Delivery; ProlongedFORMOMINCT01916681
Foley OR MisO for the Management of Induction
A study testing Cervical Foley & Misoprostol, Misoprostol Alone and Cervical Foley Alone in people with Delivery; Prolonged, run by University of Pennsylvania at 1 site in United States.
Trial summary
The percentage of women undergoing an induction of labor (IOL) is estimated to be 20% and continues to rise. Simultaneously, the cesarean delivery (CD) rate has continued to increase (2). Induction is a known risk factor for CD. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Delivery; Prolonged
- What is being tested?
- Cervical Foley & Misoprostol, Misoprostol Alone and Cervical Foley Alone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 491 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Jun 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- All women less than 18 years of age
- Contraindication for vaginal delivery
- Prior cesarean delivery
- Multiple gestation
- Intrauterine fetal demise
- Fetal anomaly
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Foley OR MisO for the Management of Induction (FOR MOMI) Trial
The percentage of women undergoing an induction of labor (IOL) is estimated to be 20% and continues to rise. Simultaneously, the cesarean delivery (CD) rate has continued to increase (2). Induction is a known risk factor for CD. Despite numerous studies evaluating time periods to define a failed IOL, there are no guidelines or accepted definitions of when to call an IOL failed given the incremental gain in vaginal delivery when IOL is prolonged. While decreasing the CD rate is an important primary focus in obstetrics, attention must also be paid to the overall length of labor given that prolonged labor is associated with adverse maternal and neonatal outcomes. Furthermore, a prolonged labor is associated with an increase in direct hospital costs and healthcare utilization. The use of cervical ripening agents, such as vaginal prostaglandin and mechanical dilators, has been demonstrated to reduce labor time and CD rate. In addition to specific individual agents, certain dosing and regimens for IOL and active labor have been compared to evaluate whether a particular dose or regimen can decrease the length of labor and decrease the CD rate. Most of these regimens; however, focus on individual induction agents and few have compared the efficacy of using more than one agent simultaneously. Given the associated risks of prolonged labor and limited data evaluating the use of combined cervical ripening agents, our objective is to evaluate the difference in time to delivery among women who undergo an IOL with four different methods.
Read the 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.
- Conditions
- Delivery; Prolonged
- Being tested
- Cervical Foley & Misoprostol, Misoprostol Alone, Cervical Foley Alone, Cervical Foley & Pitocin
- Keywords
- Induction, Labor, Cervical foley, Misoprostol, Pitocin, Oxytocin, Cytotec, Delivery, IOL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical Foley & MisoprostolDevice
Also called Misoprostol is also known as Cytotec
A cervical foley combined with misoprostol will be used to induce the patient.
Misoprostol AloneDrug
Also called Misoprostol is also known as Cytotec
Misoprostol will be used alone to induce the patient
Cervical Foley AloneDevice
A cervical foley alone will be used to induce the patient
Cervical Foley & PitocinDevice
Also called Pitocin is also known as Oxytocin
A cervical foley combined with pitocin will be used to induce the patient
| Study group | Role | What they receive |
|---|---|---|
| Cervical foley & Misoprostol | Experimental | Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor. Receives: Device: Cervical Foley & Misoprostol |
| Misoprostol only | Experimental | Patients randomized to this arm will receive misoprostol only to induce their labor. Receives: Drug: Misoprostol Alone |
| Cervical foley alone | Experimental | Patients randomized to this arm will receive a cervical foley to induce their labor. Receives: Device: Cervical Foley Alone |
| Cervical foley & Pitocin | Experimental | Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor. Receives: Device: Cervical Foley & Pitocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Delivery
Amount of hours that pass between the start of the induction to delivery.
Measured: Hours between start of induction to delivery
Length of Stay
Total maternal length of stay as defined as days from the day the induction began to the day of discharge
Measured: Days between admit to hospital and discharge
Severe RDS
Measured: enrollment through neonatal discharge
Secondary outcomes (5)
Mode of Delivery
Cesarean Delivery
Measured: Start of induction to delivery
Time to Active Labor
Measured: Start of induction to active labor
Regional Anesthesia
Measured: During delivery
Chorioamnionitis
Measured: Enrollment through deischarge
Maternal Morbidity
Measured: Enrollment through discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study startMay 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Delivery; ProlongedStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 491 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa D Levine, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916681
- Sponsor's protocol ID
- 817897
- Acronym
- FORMOMI
- Status last verified
- Apr 2017
- First submitted
- 30 Jul 2013
- Last updated
- 18 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
PubMed 36996264Levine 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.
PubMed 27824758
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foley OR MisO for the Management of Induction (FOR MOMI) Trial
- ClinicalTrials.gov ID
- NCT01916681
- Acronym / sponsor ID
- FORMOMI / 817897
- Conditions
- Delivery; Prolonged
- Keywords
- Induction, Labor, Cervical foley, Misoprostol, Pitocin, Oxytocin, Cytotec, Delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 491 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 6 Aug 2013 (estimated)
- Results
- Posted 21 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The percentage of women undergoing an induction of labor (IOL) is estimated to be 20% and continues to rise. Simultaneously, the cesarean delivery (CD) rate has continued to increase (2). Induction is a known risk factor for CD. Despite numerous studies evaluating time periods to define a failed IOL, there are no guidelines or accepted definitions of when to call an IOL failed given the incremental gain in vaginal delivery when IOL is prolonged. While decreasing the CD rate is an important primary focus in obstetrics, attention must also be paid to the overall length of labor given that prolonged labor is associated with adverse maternal and neonatal outcomes. Furthermore, a prolonged labor is associated with an increase in direct hospital costs and healthcare utilization. The use of cervical ripening agents, such as vaginal prostaglandin and mechanical dilators, has been demonstrated to reduce labor time and CD rate. In addition to specific individual agents, certain dosing and regimens for IOL and active labor have been compared to evaluate whether a particular dose or regimen can decrease the length of labor and decrease the CD rate. Most of these regimens; however, focus on individual induction agents and few have compared the efficacy of using more than one agent simultaneously. Given the associated risks of prolonged labor and limited data evaluating the use of combined cervical ripening agents, our objective is to evaluate the difference in time to delivery among women who undergo an IOL with four different methods.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cervical foley & Misoprostol | Experimental | Device: Cervical Foley & MisoprostolPatients randomized to this arm will receive a cervical foley and misoprostol to induce their labor. |
| Misoprostol only | Experimental | Drug: Misoprostol AlonePatients randomized to this arm will receive misoprostol only to induce their labor. |
| Cervical foley alone | Experimental | Device: Cervical Foley AlonePatients randomized to this arm will receive a cervical foley to induce their labor. |
| Cervical foley & Pitocin | Experimental | Device: Cervical Foley & PitocinPatients randomized to this arm will receive a cervical foley and pitocin to induce their labor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- All women 18 years of age or greater
- singleton gestation
- vertex presentation
- 37 weeks gestational age or greater
- undergoing an IOL
Key exclusion criteria (18 listed)
- All women less than 18 years of age
- Contraindication for vaginal delivery
- Prior cesarean delivery
- Multiple gestation
- Intrauterine fetal demise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervical Foley & MisoprostolAlso: Misoprostol is also known as CytotecA cervical foley combined with misoprostol will be used to induce the patient. | Device | Cervical foley & Misoprostol |
| Misoprostol AloneAlso: Misoprostol is also known as CytotecMisoprostol will be used alone to induce the patient | Drug | Misoprostol only |
| Cervical Foley AloneA cervical foley alone will be used to induce the patient | Device | Cervical foley alone |
| Cervical Foley & PitocinAlso: Pitocin is also known as OxytocinA cervical foley combined with pitocin will be used to induce the patient | Device | Cervical foley & Pitocin |
Primary outcome
Time to Delivery
Time frame: Hours between start of induction to delivery
Amount of hours that pass between the start of the induction to delivery.
Length of Stay
Time frame: Days between admit to hospital and discharge
Total maternal length of stay as defined as days from the day the induction began to the day of discharge
Severe RDS
Time frame: enrollment through neonatal discharge
5 secondary outcomes
Mode of Delivery
Time frame: Start of induction to delivery
Time to Active Labor
Time frame: Start of induction to active labor
Regional Anesthesia
Time frame: During delivery
Chorioamnionitis
Time frame: Enrollment through deischarge
Maternal Morbidity
Time frame: Enrollment through discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36996264de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
- Derived from this study: PubMed 27824758Levine 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa D Levine, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical Foley & Misoprostol, Misoprostol Alone and Cervical Foley Alone in people with Delivery; Prolonged, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Delivery (time frame: Hours between start of induction to delivery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01916681, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2017.