N/A
N=129
Outpatient Foley For Starting Induction of Labor at TErm
Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT02756689 ↗Enrolled (actual)
129
Serious AEs
21.7%
Results posted
Jul 2019
Primary outcome: Primary: Total Time From Admission to Delivery — 13.5; 12.4 hours — p=0.38
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Inpatient cervical ripening (Other); Outpatient cervical ripening (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Time From Admission to Delivery |
13.5; 12.4 | 0.38 |
| SECONDARY Total Hospital Duration |
2.7; 2.6 | 0.29 |
| SECONDARY Number of Participants Using Acetaminophen |
6; 13 | 0.09 |
| SECONDARY Number of Participants Calling the Obstetrical Triage Unit |
0; 4 | 0.12 |
| SECONDARY Number of Participants Admitted Prior to the Scheduled Induction of Labor Time |
3; 10 | 0.06 |
| SECONDARY Number of Participants With Spontaneous Rupture of Membranes Between Foley Bulb Placement and Admission |
5; 4 | 0.74 |
| SECONDARY Nonreassuring Fetal Heart Tracings 30-minutes After Foley Bulb Placement. |
0; 0 | 1 |
| SECONDARY Total Duration of Time of Neuraxial Anesthesia Use |
8.7; 8.4 | 0.82 |
| SECONDARY Total Duration of Time From Rupture of Membranes Until Delivery |
6.2; 5.5 | 0.38 |
| SECONDARY Maximum Oxytocin Rate |
16.4; 17.8 | 0.42 |
| SECONDARY Highest Maternal Intrapartum Temperature |
36.8; 36.7 | 0.06 |
| SECONDARY Number of Participants With Chorioamnionitis |
3; 3 | >0.99 |
| SECONDARY Number of Participants With Meconium-stained Fluid |
11; 8 | 0.43 |
| SECONDARY Number of Participants With Neonates With Shoulder Dystocia |
7; 2 | 0.09 |
| SECONDARY Number of Participants Who Had a Cesarean Delivery |
3; 2 | 0.68 |
| SECONDARY Number of Participants With an Operative Vaginal Delivery |
6; 5 | 0.73 |
| SECONDARY Postpartum Hemorrhage |
1; 0 | 0.5 |
| SECONDARY Number of Participants With Endometritis |
1; 1 | >0.99 |
| SECONDARY Number of Participants With Readmission Within 30 Days |
0; 1 | >0.99 |
| SECONDARY Number of Neonates With a 5-minute Apgar Score Less Than 7 |
1; 0 | 0.5 |
| SECONDARY Number of Neonates With Umbilical Artery Cord pH < 7.1 |
4; 1 | 0.37 |
| SECONDARY Number of Neonates With an Umbilical Cord Artery Base Deficit Less Than Negative 12 |
1; 0 | >0.99 |
| SECONDARY Number of Neonates With Birth Injuries |
2; 1 | 0.62 |
| SECONDARY Number of Neonates Admitted to the Neonatal Intensive Care Unit Admissions |
5; 5 | >0.99 |
| SECONDARY Patient Satisfaction Six Simple Questions, Q1 |
7; 7 | 0.234 |
| SECONDARY Patient Satisfaction (Six Simple Questions, Question 2) |
7; 7 | 0.68 |
| SECONDARY Patient Satisfaction (Six Simple Questions, Question 3) |
1; 1 | 0.77 |
| SECONDARY Patient Satisfaction (Six Simple Questions, Question 4) |
7; 7 | 0.5 |
| SECONDARY Patient Satisfaction (Six Simple Questions, Question 5) |
1; 1 | 0.75 |
| SECONDARY Patient Satisfaction (Six Simple Questions, Question 6) |
7; 7 | 0.75 |
| SECONDARY Patient Satisfaction (Lady-X Survey, Question 1) |
1; 1 | 0.29 |
| SECONDARY Patient Satisfaction (Lady-X Survey, Question 2) |
1; 1 | 0.42 |
| SECONDARY Patient Satisfaction (Lady-X Survey, Question 3) |
1; 1 | 0.96 |
| SECONDARY Patient Satisfaction (Lady-X Survey, Question 4) |
1; 1 | 0.75 |
| SECONDARY Patient Satisfaction (Lady-X Survey, Question 5) |
1; 1 | 0.57 |
| SECONDARY Patient Satisfaction (Lady-X Survey, Question 6) |
1; 1 | 0.39 |
| SECONDARY Patient Satisfaction (Lady-X, Question 7) |
1; 1 | 0.24 |
| SECONDARY Patient Satisfaction (Labor Pain Scale, Question 1) |
59.5; 70 | 0.12 |
| SECONDARY Patient Satisfaction (Labor Pain Scale, Question 2) |
50; 70 | 0.06 |
| SECONDARY Patient Satisfaction (Labor Pain Scale, Question 3) |
20; 15 | 0.83 |
| SECONDARY Patient Satisfaction (Labor Pain Scale, Question 4) |
99; 99 | 0.60 |
Summary
The investigators are performing a randomized controlled-trial investigating starting cervical ripening in the outpatient setting with a mechanical method, the transcervical Foley catheter. This is a pilot study to establish the efficacy of this method in decreasing time as in inpatient and evaluate patient satisfaction.
Eligibility Criteria
Inclusion Criteria
- Age ≥18
- Multiparous
- Singleton gestation
- Gestational age between 39+0 and 42+0
- Vertex presentation
- Cervix ≤ 3 cm. If cervix is between 2 and 3 cm dilated, it must be <80% effaced
- No prior cesarean section or uterine surgery
- Resides within Jefferson County, Alabama.
- Access to a telephone
- Reliable transportation
Exclusion Criteria
- Unsuitable for outpatient Foley placement management (IUGR, oligohydramnios, prior cesarean delivery, gestational hypertension, preeclampsia, or uncontrolled chronic hypertension, complex maternal disease, provider discretion). Any patient with pregestational or gestational diabetes on medications will be excluded.
- Latex allergy
- Contraindication to induction of labor
- Evidence of labor
- Fetal anomaly or demise
- Inability to given consent (non-English speaking, inability to read or write)
Data sourced from ClinicalTrials.gov (NCT02756689). 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.