Pregnancy Related Clinical Trial
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05017974 -
Research on Improving Sleep During Pregnancy
|
N/A | |
Completed |
NCT03284515 -
Vaccination In Pregnancy Gene Signature: VIP Signature Study
|
||
Recruiting |
NCT05969795 -
Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support
|
Phase 1 | |
Recruiting |
NCT06051201 -
Innovation for Small-scale Experiments: ReceptIVFity Test
|
N/A | |
Recruiting |
NCT04828382 -
Prospective Study of Pregnancy in Women With Cystic Fibrosis
|
||
Enrolling by invitation |
NCT04527926 -
STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy
|
N/A | |
Recruiting |
NCT04278651 -
Early Antenatal Support for Iron Deficiency Anemia
|
Phase 4 | |
Recruiting |
NCT04405700 -
Measuring Adverse Pregnancy and Newborn Congenital Outcomes
|
||
Recruiting |
NCT06258902 -
Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
|
||
Completed |
NCT05487196 -
Effectiveness of Clonidine, Dexmedetomidine, and Fentanyl Adjuncts for Labor Epidural Analgesia
|
Phase 2 | |
Completed |
NCT03750968 -
Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects
|
Phase 2 | |
Enrolling by invitation |
NCT06127277 -
Next4You: A Fully Mobile Relationships Based Program for Youth in Foster Care
|
N/A | |
Completed |
NCT05897697 -
Assessing Women's Preferences for Postpartum Thromboprophylaxis: the Prefer-Postpartum Study
|
||
Recruiting |
NCT05899101 -
The Impact of Opioid and Cannabis Exposure on Fetal Growth
|
||
Completed |
NCT05502510 -
Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
|
||
Completed |
NCT04296396 -
Opioid Prescription After Cesarean Trial
|
Phase 3 | |
Not yet recruiting |
NCT06069869 -
Multiple Micronutrient Supplementation (MMS) Iron Dose Acceptability Crossover Trial
|
Phase 3 | |
Not yet recruiting |
NCT06069856 -
Multiple Micronutrient Supplementation (MMS) IFA- Iron Dose Acceptability Crossover Trial
|
Phase 3 | |
Not yet recruiting |
NCT06079918 -
Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania
|
Phase 3 | |
Not yet recruiting |
NCT04960800 -
Effect of a Specific Exercise Program During Pregnancy on Diastasis Recti Abdominis
|
N/A |