Overview

This trial is active, not recruiting.

Condition premature rupture of membranes
Treatments foley catheter, oxytocin
Sponsor Geisinger Clinic
Start date March 2014
End date December 2016
Trial size 201 participants
Trial identifier NCT01973036, 2013-0379

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
This 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.
oxytocin Pitocin
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.
(Experimental)
A 30cc/16 French (16F) foley catheter will be inserted by the provider under direct visualization or by palpation, ensuring that the catheter is appropriately and adequately positioned. Oxytocin will be administered concurrently at a rate of 2 milliunits/milliliter (as noted under oxytocin active comparator). If the catheter remains in place after 12 hours, it will be deflated and removed and oxytocin infusion will continue.
foley catheter 30cc/16 French
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.
oxytocin Pitocin
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.

Primary Outcomes

Measure
Time from induction of labor until delivery
time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days

Secondary Outcomes

Measure
Rate of chorioamnionitis excluding all those who were hospitalized with preterm premature rupture of membranes (PPROM) prior to 34 0/7 weeks
time frame: Duration of Labor, an average of 24 hours
Rate of vaginal delivery within 12 hours from placement of Foley catheter or start time of oxytocin
time frame: Duration of Labor, an average of 24 hours
Rate of vaginal delivery within 24 hours from placement of Foley catheter or start time of oxytocin
time frame: Duration of Labor, an average of 24 hours
Duration of first, second and third stage of labor (minutes) for those undergoing vaginal deliveries
time frame: Duration of Labor, an average of 24 hours
Rate of failed induction of labor as the indication for cesarean
time frame: Duration of Labor, an average of 24 hours
Rate of Endomyometritis
time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Maternal length of stay, from admission to discharge and from delivery to discharge
time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Rate of five minute Apgar score < 5
time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Arterial Cord blood gas (pH), when obtained
time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Rate of Neonatal Sepsis
time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Neonatal Intensive Care Unit (NICU) admission rate
time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Neonatal length of stay
time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Histologic chorioamnionitis/funisitis
time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Time from induction to delivery (minutes) excluding all those who were hospitalized with PPROM prior to 34 0/7 weeks
time frame: Duration of Labor, and average of 24 hours
Overall Cesarean Delivery
time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Rate of Chorioamnionitis
time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days

Eligibility Criteria

Female participants of any age.

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

Additional Information

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)
Principal investigator Awathif D Mackeen, MD, MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Geisinger Clinic.