Pregnancy RelatedFrIENDlyNCT03450408
Foley Bulb Insertion Method: Blind vs. Direct
A study testing Method of placement of Foley bulb transcervical dilator in people with Pregnancy Related, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
The investigators will compare, in a randomized clinical trial, two methods of placement (placement with a gloved hand vs. placement with a sterile speculum) of a Foley bulb transcervical dilator. The primary outcome is rate of infection. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Method of placement of Foley bulb transcervical dilator
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 372 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2018to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women between the ages of 18 and 50 years
- Induction of labor
- Plan for Foley bulb placement by the managing obstetrics team
Who cannot join
- Patient unwilling or unable to provide consent
- Fetal demise or major congenital anomaly
- Immunosuppressed patients: i.e., taking systemic immunosuppressants or steroids (e.g. transplant patients; not including steroids for lung maturity), HIV with CD4<200, or other
- Fever (>38°C) in the 48 hours prior to presentation for induction of labor
- Use of anti-pyretic agent (i.e., acetaminophen) in the eight hours preceding admission for induction of labor
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch John Sealy Hospital
Galveston, Texas, 77555
About this study
Official title: Foley Bulb Insertion by Blind Placement Versus Direct Visualization: A Randomized Controlled Trial
The investigators will compare, in a randomized clinical trial, two methods of placement (placement with a gloved hand vs. placement with a sterile speculum) of a Foley bulb transcervical dilator. The primary outcome is rate of infection.
Read the detailed description
The target population for this study is women who present for scheduled induction of labor. If there is a decision by the obstetric team to place a transcervical Foley dilator for cervical ripen-ning, the obstetric team will notify the research team so that the patient may be screened for the study. If the patient consents to participation, written informed consent will be obtained by person-to-person contact. The PI, study coordinator, or a collaborator will be responsible for the in-formed consent. After informed consent is obtained, the patient will be randomized to the study group (digital placement) or the control group (placement with a sterile speculum).
The control group will undergo induction of labor by placement via sterile speculum of a 22-French transcervical Foley catheter. The cervix is visualized with a sterile vaginal speculum and cleaned with iodine or chlorhexidine. A Foley catheter is introduced into the cervix and the bal-loon is filled with 60 ml of sterile 0.9% NaCl. The Foley catheter will be left in place for at least 12 hours, and no longer than 24 hours. After placement standard intrapartum management of the patient will ensue.
The study group will undergo induction of labor by digital blind placement of a 22-French trans-cervical Foley catheter. A Foley catheter is introduced into the cervix using digits and hands wearing sterile gloves and the balloon is filled with 60 ml of sterile 0.9% NaCl. The Foley catheter will be left in place for at least 12 hours, and no longer than 24 hours. After placement standard intrapartum management of the patient will ensue.
If cervix remains unfavorable after extraction of the dilators (< 3cm and at most 60% effaced), a second Foley catheter will be used in this case for a maximum of 12 hrs. No crossover will be allowed. In other words, a second Foley bulb will be placed in the same manner as the first assignment arm.
In any attempts, if the Foley bulb is not able to be placed in either insertion technique , a prostaglandin agent for cervical ripening may be used and insertion of the mechanical dilator can be re-attempted at a later time, as is the standard of care at our institution. No cross over will be allowed.
This will be an unblinded randomized clinical trial.
No significant adverse effects are expected with the use of transcervical Foley catheters for mechanical dilation. The most significant risks are vaginal bleeding due to cervical trauma and incidental rupture of membranes, as well as pain or discomfort with placement. The patient will undergo inpatient induction of labor, so any adverse reaction would be promptly detected and addressed.
- Conditions
- Pregnancy Related
- Being tested
- Method of placement of Foley bulb transcervical dilator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Method of placement of Foley bulb transcervical dilatorProcedure or surgery
This trial will assess two methods used to place a Foley bulb transcervical dilator.
| Study group | Role | What they receive |
|---|---|---|
| Placement with gloved hand | Active comparator | The Foley bulb transcervical dilator will be placed blindly with a gloved hand. Receives: Procedure: Method of placement of Foley bulb transcervical dilator |
| Placement with sterile speculum | Active comparator | The cervix will be directly visualized using a sterile speculum, and an instrument will be used to advance the Foley bulb transcervical dilator into the cervical os. Receives: Procedure: Method of placement of Foley bulb transcervical dilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection
Pooled maternal infection
Measured: Labor to 30 days postpartum
Secondary outcomes (6)
Maternal fever
Greater than or equal to 38 degrees Celsius
Measured: From beginning of labor process to time of discharge, up to seven days
Request for pain relief
Request for IV pain medications or epidural placement
Measured: Within 30 minutes of placement procedure
Vaginal bleeding
In the time period immediately following placement
Measured: Within 30 minutes of placement procedure
Artificial rupture of membranes
Rupture of amniotic sac
Measured: At time of placement of Foley bulb transcervical dilator
Chorioamnionitis or "triple I"
Presumptive or confirmed diagnosis
Measured: From beginning of labor process until time of delivery
Endometritis
Postpartum intrauterine infection
Measured: From time of delivery to 30 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start28 Feb 2018
- Primary completion28 Feb 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 372 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio F Saad, MD, Study chair, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450408
- Sponsor's protocol ID
- 17-0359
- Acronym
- FrIENDly
- Status last verified
- May 2020
- First submitted
- 6 Feb 2018
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kuhlmann MJ, Spencer N, Garcia-Jasso C, Singh P, Abdelwahab M, Vaughn M, Marshall K, Prasad N, Soulsby-Monroy R, Saade GR, Saad AF. Foley Bulb Insertion by Blind Placement Compared With Direct Visualization: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jan 1;137(1):139-145. doi: 10.1097/AOG.0000000000004182.
