Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03086967
Other study ID # 06-13-03B
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2013
Est. completion date February 2016

Study information

Verified date March 2017
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The Foley catheter is a safe, effective method for cervical ripening. Limited data exists to indicate ideal time of placement for optimal cervical ripening prior to induction. The proposed study is a randomized control trial to determine if shortening placement from 12 to 6 hours of foley catheter can decrease time from start of induction to delivery. The prediction is that shortening foley bulb placement will result in shorter induction times, increased patient satisfaction and decreased length of stay on labor and delivery with secondary decreased medical costs.


Description:

Objective: To determine whether a double-lumen balloon catheter requires twelve hours in the cervical canal to achieve its maximal cervical dilation. It is the hypothesis that the maximum cervical dilation and benefits of a double lumen foley catheter are achieved within the initial six hours after placement. Study Design: Overview: All eligible patients with a singleton pregnancy at 37 weeks gestational age or greater who are presenting for a clinically/ medically indicated induction with an unfavorable cervical exam will be invited to participate. As per the American College of Obstetricians and Gynecologists (ACOG) guidelines, all inductions performed prior to 39 weeks are medically indicated. Medical indications for induction prior to 39 weeks include but are not limited to preeclampsia, oligohydramnios and growth restriction. Upon admission to Labor and Delivery, women will be assessed for eligibility by an obstetric physician. A digital cervical examination will be performed and a Bishop score assigned. Patients with a Bishop score ≤ 6 are thought to benefit from a cervical ripening agent and the participants will be randomized based on parity at this point. Type of Study: This study will be a prospective, randomized clinical control trial with human subjects. Materials and Methods: A qualified obstetric provider will provide eligible women with details of the study, including study objectives and methods. Consent will be obtained and witnessed from patients who elect to participate. Enrollment and randomization in the study will then occur. Patients will be randomized to the two groups using computer generated random numbers. The randomization will be stratified based on parity (i.e., women who have had any prior vaginal delivery above 20 weeks gestation v. women who have not). A foley bulb will then be placed by a qualified obstetric provider. Foley bulb will be inserted with or without speculum technique and with or without use of a stylet. In accordance with the standard of care, sterile saline will be placed in the intrauterine and vaginal balloon as tolerated by the patient for no more than a maximum of 80 cc in each balloon. The use of concomitant low dose pitocin with the foley bulb will be at the discretion of the admitting obstetric team. If the patient's foley bulb does not spontaneously expel within the maximum allotted time, they will be manually removed at six or twelve hours. At the time of manual removal or expulsion of the foley balloon, the patient's cervix will be checked by an experienced obstetric provider. As per usual protocol, additional cervical ripening and labor induction will proceed per managing obstetric team. Independent Variables: Data collection will include the independent variables of maternal age, parity, BMI, race (Caucasian, African American, Hispanic, Asian, other), Bishop Score, use of magnesium and epidural use. Data collection of independent fetal variables will include gestational age and estimated fetal weight. Outcome Variables: The primary outcome will be time from foley bulb placement to time of delivery. Secondary outcomes will include time from foley bulb placement to extrusion and rate of cesarean section. Additional comparison variables include: neonatal weight, APGAR scores and intrapartum and postpartum infection rates.


Recruitment information / eligibility

Status Completed
Enrollment 204
Est. completion date February 2016
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender Female
Age group 16 Years to 45 Years
Eligibility Inclusion Criteria: 1. Intrauterine pregnancy at 37 weeks gestational age or greater as determined by best obstetrical dating criteria 2. Singleton gestation 3. Vertex presentation 4. Clinically adequate pelvis 5. Bishop Score less than or equal to 6 6. 16 years and older - North Carolina state law provides for the emancipation of minors, Chapter 7B-Article 35. Exclusion Criteria: 1. Any maternal or fetal contraindication to vaginal delivery 2. Known uterine anomaly 3. Multifetal gestation 4. Estimated fetal weight of 4500 gm or greater 5. Ruptured membranes

