Clinical Trials Logo

Clinical Trial Summary

A randomized, prospective trial will be offered to women admitted to the Roosevelt Hospital labor floor for labor induction. The hypothesis is that the simultaneous use of a foley bulb together with vaginal misoprostol will result in shorter induction to delivery time compared with vaginal misoprostol alone


Clinical Trial Description

1. Objectives The hypothesis is that cervical ripening using a foley bulb together with vaginal misoprostol (cytotec) will result in shorter induction to delivery time compared with vaginal misoprostol alone

2. Background The rate of induction of labor in the United States is approximately 20% of all births. Induction of labor can result in prolonged labor and increases the rate of cesarean delivery, both of which are associated with increased maternal and neonatal morbidity. Ripening of an unfavorable cervix has become an integral part of the labor induction process. The best method of cervical ripening remains controversial; no one method has proved to be superior. Women requiring labor induction often present with unfavorable cervices which can lead to a prolonged induction. Cervical ripening is often done to increase the likelihood of successful labor induction.

Misoprostol (cytotec) is PGE1 analog and widely used for cervical ripening and is the preferred method of induction of labor based on the safety reported literature. Low-dose (25 mcg) intravaginal misoprostol appears to be safe and effective for cervical ripening in term pregnancy for patients without a history of cesarean section. Compared with other cervical ripening methods, misoprostol has an increased rate of vaginal delivery within 24 hours without significant differences in cesarean section rates or fetal outcomes.

The use of the foley catheter for induction of labor was first described by Krause in 1953. In 1967 Embrey and Mollison reported a 94% successful induction rate after using the foley catheter for cervical ripening. Since then, several studies found transcervical foley catheters as effective as prostaglandins preparations for ripening without an increased risk of uterine rupture.

There are many proposed methods for induction of labor including mechanical (transcervical foley bulb) and chemical methods (prostaglandins, oxytocin). A number of randomized trials have compared the use of foley bulb, oxytocin and misoprostol in different combinations for induction of labor and their results are contradictory with regards to induction to delivery time, successful vaginal delivery and labor complications.

There are two studies that evaluated the foley bulb with misoprostol comparing to misoprostol alone. Carbone el al study, found the mean induction to delivery time was 3 hours shorter with the combination of the foley bulb and vaginal misoprostol when compared to vaginal misoprostol alone. In a study by Chung et al, there was no difference in the induction to delivery time.

Therefore given the contradicting results regarding induction of labor using foley bulb with misoprostol or misoprostol alone, the purpose of our study is to determine if there is a decrease in the induction to delivery time with one method versus the other.

3. Setting of the Human Research Research will take place on the labor and delivery floor of Roosevelt Hospital

4. Study Design a) Recruitment Methods Women admitted to labor and delivery at Roosevelt Hospital will be asked to participate in the study if they are to have an induction of labor at or beyond term (37weeks of gestation). Patients will be screened and those meeting the eligibility criteria will be approached. Informed consent will be obtained.

After a discussion about the study with an eligible interested subject, an investigator will review the consent with them. The investigator will give the potential subject the opportunity to ask any questions and have them answered. Potential participants will be given the opportunity to think about the study. (Only those investigators listed as study personnel and authorized to obtain consent, will obtain informed consent). Once a patient wishes to join the study and informed consent is obtained, the subject can participate. Each subject will receive a signed copy of the consent form. The subject can withdraw from the study at any time without any retribution. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02566005
Study type Interventional
Source St. Luke's-Roosevelt Hospital Center
Contact
Status Completed
Phase N/A
Start date September 2015
Completion date July 2016

See also
  Status Clinical Trial Phase
Completed NCT03442582 - Afluria Pregnancy Registry
Terminated NCT02161861 - Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study N/A
Not yet recruiting NCT05934318 - L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE) N/A
Enrolling by invitation NCT05415371 - Persistent Poverty Counties Pregnant Women With Medicaid N/A
Completed NCT04548102 - Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman N/A
Completed NCT03218956 - Protein Requirement During Lactation N/A
Completed NCT02191605 - Computer-delivered Screening & Brief Intervention for Marijuana Use in Pregnancy N/A
Completed NCT02223637 - Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
Recruiting NCT06049953 - Maternal And Infant Antipsychotic Study
Active, not recruiting NCT02577536 - PregSource: Crowdsourcing to Understand Pregnancy
Not yet recruiting NCT04786587 - Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
Not yet recruiting NCT05412238 - Formulation and Evaluation of the Efficacy of Macro- and Micronutrient Sachets on Pregnant Mothers and Children Aged 6-60 Months N/A
Not yet recruiting NCT05028387 - Telemedicine Medical Abortion Service Using the "No-test" Protocol in Ukraine and Uzbekistan.
Completed NCT02683005 - Study of Hepatitis C Treatment During Pregnancy Phase 1
Completed NCT02783170 - Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women Phase 4
Recruiting NCT02507180 - Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer
Recruiting NCT02564250 - Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women N/A
Recruiting NCT02619188 - Nutritional Markers in Normal and Hyperemesis Pregnancies N/A
Completed NCT02520687 - Effects of Dietary Nitrate in Hypertensive Pregnant Women Phase 1
Completed NCT02408315 - Induction With Misoprostol: Oral Mucosa Versus Vaginal Epithelium (IMPROVE) Phase 3