, there is also evidence of an increased risk of morbidity, without a large incremental gain. Certain dosing and regimens of individual agents have been evaluated to try and decrease labor; however, studies have not evaluated the use of time cut offs during an IOL to help reduce variation in practice and standardize the IOL process.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Hospital of the University of Pennsylvania
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All women 18 years of age or greater
- singleton gestation
- vertex presentation
- 37 weeks gestational age or greater
- undergoing an IOL
- bishop score less than or equal to 6
- cervical dilation less than or equal to 2cm
Exclusion Criteria:
- All women less than 18 years of age
- Contraindication for vaginal delivery
- Prior cesarean delivery
- Multiple gestation
- Intrauterine fetal demise
- Fetal anomaly
- HIV
- Unable to consent/ non-English speaking
- Non-reassuring fetal heart rate
- Patients with hemolysis elevated liver enzymes and low platelets
- Eclampsia
- Intrauterine growth restriction (IUGR) 5th percentile with abnormal dopplers
- IUGR less than 10th percentile with reversed end diastolic flow
- Recurrent late decelerations w
- Continuous contractions more than 3 times in 10 minutes at onset of IOL (given that this is a contraindication to misoprostol use at our institution)
- Bishop score is greater than 6
- Cervical dilation greater than or equal to 2cm
- Confirmed ruptured membranes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cervical foley & Misoprostol
Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.
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A cervical foley combined with misoprostol will be used to induce the patient.
Other Names:
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Experimental: Misoprostol only
Patients randomized to this arm will receive misoprostol only to induce their labor.
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Misoprostol will be used alone to induce the patient
Other Names:
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Experimental: Cervical foley alone
Patients randomized to this arm will receive a cervical foley to induce their labor.
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A cervical foley alone will be used to induce the patient
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Experimental: Cervical foley & Pitocin
Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.
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A cervical foley combined with pitocin will be used to induce the patient
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Delivery
Time Frame: Hours between start of induction to delivery
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Amount of hours that pass between the start of the induction to delivery.
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Hours between start of induction to delivery
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Length of Stay
Time Frame: Days between admit to hospital and discharge
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Total maternal length of stay as defined as days from the day the induction began to the day of discharge
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Days between admit to hospital and discharge
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Severe RDS
Time Frame: enrollment through neonatal discharge
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enrollment through neonatal discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mode of Delivery
Time Frame: Start of induction to delivery
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Cesarean Delivery
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Start of induction to delivery
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Time to Active Labor
Time Frame: Start of induction to active labor
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Start of induction to active labor
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Regional Anesthesia
Time Frame: During delivery
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During delivery
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Chorioamnionitis
Time Frame: Enrollment through deischarge
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Enrollment through deischarge
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Maternal Morbidity
Time Frame: Enrollment through discharge
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Enrollment through discharge
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lisa D Levine, MD, University of Pennsylvania
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 817897
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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