Prehospital Cervical Ripening Before Induction and the Maternal Experience
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 15 - 50 |
| Updated: | 4/2/2016 |
| Start Date: | July 2012 |
| Contact: | Kirsten Salmeen, MD |
| Email: | salmeenk@obgyn.ucsf.edu |
| Phone: | 415-353-1256 |
Randomized Controlled Trial of Prehospital Cervical Ripening With an Outpatient Transcervical Foley Balloon and the Duration of Induction and Maternal Satisfaction
This is a randomized study evaluating the impact of pre-hospital cervical ripening with a
transcervical Foley balloon before labor induction in full-term pregnancies on the length of
inpatient labor induction and maternal satisfaction with the labor induction process. The
investigators hypothesize that women who receive pre-hospital cervical ripening will have a
shorter duration of inpatient labor induction as compared to women without pre-hospital
cervical ripening.
transcervical Foley balloon before labor induction in full-term pregnancies on the length of
inpatient labor induction and maternal satisfaction with the labor induction process. The
investigators hypothesize that women who receive pre-hospital cervical ripening will have a
shorter duration of inpatient labor induction as compared to women without pre-hospital
cervical ripening.
Labor induction is a common procedure among pregnant patients at term. This process involves
a period of cervical preparation ("ripening") for women who have an "unfavorable" cervical
examination at the time labor induction is scheduled. Cervical ripening may take place with
pharmacologic or mechanical strategies, which at this time are traditionally administered on
an inpatient basis. This process can 24 or more hours, resulting in a lengthy
hospitalization with the associated costs and frustrations for both patients and L&D staff.
The proposed study is a randomized, controlled trial to explore the following research
question: Among women with full-term pregnancies requiring labor induction, does
pre-hospital, outpatient cervical ripening reduce the amount of inpatient time needed to
achieve delivery as compared to no pre-hospital cervical ripening? As a secondary objective,
we also wish to explore if outpatient cervical ripening is acceptable to patients.
This study will involve randomizing eligible and consenting women who have been scheduled
for labor induction by their obstetrical providers into a pre-hospital cervical ripening
(intervention) group or a no pre-hospital ripening (control) group. A trans-cervical Foley
balloon (TCFB) will be used for outpatient pre-hospital cervical ripening in women
randomized to the intervention group. No pre-hospital ripening will be performed for women
in the control group. Both groups will be admitted for induction as scheduled and will
undergo labor induction according to a specified, Bishop-score based induction protocol,
which may or may not include a TCFB. We will compare the duration of inpatient stays from
admission until delivery between the groups as well as satisfaction with the pre-hospital
period and labor and delivery experience. Maternal and neonatal outcomes will also be
compared between the two groups.
a period of cervical preparation ("ripening") for women who have an "unfavorable" cervical
examination at the time labor induction is scheduled. Cervical ripening may take place with
pharmacologic or mechanical strategies, which at this time are traditionally administered on
an inpatient basis. This process can 24 or more hours, resulting in a lengthy
hospitalization with the associated costs and frustrations for both patients and L&D staff.
The proposed study is a randomized, controlled trial to explore the following research
question: Among women with full-term pregnancies requiring labor induction, does
pre-hospital, outpatient cervical ripening reduce the amount of inpatient time needed to
achieve delivery as compared to no pre-hospital cervical ripening? As a secondary objective,
we also wish to explore if outpatient cervical ripening is acceptable to patients.
This study will involve randomizing eligible and consenting women who have been scheduled
for labor induction by their obstetrical providers into a pre-hospital cervical ripening
(intervention) group or a no pre-hospital ripening (control) group. A trans-cervical Foley
balloon (TCFB) will be used for outpatient pre-hospital cervical ripening in women
randomized to the intervention group. No pre-hospital ripening will be performed for women
in the control group. Both groups will be admitted for induction as scheduled and will
undergo labor induction according to a specified, Bishop-score based induction protocol,
which may or may not include a TCFB. We will compare the duration of inpatient stays from
admission until delivery between the groups as well as satisfaction with the pre-hospital
period and labor and delivery experience. Maternal and neonatal outcomes will also be
compared between the two groups.
Inclusion Criteria:
- Intrauterine pregnancy
- Cephalic presentation
- Greater than 36 weeks estimated gestational age
- Reassuring fetal status
- Normal amniotic fluid index
- Clinical indication for induction of labor
Exclusion Criteria:
- Prior cesarean section
- Bishop score on cervical examination ≥ 6
- Unreliable transportation
- Home > 30 minutes from the hospital
- Non-reassuring fetal status
- Abnormal amniotic fluid index
- Other indication for immediate hospitalization
We found this trial at
1
site
Click here to add this to my saved trials
