FOLCROM Trial: Foley Catheter in Rupture of Membranes

Premature Rupture of Membranes Clinical Trial

— FOLCROM  

Official title:

Foley Catheter Versus Oxytocin for Labor Induction in Women With Term and Near Term Premature Rupture of Membranes: A Randomized Clinical Trial (FOLCROM Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01973036
• Other study ID #: 2013-0379
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: August 2016

Study information

• Verified date: July 2018
• Source: Geisinger Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Multicenter randomized clinical trial comparing oxytocin versus oxytocin and foley catheter for induction in women who present with premature rupture of membranes who are not in labor.

Description:

This is a prospective, randomized, multi-center clinical trial to test the hypothesis that in women with term and near term premature rupture of membranes (PROM), an intrauterine Foley catheter plus oxytocin infusion will decrease the mean time from induction to delivery by 2.5 hours as compared to oxytocin alone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Spontaneous rupture of membranes (ROM) =1 hour prior to starting induction; ROM defined as clinical history with the presence of 2 of the following 4: pooling, ferning, nitrazine, oligohydramnios. In the absence of clinical history, oligohydramnios AND pooling must be present for ROM to be diagnosed. Oligohydramnios is defined as a total amniotic fluid index of <5cm or a maximum vertical pocket <2cm.

2. Unfavorable cervix, defined as sterile digital exam = 2cm dilated / 80% effaced

3. Gestational age = 34 weeks by best obstetric estimate

4. Clinical management decision is vaginal delivery

5. Singleton gestation

6. Cephalic presentation

7. Willing to participate and able to understand and sign the informed consent document before randomization

8. Women of reproductive age

Exclusion Criteria:

1. Multiple gestations

2. Lethal fetal anomalies, e.g., anencephaly, trisomy 13, trisomy 18

3. Latex allergy

4. Greater than 1 prior cesarean delivery

5. Active labor - defined as contractions more frequent than every 5 minutes (or = 12 contractions in 1 hour) associated with = 1 cm cervical change. In the absence of = 1 cm cervical change after 2 hours, patients with contractions can be included in the study.

6. Suspicion of chorioamnionitis

7. Any contraindications to vaginal delivery, including malpresentation, active herpes, complete placenta previa, greater than two prior cesarean deliveries, etc.

8. HIV positive status or AIDS

9. Intrauterine fetal demise

10. Suspected placental abruption, significant hemorrhage

11. Nonreassuring fetal heart rate (FHR) pattern

12. Participation in a competing trial

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Premature Birth
• Premature Rupture of Membranes
• Rupture

Intervention

Device:
• Foley Catheter
The balloon will be inflated with 30 cc of sterile saline. The catheter will be taped to the patient's leg so that traction is maintained. The catheter will be assessed hourly for expulsion by a health care provider by applying gentle traction on the catheter or a vaginal examination if it is unclear by traction. Once the Foley catheter is expelled or 12 hours reached, the induction will be continued with oxytocin per this protocol.

Drug:
• Oxytocin
Each arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.

Locations

Country	Name	City	State
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Christiana Care Health System CCHS	Newark	Delaware
United States	Banner Good Samaritan Regional Medical Center	Phoenix	Arizona
United States	Geisinger Wyoming Valley	Wilkes-Barre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Geisinger Clinic

Country where clinical trial is conducted

United States, 

References & Publications (14)

ACOG Committee on Practice Bulletins -- Obstetrics. ACOG Practice Bulletin No. 107: Induction of labor. Obstet Gynecol. 2009 Aug;114(2 Pt 1):386-97. doi: 10.1097/AOG.0b013e3181b48ef5. Review. — View Citation

Boulvain M, Kelly A, Lohse C, Stan C, Irion O. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2001;(4):CD001233. Review. Update in: Cochrane Database Syst Rev. 2012;3:CD001233. — View Citation

