Patient Satisfaction of Cervical Ripening in an Outpatient Setting
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|ClinicalTrials.gov Identifier: NCT01605474|
Recruitment Status : Unknown
Verified May 2012 by Gregory W. Lau, MD, Cedars-Sinai Medical Center.
Recruitment status was: Recruiting
First Posted : May 25, 2012
Last Update Posted : May 25, 2012
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy||Other: Patient discharged home after foley bulb placement. Other: Inpatient||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety, Efficacy, and Patient Satisfaction of Cervical Ripening With Transcervical Use of the Foley Catheter in an Outpatient Setting|
|Study Start Date :||April 2012|
|Estimated Primary Completion Date :||July 2014|
Active Comparator: Outpatient Cervical Ripening
Patients who are randomized to this arm will be allowed discharged home for 12 hours after fetal status is assessed and noted to be reassuring with the foley bulb in place. They will return sooner if they experience rupture of membranes or enter active labor or if the foley bulb falls out.
Other: Patient discharged home after foley bulb placement.
The patient will be discharged home after fetal status is evaluated and noted to be reassuring. A 16 French foley bulb insufflated with 30 cc of normal saline will be placed and secured to the patient's inner thigh.
Other Name: Foley bulb (16 French)
No Intervention: Inpatient Cervical Ripening
In this arm, the fetus will be assessed and a foley bulb placed but these patients will be kept in the hospital.
The patients will not be discharged home after assessment and placement of the foley catheter.
Other Name: Foley Bulb (16 French)
- Cesarean section rate [ Time Frame: 2 years ]Cesarean delivery rate between groups
- Patient satisfaction (Pain /discomfort) [ Time Frame: 2 year ]Patient satisfaction. Administering a questionaire on which the patient will rate her pain/discomofrt during the placement of the foley bulb and her pain/discomfort while undergoing labor. The Wong Baker Faces scale will be used to assess this measure.
- Apgar scores [ Time Frame: 2 years ]Apgar scores
- NICU admissions [ Time Frame: 2 years ]Neonatal ICU admissions after delivery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01605474
|Contact: Tania F Esakoff, MDemail@example.com|
|Contact: Gregory W Lau, MDfirstname.lastname@example.org|
|United States, California|
|Cedars-Sinai Medical Center||Recruiting|
|Los Angeles, California, United States, 90048|
|Principal Investigator: Tania F Esakoff, MD|
|Sub-Investigator: Gregory W Lau, MD|
|Sub-Investigator: Steve Rad, MD|
|Principal Investigator:||Tania Esaoff, MD||Cedars-Sinai Medical Center, Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine|