Primary outcomeMean· From baseline to the time of delivery (baseline is from admission), up to 7 days
Total Time From Admission to Delivery
| Group | Value (hours) | Spread |
|---|---|---|
| Inpatient Group | 13.5 | 7.0 |
| Outpatient Group (Intervention) | 12.4 | 7.4 |
Trial · Interventional
CompletedNot applicableResults postedRegistry dataOutpatient Foley For Starting Induction of Labor at TErm
Short name OFFSITE
NCTNCT02756689 (opens ClinicalTrials.gov in a new tab)Other idF151022005
This trial does not test a peptide that PepBank tracks.
- Measures Oxytocin, does not give it. It appears in an outcome measure.
Overview
- Status
- Completed
- Phase
- Not applicable
- Enrollment
- 129 participants (actual)
- Sponsor
- University of Alabama at Birmingham · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- Mar 2016
- Primary completion
- Oct 2017
- Completion
- Oct 2017
- First posted
- 29 Apr 2016 (estimated)
- Last update posted
- 9 Jul 2019
- Conditions
- Pregnancy
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201620172018
- N/A
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Inpatient cervical ripeningOther
- Outpatient cervical ripeningOther
Arms2
Active comparator
Inpatient cervical Ripening
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Active comparator
Outpatient cervical Ripening
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Primary outcomes1
Outcomes the sponsor listed as primary.
Total Time From Admission to Delivery
Time frame · From baseline to the time of delivery (baseline is from admission), up to 7 days
Secondary outcomes(20)
Total Hospital Duration
Time frame · From admission time to the hospital until discharge from the hospital, up to 7 days
Number of Participants Using Acetaminophen
Time frame · From placement of Foley bulb to 24 hours.
Number of Participants Calling the Obstetrical Triage Unit
Time frame · From placement of Foley bulb to 24 hours.
Number of Participants Admitted Prior to the Scheduled Induction of Labor Time
Time frame · From placement of Foley bulb to 24 hours.
Number of Participants With Spontaneous Rupture of Membranes Between Foley Bulb Placement and Admission
Time frame · From placement of Foley bulb to 24 hours.
Nonreassuring Fetal Heart Tracings 30-minutes After Foley Bulb Placement.
Time frame · From placement until 30 minutes.
Total Duration of Time of Neuraxial Anesthesia Use
Time frame · Assessed from baseline to delivery, up to 3 days
Total Duration of Time From Rupture of Membranes Until Delivery
Time frame · Assessed from baseline to delivery, up to 3 days
Maximum Oxytocin Rate
Time frame · Assessed from baseline to delivery, up to 3 days
Highest Maternal Intrapartum Temperature
Time frame · Assessed from baseline to delivery, up to 3 days
Number of Participants With Chorioamnionitis
Time frame · Assessed from baseline to delivery.
Number of Participants With Meconium-stained Fluid
Time frame · Assessed from baseline to delivery.
Number of Participants With Neonates With Shoulder Dystocia
Time frame · Assessed at delivery.
Number of Participants Who Had a Cesarean Delivery
Time frame · Assessed from baseline to delivery.
Number of Participants With an Operative Vaginal Delivery
Time frame · Assessed at delivery.
Postpartum Hemorrhage
Time frame · Assessed at delivery.
Number of Participants With Endometritis
Time frame · Assessed from delivery until 30 days post-discharge.
Number of Participants With Readmission Within 30 Days
Time frame · Assessed from time of discharge until 30 days post-discharge.
Number of Neonates With a 5-minute Apgar Score Less Than 7
Time frame · Assessed at time of delivery up to 5-minutes post-delivery.
Registry description
Apgar scores are assigned to all births. These are universally performed and assigned in the United States. The scoring system is between 0-10. 0 is the minimum score and 10 is the maximum. Lower scores are worse than higher scores.
Number of Neonates With Umbilical Artery Cord pH < 7.1
Time frame · Assessed at time of delivery up to 5-minutes post-delivery.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeMean· From admission time to the hospital until discharge from the hospital, up to 7 days
Total Hospital Duration
| Group | Value (days) | Spread |
|---|---|---|
| Inpatient Group | 2.7 | 0.6 |
| Outpatient Group (Intervention) | 2.6 | 0.5 |
Secondary outcomeCount of participants· From placement of Foley bulb to 24 hours.
Number of Participants Using Acetaminophen
| Group | Value (Participants) |
|---|---|
| Inpatient Group | 6 |
| Outpatient Group (Intervention) | 13 |
Secondary outcomeCount of participants· From placement of Foley bulb to 24 hours.
Number of Participants Calling the Obstetrical Triage Unit
| Group | Value (Participants) |
|---|---|
| Inpatient Group | 0 |
| Outpatient Group (Intervention) | 4 |
Secondary outcomeCount of participants· From placement of Foley bulb to 24 hours.
Number of Participants Admitted Prior to the Scheduled Induction of Labor Time
| Group | Value (Participants) |
|---|---|
| Inpatient Group | 3 |
| Outpatient Group (Intervention) | 10 |
Secondary outcomeCount of participants· From placement of Foley bulb to 24 hours.
Number of Participants With Spontaneous Rupture of Membranes Between Foley Bulb Placement and Admission
| Group | Value (Participants) |
|---|---|
| Inpatient Group | 5 |
| Outpatient Group (Intervention) | 4 |
Secondary outcomeCount of participants· From placement until 30 minutes.
Nonreassuring Fetal Heart Tracings 30-minutes After Foley Bulb Placement.
| Group | Value (Participants) |
|---|---|
| Inpatient Group | 0 |
| Outpatient Group (Intervention) | 0 |
Secondary outcomeMean· Assessed from baseline to delivery, up to 3 days
Total Duration of Time of Neuraxial Anesthesia Use
| Group | Value (hours) | Spread |
|---|---|---|
| Inpatient Group | 8.7 | 6.3 |
| Outpatient Group (Intervention) | 8.4 | 6.9 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Inpatient GroupAdverse Events: none | 0 / 64 | 16 / 64 | 0 / 64 |
| Outpatient GroupAdverse events: none | 0 / 65 | 12 / 65 | 0 / 65 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies8
Studies that cite this trial.
Studies with results
0 studies on this page
Indexing hint: Meta-analysis (pooled) · 2012
Mechanical methods for induction of labour.
Jozwiak et al. 2012The Cochrane database of systematic reviewscited by 89
PMID 22419277DOI 10.1002/14651858.cd001233.pub2PUB-22419277
Full text at the publisher
Indexing hint: Meta-analysis (pooled) · 2009
Intravenous oxytocin alone for cervical ripening and induction of labour.
Alfirevic et al. 2009The Cochrane database of systematic reviewscited by 78
PMID 19821304PMC4164045DOI 10.1002/14651858.cd003246.pub2PUB-19821304
Rights unknown
More studies
6 studies on this page
Indexing hint: Randomized controlled trial · 2018
Outpatient Foley Catheter for Induction of Labor in Parous Women: A Randomized Controlled Trial.
Kuper et al. 2018Obstetrics and gynecologycited by 28
PMID 29889751DOI 10.1097/aog.0000000000002678PUB-29889751
Full text at the publisher
PubMed tag: none · 2014
The timing of adverse events with Foley catheter preinduction cervical ripening; implications for outpatient use.
Sciscione et al. 2014American journal of perinatologycited by 28
PMID 24347259DOI 10.1055/s-0033-1359718PUB-24347259
Full text at the publisher
Indexing hint: Randomized controlled trial · 2014
Foley catheter compared with the controlled-release dinoprostone insert: a randomized controlled trial.
Edwards et al. 2014Obstetrics and gynecologycited by 42
PMID 24807327DOI 10.1097/aog.0000000000000238PUB-24807327
Full text at the publisher
Indexing hint: Randomized controlled trial · 2013
Outpatient Foley catheter versus inpatient prostaglandin E2 gel for induction of labour: a randomised trial.
Henry et al. 2013BMC pregnancy and childbirthcited by 68
PMID 23356673PMC3564932DOI 10.1186/1471-2393-13-25PUB-23356673
CC BY
Indexing hint: Randomized controlled trial · 2008
Transcervical Foley catheter with and without oxytocin for cervical ripening: a randomized controlled trial.
Pettker et al. 2008Obstetrics and gynecologycited by 39
PMID 18515515DOI 10.1097/aog.0b013e31817615a0PUB-18515515
Full text at the publisher
Indexing hint: Randomized controlled trial · 2001
Transcervical Foley catheter for preinduction cervical ripening in an outpatient versus inpatient setting.
Sciscione et al. 2001Obstetrics and gynecologycited by 57
PMID 11704164DOI 10.1016/s0029-7844(01)01579-4PUB-11704164
Full text at the publisher
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedAlfirevic Z, Gyte GM, Nogueira Pileggi V, Plachcinski R, Osoti AO, Finucane EM. Home versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2020 Aug 27;8(8):CD007372. doi: 10.1002/14651858.CD007372.pub4. PMID 32852803
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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)
PepBank is a research reference. Talk to a doctor before you use any peptide.