Fitzpatrick CB, Grotegut CA, Bishop TS, Canzoneri BJ, Heine RP, Swamy GK. Cervical ripening with foley balloon plus fixed versus incremental low-dose oxytocin: a randomized controlled trial. J Matern Fetal Neonatal Med. 2012 Jul;25(7):1006-10. doi: 10.310 — View Citation

Gunn GC, Mishell DR Jr, Morton DG. Premature rupture of the fetal membranes. A review. Am J Obstet Gynecol. 1970 Feb 1;106(3):469-83. Review. — View Citation

Hannah ME, Ohlsson A, Farine D, Hewson SA, Hodnett ED, Myhr TL, Wang EE, Weston JA, Willan AR. Induction of labor compared with expectant management for prelabor rupture of the membranes at term. TERMPROM Study Group. N Engl J Med. 1996 Apr 18;334(16):100 — View Citation

LANIER LR Jr, SCARBROUGH RW Jr, FILLINGIM DW, BAKER RE Jr. INCIDENCE OF MATERNAL AND FETAL COMPLICATIONS ASSOCIATED WITH RUPTURE OF THE MEMBRANES BEFORE ONSET OF LABOR. Am J Obstet Gynecol. 1965 Oct 1;93:398-404. — View Citation

Lin MG, Nuthalapaty FS, Carver AR, Case AS, Ramsey PS. Misoprostol for labor induction in women with term premature rupture of membranes: a meta-analysis. Obstet Gynecol. 2005 Sep;106(3):593-601. — View Citation

Oliveira MV, Oberst PV, Leite GK, Aguemi A, Kenj G, Leme VD, Sass N. [Cervical Foley catheter versus vaginal misoprostol for cervical ripening and induction of labor: a randomized clinical trial]. Rev Bras Ginecol Obstet. 2010 Jul;32(7):346-51. Portuguese — View Citation

Pettker CM, Pocock SB, Smok DP, Lee SM, Devine PC. Transcervical Foley catheter with and without oxytocin for cervical ripening: a randomized controlled trial. Obstet Gynecol. 2008 Jun;111(6):1320-6. doi: 10.1097/AOG.0b013e31817615a0. — View Citation

Sanchez-Ramos L, Chen AH, Kaunitz AM, Gaudier FL, Delke I. Labor induction with intravaginal misoprostol in term premature rupture of membranes: a randomized study. Obstet Gynecol. 1997 Jun;89(6):909-12. — View Citation

Tan PC, Daud SA, Omar SZ. Concurrent dinoprostone and oxytocin for labor induction in term premature rupture of membranes: a randomized controlled trial. Obstet Gynecol. 2009 May;113(5):1059-65. doi: 10.1097/AOG.0b013e3181a1f605. — View Citation

Wing DA, Paul RH. Induction of labor with misoprostol for premature rupture of membranes beyond thirty-six weeks' gestation. Am J Obstet Gynecol. 1998 Jul;179(1):94-9. — View Citation

Wolff K, Swahn ML, Westgren M. Balloon catheter for induction of labor in nulliparous women with prelabor rupture of the membranes at term. A preliminary report. Gynecol Obstet Invest. 1998;46(1):1-4. — View Citation

