N/A
N=201
FOLCROM Trial: Foley Catheter in Rupture of Membranes
Premature Rupture of Membranes
Bottom Line
View on ClinicalTrials.gov: NCT01973036 ↗Enrolled (actual)
201
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcome: Primary: Time From Induction of Labor Until Delivery — 14.4; 13.9 hours
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Foley Catheter (Device); Oxytocin (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Geisinger Clinic
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From Induction of Labor Until Delivery |
14.4; 13.9 | — |
| SECONDARY Number of Participants With Chorioamnionitis |
2; 9; 0; 7 | — |
| SECONDARY Number of Participants With Vaginal Delivery Within 12 Hours From Placement of Foley Catheter or Start Time of Oxytocin |
46; 34 | — |
| SECONDARY Number of Participants With Vaginal Delivery Within 24 Hours From Placement of Foley Catheter or Start Time of Oxytocin |
80; 61 | — |
| SECONDARY Duration of First, Second and Third Stage of Labor (Minutes) for Those Undergoing Vaginal Deliveries |
130; 188; 39; 23; 5; 5 | — |
| SECONDARY Rate of Failed Induction of Labor as the Indication for Cesarean |
6; 8 | — |
| SECONDARY Rate of Endomyometritis |
0; 0 | — |
| SECONDARY Maternal Length of Stay, From Admission to Discharge (Days) |
3; 3 | — |
| SECONDARY Rate of Five Minute Apgar Score < 5 |
1; 1 | — |
| SECONDARY Arterial Cord Blood Gas (pH), When Obtained |
7.25; 7.26 | — |
| SECONDARY Rate of Neonatal Sepsis |
0; 0 | — |
| SECONDARY Neonatal Intensive Care Unit (NICU) Admission Rate |
20; 21 | — |
| SECONDARY Neonatal Length of Stay |
49.7; 52.4 | — |
| SECONDARY Number of Participants With Confirmed Histologic Chorioamnionitis/Funisitis |
9; 10 | — |
| SECONDARY Time From Induction to Delivery (Hours) |
14.23; 14.16 | — |
| SECONDARY Overall Cesarean Delivery |
21; 25 | — |
| SECONDARY Rate of Chorioamnionitis |
0; 7 | — |
| SECONDARY Maternal Length of Stay From Delivery to Discharge (Hours) |
48.1; 47.8 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
- Unfavorable cervix, defined as sterile digital exam ≤ 2cm dilated / 80% effaced
- Gestational age ≥ 34 weeks by best obstetric estimate
- Clinical management decision is vaginal delivery
- Singleton gestation
- Cephalic presentation
- Willing to participate and able to understand and sign the informed consent document before randomization
- Women of reproductive age
Exclusion Criteria
- Multiple gestations
- Lethal fetal anomalies, e.g., anencephaly, trisomy 13, trisomy 18
- Latex allergy
- Greater than 1 prior cesarean delivery
- 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.
- Suspicion of chorioamnionitis
- Any contraindications to vaginal delivery, including malpresentation, active herpes, complete placenta previa, greater than two prior cesarean deliveries, etc.
- HIV positive status or AIDS
- Intrauterine fetal demise
- Suspected placental abruption, significant hemorrhage
- Nonreassuring fetal heart rate (FHR) pattern
- Participation in a competing trial
Data sourced from ClinicalTrials.gov (NCT01973036). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.