Premature Rupture of Membranes
Conditions
Keywords
foley catheter, foley bulb, oxytocin
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.
Interventions
DEVICEFoley 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.
DRUGOxytocin
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.
Sponsors
Geisinger Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time From Induction of Labor Until Delivery | Time from induction to delivery (average 14.2 hours) | Time from induction (i.e., start time of Foley catheter or oxytocin) to delivery (hours), analyzed for all deliveries |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
| 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) | — |
| Duration of First, Second and Third Stage of Labor (Minutes) for Those Undergoing Vaginal Deliveries | Duration of Labor (average 4.8 hours) | — |
| Rate of Failed Induction of Labor as the Indication for Cesarean | Duration of Labor (average 4.8 hours) | 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. |
| Rate of Endomyometritis | Duration of hospital stay (average 3.4 days) | 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 |
| Maternal Length of Stay, From Admission to Discharge (Days) | Duration of hospital stay (average 3.4 days) | — |
| Rate of Five Minute Apgar Score < 5 | Duration of hospital stay (average 3.4 days) | 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. |
| Arterial Cord Blood Gas (pH), When Obtained | Within 1 hour of delivery | — |
| Number of Participants With Chorioamnionitis | Duration of Labor (average 4.8 hours) | 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. |
| Neonatal Intensive Care Unit (NICU) Admission Rate | Duration of hospital stay (average 3.4 days) | — |
| Neonatal Length of Stay | Duration of hospital stay (average 3.4 days) | — |
| Number of Participants With Confirmed Histologic Chorioamnionitis/Funisitis | Duration of hospital stay (average 3.4 days) | Chorioamnionitis/funisitis as determined by the pathologist examining the placenta |
| Time From Induction to Delivery (Hours) | Time from induction to delivery (average 14.2 hours) | Time from induction to delivery (hours) excluding all those who were hospitalized with PPROM prior to 34 0/7 weeks |
| Overall Cesarean Delivery | Duration of hospital stay (average 3.4 days) | — |
| Rate of Chorioamnionitis | Duration of hospital stay (average 3.4 days) | 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) |
| Maternal Length of Stay From Delivery to Discharge (Hours) | Duration of hospital stay (average 3.4 days) | — |
| Rate of Neonatal Sepsis | Duration of hospital stay (average 3.4 days) | Neonatal sepsis \[positive blood or cerebrospinal fluid (CSF) cultures\] |
Countries
United States
Participant flow
Recruitment details
Women presenting to labor & delivery with ruptured membranes with an unfavorable cervix based on sterile digital exam at greater than or equal to 34 weeks were approached by a study team member for participation.
Participants by arm
| Arm | Count |
|---|---|
| Oxytocin 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: 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. | 108 |
| Foley Catheter and Oxytocin 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: 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: Each arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuri | 93 |
| Total | 201 |
Baseline characteristics
| Characteristic | Oxytocin | Foley Catheter and Oxytocin | Total |
|---|---|---|---|
| Age, Continuous | 27 years | 27.5 years | 27.25 years |
| Sex: Female, Male Female | 108 Participants | 93 Participants | 201 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 108 | 0 / 93 |
| other Total, other adverse events | 0 / 108 | 0 / 93 |
| serious Total, serious adverse events | 0 / 108 | 0 / 93 |
Outcome results
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 frame: Time from induction to delivery (average 14.2 hours)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin | Time From Induction of Labor Until Delivery | 14.4 hours | Standard Deviation 7.9 |
| Foley Catheter and Oxytocin | Time From Induction of Labor Until Delivery | 13.9 hours | Standard Deviation 6.9 |
Secondary
Arterial Cord Blood Gas (pH), When Obtained
Time frame: Within 1 hour of delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin | Arterial Cord Blood Gas (pH), When Obtained | 7.25 pH | Standard Deviation 0.07 |
| Foley Catheter and Oxytocin | Arterial Cord Blood Gas (pH), When Obtained | 7.26 pH | Standard Deviation 0.07 |
Secondary
Duration of First, Second and Third Stage of Labor (Minutes) for Those Undergoing Vaginal Deliveries
Time frame: Duration of Labor (average 4.8 hours)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Oxytocin | Duration of First, Second and Third Stage of Labor (Minutes) for Those Undergoing Vaginal Deliveries | First Stage | 130 Minutes |
| Oxytocin | Duration of First, Second and Third Stage of Labor (Minutes) for Those Undergoing Vaginal Deliveries | Second Stage | 39 Minutes |
| Oxytocin | Duration of First, Second and Third Stage of Labor (Minutes) for Those Undergoing Vaginal Deliveries | Third Stage | 5 Minutes |
| Foley Catheter and Oxytocin | Duration of First, Second and Third Stage of Labor (Minutes) for Those Undergoing Vaginal Deliveries | First Stage | 188 Minutes |
| Foley Catheter and Oxytocin | Duration of First, Second and Third Stage of Labor (Minutes) for Those Undergoing Vaginal Deliveries | Second Stage | 23 Minutes |
| Foley Catheter and Oxytocin | Duration of First, Second and Third Stage of Labor (Minutes) for Those Undergoing Vaginal Deliveries | Third Stage | 5 Minutes |
Secondary
Maternal Length of Stay, From Admission to Discharge (Days)
Time frame: Duration of hospital stay (average 3.4 days)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Oxytocin | Maternal Length of Stay, From Admission to Discharge (Days) | 3 days |
| Foley Catheter and Oxytocin | Maternal Length of Stay, From Admission to Discharge (Days) | 3 days |
Secondary
Maternal Length of Stay From Delivery to Discharge (Hours)
Time frame: Duration of hospital stay (average 3.4 days)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Oxytocin | Maternal Length of Stay From Delivery to Discharge (Hours) | 48.1 hours |
| Foley Catheter and Oxytocin | Maternal Length of Stay From Delivery to Discharge (Hours) | 47.8 hours |
Secondary
Neonatal Intensive Care Unit (NICU) Admission Rate
Time frame: Duration of hospital stay (average 3.4 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oxytocin | Neonatal Intensive Care Unit (NICU) Admission Rate | 20 Participants |
| Foley Catheter and Oxytocin | Neonatal Intensive Care Unit (NICU) Admission Rate | 21 Participants |
Secondary
Neonatal Length of Stay
Time frame: Duration of hospital stay (average 3.4 days)
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Oxytocin | Neonatal Length of Stay | 49.7 hours | Standard Deviation 16.9 |
| Foley Catheter and Oxytocin | Neonatal Length of Stay | 52.4 hours | Standard Deviation 20 |
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.