Study Design


Related Conditions & MeSH terms

  • Induction of Labor Affected Fetus / Newborn

Intervention

Device:
Double-lumen balloon catheter
introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices

Locations

Country Name City State
United States Carolinas Medical Center Charlotte North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time From Foley Bulb Placement to Time of Delivery. Time in hours to delivery following use of foley catheter Change in time to delivery following bulb insertion for 6 hours up to 72 hours
Primary Time to Delivery of Trial of Labor After Cesarean Section Time (hours) to delivery
Primary 1 Minute Apgar Score of Trial of Labor After Cesarean Section The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health. 1 minute Apgar score following birth
Secondary Time From Foley Bulb Placement to Extrusion Time in hours from foley bulb placement to extrusion Hour 6, Hour 12
Secondary Mode of Delivery--Number of Participants Having Cesarean Delivery Hour Six, Hour 12
Secondary Bacterial Infection (Chorioamnionitis) Hour Six, Hour 12
Secondary Endometritis Hour 6, Hour 12
Secondary 1 Minute Apgar Score The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health. 1 minute Apgar score following birth
Secondary 5 Minute Apgar Score The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health. 5 minute Apgar score following birth
Secondary Time to Foley Bulb Extrusion of Trial of Labor After Cesarean Section Time to foley bulb extrusion
Secondary 5 Minute Apgar Score of Trial of Labor After Cesarean Section The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health. 5 Minute Apgar Score following birth
See also
  Status Clinical Trial Phase
Recruiting NCT04492150 - Effect of Glucose 5% on Labor Length N/A
Not yet recruiting NCT03625518 - Mode of Induction in Fetal Growth Restriction and Its Affects on Fetal and Maternal Outcomes Early Phase 1
Completed NCT04496908 - Early Versus Delayed Artificial Rupture of Membranes (AROM Trial) Early Phase 1
Recruiting NCT04478942 - PROMMO Trial: Oral Misoprostol vs IV Oxytocin Early Phase 1
Completed NCT04597333 - Labor Induction After Failed Induction With Dinoprostone. N/A
Completed NCT03682718 - Vaginal Misoprostol With Intracervical Foley Catheter in Induction of Labor Phase 4
Recruiting NCT03533699 - A Comparison Between the Effect of Oxytocin Only and Oxytocin Plus Propranolol on Induction of Labor in Term Pregnancy N/A
Recruiting NCT05187247 - VR Glasses During Induction of Labour for Pain and Anxiety Relieve N/A
Active, not recruiting NCT02975167 - Patient Satisfaction During Outpatient Versus Inpatient Foley Catheter Induction of Labor N/A
Recruiting NCT05079841 - The Stimulation To Induce Mothers Study Phase 4
Not yet recruiting NCT06375746 - The Impact of a Customized Informative Video Prior to Induction of Labor on Anxiety Relieve - a Randomized Controlled Trial Phase 3
Completed NCT03822052 - The Use of D5LR Versus LR for Induction of Labor and Time to Delivery in Multiparous and Primiparous Patient's With Favorable and Unfavorable Bishop's Scores N/A
Completed NCT04220320 - The Success of Labor Induction Based on a Modified BISHOP Score.
Withdrawn NCT04739683 - Cervical Ripening With Foley Bulb Versus Dilapan-S at Home N/A
Completed NCT04299854 - Modality of Induction of Labor in Obese Women at Term (MODOBAT)
Completed NCT03944187 - Sonographic Assessment for Prediction of Labor Induction Success
Recruiting NCT03928899 - The Best Timing of Delivery in Women With GDM Study N/A
Not yet recruiting NCT04350437 - Induction Of Labor: Predictors of Outcomes N/A
Terminated NCT04011098 - Improving Labour Induction Analgesia: Epidural Fentanyl Bolus at Epidural Initiation for Induction of Labour Phase 1
Completed NCT02952807 - Vaginal Misoprostol and Foley Catheter for Induction of Labor Phase 2