Clinical trial NCT01973036: FOLCROM Trial: Foley Catheter in Rupture of Membranes
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Rupture of Membranes
Keywords: foley catheter
foley bulb
oxytocin
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2013-10-31
Enrollment: 201
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time From Induction of Labor Until Delivery
timeFrame: Time from induction to delivery (average 14.2 hours)
Secondary outcomes:
measure: Number of Participants With Chorioamnionitis
timeFrame: Duration of Labor (average 4.8 hours)
measure: Number of Participants With Vaginal Delivery Within 12 Hours From Placement of Foley Catheter or Start Time of Oxytocin
timeFrame: Duration of Labor (average 4.8 hours)
measure: Number of Participants With Vaginal Delivery Within 24 Hours From Placement of Foley Catheter or Start Time of Oxytocin
timeFrame: Duration of Labor (average 4.8 hours)
measure: Duration of First, Second and Third Stage of Labor (Minutes) for Those Undergoing Vaginal Deliveries
timeFrame: Duration of Labor (average 4.8 hours)
measure: Rate of Failed Induction of Labor as the Indication for Cesarean
timeFrame: Duration of Labor (average 4.8 hours)
measure: Rate of Endomyometritis
timeFrame: Duration of hospital stay (average 3.4 days)
measure: Maternal Length of Stay, From Admission to Discharge (Days)
timeFrame: Duration of hospital stay (average 3.4 days)
measure: Rate of Five Minute Apgar Score < 5
timeFrame: Duration of hospital stay (average 3.4 days)
measure: Arterial Cord Blood Gas (pH), When Obtained
timeFrame: Within 1 hour of delivery
measure: Rate of Neonatal Sepsis
timeFrame: Duration of hospital stay (average 3.4 days)
measure: Neonatal Intensive Care Unit (NICU) Admission Rate
timeFrame: Duration of hospital stay (average 3.4 days)
measure: Neonatal Length of Stay
timeFrame: Duration of hospital stay (average 3.4 days)
measure: Number of Participants With Confirmed Histologic Chorioamnionitis/Funisitis
timeFrame: Duration of hospital stay (average 3.4 days)
measure: Time From Induction to Delivery (Hours)
timeFrame: Time from induction to delivery (average 14.2 hours)
measure: Overall Cesarean Delivery
timeFrame: Duration of hospital stay (average 3.4 days)
measure: Rate of Chorioamnionitis
timeFrame: Duration of hospital stay (average 3.4 days)
measure: Maternal Length of Stay From Delivery to Discharge (Hours)
timeFrame: Duration of hospital stay (average 3.4 days)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Good Samaritan Regional Medical Center
state: Arizona
city: Newark
country: United States
facility: Christiana Care Health System CCHS
state: Delaware
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Geisinger Wyoming Valley
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Awathif D Mackeen, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: ACOG Practice Bulletin No. 107: Induction of labor. Obstet Gynecol. 2009 Aug;114(2 Pt 1):386-397. doi: 10.1097/AOG.0b013e3181b48ef5. No abstract available.
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. doi: 10.1016/0002-9378(70)90378-9. No abstract available.
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. doi: 10.1016/0002-9378(65)90068-2. No abstract available.
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citation: Boulvain M, Kelly A, Lohse C, Stan C, Irion O. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2001;(4):CD001233. doi: 10.1002/14651858.CD001233.
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):1005-10. doi: 10.1056/NEJM199604183341601.
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: 10.3109/14767058.2011.607522. Epub 2011 Dec 14.
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.
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. doi: 10.1590/s0100-72032010000700007. Portuguese.
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. doi: 10.1016/s0029-7844(97)00113-0.
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. doi: 10.1016/s0002-9378(98)70256-x.
citation: Zeteroglu S, Engin-Ustun Y, Ustun Y, Guvercinci 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. doi: 10.1080/14767050600589807.
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):1059-1065. doi: 10.1097/AOG.0b013e3181a1f605.
citation: Mackeen AD, Durie DE, Lin M, Huls CK, Qureshey E, Paglia MJ, Sun H, Sciscione A. Foley Plus Oxytocin Compared With Oxytocin for Induction After Membrane Rupture: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jan;131(1):4-11. doi: 10.1097/AOG.0000000000002374.