Time frame: Duration of Labor (average 4.8 hours)
Population: The number of participants analyzed excludes patients who were hospitalized with PPROM prior to 34 0/7 weeks (i.e., four patients in the Oxytocin arm and six patients in the Foley Catheter arm).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oxytocin | Number of Participants With Chorioamnionitis | Without Restrictions | 2 Participants |
| Oxytocin | Number of Participants With Chorioamnionitis | With Restrictions | 0 Participants |
| Foley Catheter and Oxytocin | Number of Participants With Chorioamnionitis | Without Restrictions | 9 Participants |
| Foley Catheter and Oxytocin | Number of Participants With Chorioamnionitis | With Restrictions | 7 Participants |
Secondary
Number of Participants With Confirmed Histologic Chorioamnionitis/Funisitis
Chorioamnionitis/funisitis as determined by the pathologist examining the placenta
Time frame: Duration of hospital stay (average 3.4 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oxytocin | Number of Participants With Confirmed Histologic Chorioamnionitis/Funisitis | 9 Participants |
| Foley Catheter and Oxytocin | Number of Participants With Confirmed Histologic Chorioamnionitis/Funisitis | 10 Participants |
Secondary
Number of Participants With Vaginal Delivery Within 12 Hours From Placement of Foley Catheter or Start Time of Oxytocin
Time frame: Duration of Labor (average 4.8 hours)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oxytocin | Number of Participants With Vaginal Delivery Within 12 Hours From Placement of Foley Catheter or Start Time of Oxytocin | 46 Participants |
| Foley Catheter and Oxytocin | Number of Participants With Vaginal Delivery Within 12 Hours From Placement of Foley Catheter or Start Time of Oxytocin | 34 Participants |
Secondary
Number of Participants With Vaginal Delivery Within 24 Hours From Placement of Foley Catheter or Start Time of Oxytocin
Time frame: Duration of Labor (average 4.8 hours)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oxytocin | Number of Participants With Vaginal Delivery Within 24 Hours From Placement of Foley Catheter or Start Time of Oxytocin | 80 Participants |
| Foley Catheter and Oxytocin | Number of Participants With Vaginal Delivery Within 24 Hours From Placement of Foley Catheter or Start Time of Oxytocin | 61 Participants |
Secondary
Overall Cesarean Delivery
Time frame: Duration of hospital stay (average 3.4 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oxytocin | Overall Cesarean Delivery | 21 Participants |
| Foley Catheter and Oxytocin | Overall Cesarean Delivery | 25 Participants |
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)
Time frame: Duration of hospital stay (average 3.4 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oxytocin | Rate of Chorioamnionitis | 0 Participants |
| Foley Catheter and Oxytocin | Rate of Chorioamnionitis | 7 Participants |
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
Time frame: Duration of hospital stay (average 3.4 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oxytocin | Rate of Endomyometritis | 0 Participants |
| Foley Catheter and Oxytocin | Rate of Endomyometritis | 0 Participants |
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.
Time frame: Duration of Labor (average 4.8 hours)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oxytocin | Rate of Failed Induction of Labor as the Indication for Cesarean | 6 Participants |
| Foley Catheter and Oxytocin | Rate of Failed Induction of Labor as the Indication for Cesarean | 8 Participants |
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.
Time frame: Duration of hospital stay (average 3.4 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oxytocin | Rate of Five Minute Apgar Score < 5 | 1 Participants |
| Foley Catheter and Oxytocin | Rate of Five Minute Apgar Score < 5 | 1 Participants |
Secondary
Rate of Neonatal Sepsis
Neonatal sepsis \[positive blood or cerebrospinal fluid (CSF) cultures\]
Time frame: Duration of hospital stay (average 3.4 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oxytocin | Rate of Neonatal Sepsis | 0 Participants |
| Foley Catheter and Oxytocin | Rate of Neonatal Sepsis | 0 Participants |
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 frame: Time from induction to delivery (average 14.2 hours)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin | Time From Induction to Delivery (Hours) | 14.23 hours | Standard Deviation 8.19 |
| Foley Catheter and Oxytocin | Time From Induction to Delivery (Hours) | 14.16 hours | Standard Deviation 6.97 |