PubMed 33278290
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foley Bulb Insertion by Blind Placement Versus Direct Visualization: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03450408
- Acronym / sponsor ID
- FrIENDly / 17-0359
- Conditions
- Pregnancy Related
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 372 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 1 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will compare, in a randomized clinical trial, two methods of placement (placement with a gloved hand vs. placement with a sterile speculum) of a Foley bulb transcervical dilator. The primary outcome is rate of infection.
Detailed description
The target population for this study is women who present for scheduled induction of labor. If there is a decision by the obstetric team to place a transcervical Foley dilator for cervical ripen-ning, the obstetric team will notify the research team so that the patient may be screened for the study. If the patient consents to participation, written informed consent will be obtained by person-to-person contact. The PI, study coordinator, or a collaborator will be responsible for the in-formed consent. After informed consent is obtained, the patient will be randomized to the study group (digital placement) or the control group (placement with a sterile speculum).
The control group will undergo induction of labor by placement via sterile speculum of a 22-French transcervical Foley catheter. The cervix is visualized with a sterile vaginal speculum and cleaned with iodine or chlorhexidine. A Foley catheter is introduced into the cervix and the bal-loon is filled with 60 ml of sterile 0.9% NaCl. The Foley catheter will be left in place for at least 12 hours, and no longer than 24 hours. After placement standard intrapartum management of the patient will ensue.
The study group will undergo induction of labor by digital blind placement of a 22-French trans-cervical Foley catheter. A Foley catheter is introduced into the cervix using digits and hands wearing sterile gloves and the balloon is filled with 60 ml of sterile 0.9% NaCl. The Foley catheter will be left in place for at least 12 hours, and no longer than 24 hours. After placement standard intrapartum management of the patient will ensue.
If cervix remains unfavorable after extraction of the dilators (< 3cm and at most 60% effaced), a second Foley catheter will be used in this case for a maximum of 12 hrs. No crossover will be allowed. In other words, a second Foley bulb will be placed in the same manner as the first assignment arm.
In any attempts, if the Foley bulb is not able to be placed in either insertion technique , a prostaglandin agent for cervical ripening may be used and insertion of the mechanical dilator can be re-attempted at a later time, as is the standard of care at our institution. No cross over will be allowed.
This will be an unblinded randomized clinical trial.
No significant adverse effects are expected with the use of transcervical Foley catheters for mechanical dilation. The most significant risks are vaginal bleeding due to cervical trauma and incidental rupture of membranes, as well as pain or discomfort with placement. The patient will undergo inpatient induction of labor, so any adverse reaction would be promptly detected and addressed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placement with gloved hand | Active comparator | Procedure: Method of placement of Foley bulb transcervical dilatorThe Foley bulb transcervical dilator will be placed blindly with a gloved hand. |
| Placement with sterile speculum | Active comparator | Procedure: Method of placement of Foley bulb transcervical dilatorThe cervix will be directly visualized using a sterile speculum, and an instrument will be used to advance the Foley bulb transcervical dilator into the cervical os. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women between the ages of 18 and 50 years
- Induction of labor
- Plan for Foley bulb placement by the managing obstetrics team
Key exclusion criteria (5 listed)
- Patient unwilling or unable to provide consent
- Fetal demise or major congenital anomaly
- Immunosuppressed patients: i.e., taking systemic immunosuppressants or steroids (e.g. transplant patients; not including steroids for lung maturity), HIV with CD4<200, or other
- Fever (>38°C) in the 48 hours prior to presentation for induction of labor
- Use of anti-pyretic agent (i.e., acetaminophen) in the eight hours preceding admission for induction of labor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Method of placement of Foley bulb transcervical dilatorThis trial will assess two methods used to place a Foley bulb transcervical dilator. | Procedure or surgery | Placement with gloved hand, Placement with sterile speculum |
Primary outcome
Infection
Time frame: Labor to 30 days postpartum
Pooled maternal infection
6 secondary outcomes
Maternal fever
Time frame: From beginning of labor process to time of discharge, up to seven days
Request for pain relief
Time frame: Within 30 minutes of placement procedure
Vaginal bleeding
Time frame: Within 30 minutes of placement procedure
Artificial rupture of membranes
Time frame: At time of placement of Foley bulb transcervical dilator
Chorioamnionitis or "triple I"
Time frame: From beginning of labor process until time of delivery
Endometritis
Time frame: From time of delivery to 30 days postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
- Derived from this study: PubMed 33278290Kuhlmann MJ, Spencer N, Garcia-Jasso C, Singh P, Abdelwahab M, Vaughn M, Marshall K, Prasad N, Soulsby-Monroy R, Saade GR, Saad AF. Foley Bulb Insertion by Blind Placement Compared With Direct Visualization: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jan 1;137(1):139-145. doi: 10.1097/AOG.0000000000004182.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio F Saad, MD study chair
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Method of placement of Foley bulb transcervical dilator in people with Pregnancy Related, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection (time frame: Labor to 30 days postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03450408, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2020.