Zeteroglu S, Engin-Ustün Y, Ustün Y, Güvercinçi M, Sahin G, Kamaci M. A prospective randomized study comparing misoprostol and oxytocin for premature rupture of membranes at term. J Matern Fetal Neonatal Med. 2006 May;19(5):283-7. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time From Induction of Labor Until Delivery	Time from induction (i.e., start time of Foley catheter or oxytocin) to delivery (hours), analyzed for all deliveries	Time from induction to delivery (average 14.2 hours)
Secondary	Number of Participants With Chorioamnionitis	Number of participants with chorioamnionitis excluding all those who were hospitalized with preterm premature rupture of membranes (PPROM) prior to 34 0/7 weeks. Chorioamnionitis was defined as temperature 38°C (or 100.4°F) or greater with at least two of the following: purulent discharge, maternal tachycardia (heart rate 100 beats per minute or greater), fetal tachycardia (heart rate 160 beats per minute or greater), foul odor of the amniotic fluid, or maternal leukocytosis (greater than 15,000 cells/mL3).; Without Restriction = Chorioamnionitis was defined as temperature 38°C or greater and one of the following: purulent discharge, maternal tachycardia, fetal tachycardia, foul odor of the amniotic fluid, or maternal leukocytosis.; With Restriction = Chorioamnionitis was defined as temperature 38°C or greater and two of the following: purulent discharge, maternal tachycardia, fetal tachycardia, foul odor of the amniotic fluid, or maternal leukocytosis.	Duration of Labor (average 4.8 hours)
Secondary	Number of Participants With Vaginal Delivery Within 12 Hours From Placement of Foley Catheter or Start Time of Oxytocin		Duration of Labor (average 4.8 hours)
Secondary	Number of Participants With Vaginal Delivery Within 24 Hours From Placement of Foley Catheter or Start Time of Oxytocin		Duration of Labor (average 4.8 hours)
Secondary	Duration of First, Second and Third Stage of Labor (Minutes) for Those Undergoing Vaginal Deliveries		Duration of Labor (average 4.8 hours)
Secondary	Rate of Failed Induction of Labor as the Indication for Cesarean	This will be defined by a combination of provider documentation and cervical dilation of =4cm/90% effaced or =5cm/any effacement after a minimum of 12 hours of oxytocin in the setting of adequate contraction.; One patient was missing information for failed induction.	Duration of Labor (average 4.8 hours)
Secondary	Rate of Endomyometritis	Endomyometritis defined as: Temperature =100.4°F + one of the following: fundal tenderness, maternal tachycardia (Heart Rate = 100 BPM), purulent cervical discharge and no other source of fever	Duration of hospital stay (average 3.4 days)
Secondary	Maternal Length of Stay, From Admission to Discharge (Days)		Duration of hospital stay (average 3.4 days)
Secondary	Rate of Five Minute Apgar Score < 5	Apgar is a test for assessing a newborn shortly after birth to determine if extra medical care or emergency care may be needed. Usually administered at 1 and 5 minutes after birth, the test includes assessment of Appearance, Pulse, Grimace, Activity and Respiration. Scores range from 0 - 10.	Duration of hospital stay (average 3.4 days)
Secondary	Arterial Cord Blood Gas (pH), When Obtained		Within 1 hour of delivery
Secondary	Rate of Neonatal Sepsis	Neonatal sepsis [positive blood or cerebrospinal fluid (CSF) cultures]	Duration of hospital stay (average 3.4 days)
Secondary	Neonatal Intensive Care Unit (NICU) Admission Rate		Duration of hospital stay (average 3.4 days)
Secondary	Neonatal Length of Stay		Duration of hospital stay (average 3.4 days)
Secondary	Number of Participants With Confirmed Histologic Chorioamnionitis/Funisitis	Chorioamnionitis/funisitis as determined by the pathologist examining the placenta	Duration of hospital stay (average 3.4 days)
Secondary	Time From Induction to Delivery (Hours)	Time from induction to delivery (hours) excluding all those who were hospitalized with PPROM prior to 34 0/7 weeks	Time from induction to delivery (average 14.2 hours)
Secondary	Overall Cesarean Delivery		Duration of hospital stay (average 3.4 days)
Secondary	Rate of Chorioamnionitis	Chorioamnionitis defined as (Temperature greater than or equal to 100.4 degrees fahrenheit or 38 degrees celsius) with at least 2 of the following: uterine tenderness, maternal tachycardia (HR greater than or equal to 100 bpm), fetal tachycardia (HR greater than or equal to 160bpm), foul odor of the amniotic fluid, or maternal leukocytosis (greater than 15000 cells/cubic milliliter)	Duration of hospital stay (average 3.4 days)
Secondary	Maternal Length of Stay From Delivery to Discharge (Hours)		Duration of hospital stay (average 3.4 days)