Skip to content

Foley OR MisO for the Management of Induction

Foley OR MisO for the Management of Induction (FOR MOMI) Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01916681
Acronym
FORMOMI
Enrollment
491
Registered
2013-08-06
Start date
2013-05-31
Completion date
2015-06-30
Last updated
2017-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delivery; Prolonged

Keywords

Induction, Labor, Cervical foley, Misoprostol, Pitocin, Oxytocin, Cytotec, Delivery, IOL

Brief 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. 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. 1. 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. 2. 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. 3. 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. 4. 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.

Interventions

DEVICECervical Foley & Misoprostol

A cervical foley combined with misoprostol will be used to induce the patient.

Misoprostol will be used alone to induce the patient

DEVICECervical Foley Alone

A cervical foley alone will be used to induce the patient

DEVICECervical Foley & Pitocin

A cervical foley combined with pitocin will be used to induce the patient

Sponsors

University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time to DeliveryHours between start of induction to deliveryAmount of hours that pass between the start of the induction to delivery.
Length of StayDays between admit to hospital and dischargeTotal maternal length of stay as defined as days from the day the induction began to the day of discharge
Severe RDSenrollment through neonatal discharge

Secondary

MeasureTime frameDescription
ChorioamnionitisEnrollment through deischarge
Mode of DeliveryStart of induction to deliveryCesarean Delivery
Maternal MorbidityEnrollment through discharge
Time to Active LaborStart of induction to active labor
Regional AnesthesiaDuring delivery

Countries

United States

Participant flow

Participants by arm

ArmCount
Cervical Foley & Misoprostol
Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor. Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient.
123
Misoprostol Only
Patients randomized to this arm will receive misoprostol to induce their labor. Misoprostol Alone: Misoprostol will be used alone to induce the patient
120
Cervical Foley Alone
Patients randomized to this arm will receive a cervical foley to induce their labor. Cervical Foley Alone: A cervical foley alone will be used to induce the patient
123
Cervical Foley & Pitocin
Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor. Cervical Foley & Pitocin: A cervical foley combined with pitocin will be used to induce the patient
125
Total491

Baseline characteristics

CharacteristicMisoprostol OnlyCervical Foley AloneCervical Foley & MisoprostolCervical Foley & PitocinTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
120 Participants123 Participants123 Participants125 Participants491 Participants
Age, Continuous26.7 Years27.3 Years28 Years26.5 Years27 Years
Region of Enrollment
United States
120 participants123 participants123 participants125 participants491 participants
Sex: Female, Male
Female
120 Participants123 Participants123 Participants125 Participants491 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
30 / 12333 / 12046 / 12346 / 125
serious
Total, serious adverse events
0 / 1230 / 1200 / 1230 / 125

Outcome results

Primary

Length of Stay

Total maternal length of stay as defined as days from the day the induction began to the day of discharge

Time frame: Days between admit to hospital and discharge

ArmMeasureValue (MEDIAN)
Cervical Foley & MisoprostolLength of Stay3 Days
Misoprostol OnlyLength of Stay3 Days
Cervical Foley AloneLength of Stay3 Days
Cervical Foley & PitocinLength of Stay3 Days
Primary

Severe RDS

Time frame: enrollment through neonatal discharge

ArmMeasureValue (NUMBER)
Cervical Foley & MisoprostolSevere RDS0 participants
Misoprostol OnlySevere RDS1 participants
Cervical Foley AloneSevere RDS2 participants
Cervical Foley & PitocinSevere RDS0 participants
Primary

Time to Delivery

Amount of hours that pass between the start of the induction to delivery.

Time frame: Hours between start of induction to delivery

ArmMeasureValue (MEDIAN)
Cervical Foley & MisoprostolTime to Delivery13.1 Hours
Misoprostol OnlyTime to Delivery17.6 Hours
Cervical Foley AloneTime to Delivery17.7 Hours
Cervical Foley & PitocinTime to Delivery14.5 Hours
Secondary

Chorioamnionitis

Time frame: Enrollment through deischarge

ArmMeasureValue (NUMBER)
Cervical Foley & MisoprostolChorioamnionitis15 participants
Misoprostol OnlyChorioamnionitis9 participants
Cervical Foley AloneChorioamnionitis17 participants
Cervical Foley & PitocinChorioamnionitis20 participants
Secondary

Maternal Morbidity

Time frame: Enrollment through discharge

ArmMeasureValue (NUMBER)
Cervical Foley & MisoprostolMaternal Morbidity5 participants
Misoprostol OnlyMaternal Morbidity8 participants
Cervical Foley AloneMaternal Morbidity13 participants
Cervical Foley & PitocinMaternal Morbidity10 participants
Secondary

Mode of Delivery

Cesarean Delivery

Time frame: Start of induction to delivery

ArmMeasureValue (NUMBER)
Cervical Foley & MisoprostolMode of Delivery34 participants
Misoprostol OnlyMode of Delivery29 participants
Cervical Foley AloneMode of Delivery35 participants
Cervical Foley & PitocinMode of Delivery38 participants
Secondary

Regional Anesthesia

Time frame: During delivery

ArmMeasureValue (NUMBER)
Cervical Foley & MisoprostolRegional Anesthesia114 participants
Misoprostol OnlyRegional Anesthesia111 participants
Cervical Foley AloneRegional Anesthesia114 participants
Cervical Foley & PitocinRegional Anesthesia121 participants
Secondary

Time to Active Labor

Time frame: Start of induction to active labor

ArmMeasureValue (MEDIAN)
Cervical Foley & MisoprostolTime to Active Labor7.4 Hours
Misoprostol OnlyTime to Active Labor13.3 Hours
Cervical Foley AloneTime to Active Labor11.0 Hours
Cervical Foley & PitocinTime to Active Labor8.1 Hours

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026